<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02185001</url>
  </required_header>
  <id_info>
    <org_study_id>TLKC-0001</org_study_id>
    <nct_id>NCT02185001</nct_id>
  </id_info>
  <brief_title>Repair of Medial Patellofemoral Ligament Compared to Conservative Treatment for First Time Patella Dislocation</brief_title>
  <official_title>Repair of Medial Patellofemoral Ligament Compared to Conservative Treatment for First Time Patella Dislocation; A Randomized Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orthopedic Specialty Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orthopedic Specialty Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: The forces involved in a patella dislocation event can cause significant&#xD;
      collateral damage involving the articular cartilage of the patella femoral joint. As a&#xD;
      result, prevention of recurrent patella dislocation and the associated disability and&#xD;
      morbidity has generated significant interest in the orthopedic community. Historically,&#xD;
      nonoperative treatment for first time patella dislocation has been problematic due to high&#xD;
      redislocation rates. Nonoperative protocols generally involve bracing and/or immobilization,&#xD;
      followed by physical therapy (1). Surgical approaches to recurrent patella dislocation, both&#xD;
      soft tissue and boney realignment operations, have also had mixed results, including low&#xD;
      success rates, associated complications, and variable rates of return to functional activity&#xD;
      (2,3,4). This study is intended to compare the outcomes of a relatively low-risk Medial&#xD;
      Patellofemoral Ligament (MPFL) direct repair procedure to conservative treatment.&#xD;
&#xD;
      Methods/Design: This study is designed as a two arm randomized prospective trial.&#xD;
      Approximately fifty subjects will be randomly assigned to either a surgical or non-operative&#xD;
      arm by means of a computer randomized allocation program. All subjects will have X-Ray Images&#xD;
      and Magnetic Resonance Imaging (MRI) to determine the site of the MPFL damage, and to&#xD;
      determine if any excluding conditions exist. Subjects randomized to the surgical group will&#xD;
      have repair of the MPFL. Routine aftercare will consist of physical therapy in a clinic that&#xD;
      has agreed to follow our protocol. Subjects randomized to the nonoperative group will receive&#xD;
      2 weeks of patellar immobilization, followed by patellar stabilization bracing with physical&#xD;
      therapy for approximately 12 weeks. Physical therapy will progress through five phases with&#xD;
      the goal of gait normalization, full range of motion and return to sport. Both arms will be&#xD;
      given outcome questionnaires and physical activity assessments before treatment, and at one,&#xD;
      three, six, twelve, and twenty four month intervals.&#xD;
&#xD;
      Discussion: This prospective randomized trial will investigate the results of direct repair&#xD;
      of the medial patellofemoral ligament and conservative treatment by applying subjective&#xD;
      outcome measures (Kujala scores), and exam findings to determine MPFL functional restoration&#xD;
      or redislocation. Subjects will be examined in the clinic setting at 10 days, one month, and&#xD;
      six months post trauma. Any reported recurrent dislocation or subluxation event will be&#xD;
      documented during recovery. All subjects will receive merchant x-ray views at 3 months with&#xD;
      manual lateral translation of the patella.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Historic treatment for first time patella dislocation has been largely&#xD;
      conservative. Treatment options include nonoperative treatment and a large variety of&#xD;
      operative options. Nonoperative treatment, usually consists of bracing and/or immobilization&#xD;
      followed by physical therapy, has been problematic due to a relatively high reported&#xD;
      redislocation rate(1). The forces involved in a patella dislocation event can damage the&#xD;
      articular cartilage of the patella femoral joint. As a result, prevention of recurrent&#xD;
      patella dislocation and the associated disability and morbidity has generated significant&#xD;
      interest in the orthopedic community.&#xD;
&#xD;
      Historic surgical approaches to recurrent patella dislocation have had mixed results. The&#xD;
      isolated &quot;lateral release&quot;, has been shown to have a very low success rate(2), while&#xD;
      associated complications have been appreciated. Lateral release procedures are now more often&#xD;
      performed in conjunction with other proximal or distal realignment procedures(3). More&#xD;
      aggressive bone realignment procedures such as tibial tubercle transfers have the&#xD;
      disadvantage of reported poor long term functional recoveries and low &quot;return to sport&quot;&#xD;
      rates(4,5).&#xD;
&#xD;
      There has been increasing interest in ligament reconstruction for patella dislocation. The&#xD;
      ligament of interest is the medial patella-femoral ligament (MPFL), which is essentially a&#xD;
      thickened band of the medial capsule of the knee. The MPFL has been established as the&#xD;
      primary constraint to patella dislocation. This ligament extends from a point just anterior&#xD;
      to the attachment of the medial collateral ligament to the medial aspect of the patella, and&#xD;
      is routinely disrupted with a patella dislocation event. The goals of reconstruction&#xD;
      procedures are to replace and/or augment this band of tissue. While many reports of the&#xD;
      results of MPFL reconstruction have been good to excellent, there are significant associated&#xD;
      risks of complication, prolonged recovery, and associated graft costs or autograft harvest&#xD;
      morbidity.&#xD;
&#xD;
      An alternative approach to MPFL functional restoration, and the subject of this study&#xD;
      proposal, is a direct repair of the MPFL. Variations of this approach have been previously&#xD;
      studied. A basic understanding of established injury patterns to the MPFL is requisite to&#xD;
      evaluating the limitations to these studies.&#xD;
&#xD;
      Studies evaluating MPFL injury by MRI have shown that acute patella dislocations have a very&#xD;
      high incidence of associated MPFL injury. The location of the lesion in the ligament can be&#xD;
      described in one of four ways: 1) at the patellar attachment, 2) at the femoral attachment,&#xD;
      3) intrasubstance portion of the ligament, or 4) a combined injury pattern. Several studies&#xD;
      have demonstrated varying percent distributions of injury(6,7), but it is clear that all&#xD;
      patterns exist. This conclusion is consistent with the author's experience is treating these&#xD;
      injuries.&#xD;
&#xD;
      Detecting the injury location can also be a challenge. Arthroscopic examination has been&#xD;
      shown to be ineffective at determining the location of injury(8) and, in the experience of&#xD;
      the author, MRI evaluation is frequently inaccurate, especially in the chronic or recurrent&#xD;
      patella dislocation setting. The author proposes a functional intraoperative test to&#xD;
      determine the ligament injury location.&#xD;
&#xD;
      Some prior reports have included surgical treatment of MPFL injuries using one technique&#xD;
      only, with results similar to nonoperative treatment. For instance, some studies have&#xD;
      evaluated treating all patella dislocations with repair at the patellar insertion, a&#xD;
      treatment which may have limited or no benefit for patients with injuries at the femoral&#xD;
      attachment of the ligament. There are two limited reports evaluating somewhat similar&#xD;
      techniques, and these reports indicate some of the best results in the literature in the&#xD;
      management of patella-femoral instability (9,10). These results are consistent with the&#xD;
      author's experience with the treatment of this condition.&#xD;
&#xD;
      The subject of this study is to determine the difference in nonoperative and surgical patient&#xD;
      outcomes using contemporary surgical techniques; identifying the location of the injury and&#xD;
      choosing either direct repair or appropriate advancement. We hypothesize that minimally&#xD;
      invasive surgical repair of the MPFL will improve patient outcomes and minimize recurrent&#xD;
      patellar dislocation, when compared to conservative treatment. Our null hypothesis is that&#xD;
      there will be no difference in outcomes between the two groups.&#xD;
&#xD;
      Methods/Design Trial Design - The study design will be a prospective parallel-group,&#xD;
      randomized trial with allocation concealment.&#xD;
&#xD;
      Participants - At least 50 subjects will be recruited by referral from primary care&#xD;
      providers, specialists, urgent care and emergency departments, and physical therapy clinics&#xD;
      within a 50 mile radius of the clinic. Men, women, and minors, aged 10-17 will be recruited.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        -  A first patellofemoral traumatic dislocation&#xD;
&#xD;
        -  A need for reduction&#xD;
&#xD;
        -  An absence of fractures on x-ray exam of the frontal and lateral knee and axial patella&#xD;
&#xD;
        -  An absence of knee ligament lesions with surgical indications (with the exception of the&#xD;
           MPFL)&#xD;
&#xD;
        -  No previous knee surgery&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  A prior episode of patellofemoral dislocation&#xD;
&#xD;
        -  Fractures on x-ray exam of the frontal and lateral knee and axial patella Prior surgery&#xD;
           on the knee&#xD;
&#xD;
        -  Tibial tuberosity-trochlear groove distance greater than 20mm&#xD;
&#xD;
        -  Current pregnancy or plan to become pregnant during the study period. Recruitment - The&#xD;
           recruitment process will consist of two phases. Phase one will consist of a short&#xD;
           screening questionnaire, and phase two will consist of a clinical examination and&#xD;
           questionnaire. Recruitment will remain open until at least fifty subjects that meet the&#xD;
           inclusion criteria agree to participate.&#xD;
&#xD;
      Randomization - After screening and accepting subjects in the recruiting process, subjects&#xD;
      will be randomly assigned to either an operative group or non-operative group by means of&#xD;
      computer randomized sequencing and blind allocation. Random sequence generation will be done&#xD;
      by using Random Allocation Software 1.0.0., and allocation will be concealed by placing&#xD;
      allocations in sequentially numbered, sealed envelopes. Randomization, allocation, and&#xD;
      concealment will be accomplished by an administrative assistant with no interest in the study&#xD;
      or its outcome.&#xD;
&#xD;
      Interventions - All subjects will be briefed on their respective treatment protocols. The&#xD;
      operative group will be advised on the risks of this surgery, including the chance of&#xD;
      recurrent dislocations, as well as the more general risks of infection, DVT/PE, anesthesia&#xD;
      complications, and associated possible complications (Table 1.1). The non-operative group&#xD;
      will be advised of the possible failure of treatment, possibility of recurrent dislocation,&#xD;
      and the possible need for surgery (Table 1.2).&#xD;
&#xD;
      All subjects will receive long standing and sunrise x-rays for diagnostic purposes. An MRI&#xD;
      will be obtained for identifying the site of the lesion for both groups. Additionally, we&#xD;
      will ask the subjects to complete a Kujala Scoring questionnaire and physical activity&#xD;
      assessment as a baseline measurement, with the intention of evaluating and subjectively&#xD;
      comparing the two types of treatment. Treatment for the surgical group will be performed at&#xD;
      an outpatient surgical facility, and the non-operative group will receive treatment at a&#xD;
      physical therapy clinic of their choice.&#xD;
&#xD;
      Surgical Treatment Group - Subjects who are randomized to the surgical group treatment will&#xD;
      undergo surgical repair of their medial patellofemoral ligament. This will be identified&#xD;
      using an MRI scan for the site of the lesion. If this cannot be identified, the following&#xD;
      process will be used to determine the site of the lesion: On physical examination, the point&#xD;
      of maximal tenderness between the patella and the femur will be identified and that will be&#xD;
      the assumed site of traumatic injury to the medial patellofemoral ligament.&#xD;
&#xD;
      Surgery will be performed initially with a diagnostic arthroscopy to evaluate for loose&#xD;
      bodies or chondral damage anywhere in the patellofemoral joint. A video will be taken of this&#xD;
      and provided to the patient postoperatively. If there are no loose bodies or chondral damage&#xD;
      to be treated, the medial patellofemoral ligament will then be repaired.&#xD;
&#xD;
      An incision will be made approximately 2 cm in length over the assumed site of the injury.&#xD;
      The medial patellofemoral ligament will be identified and a tag suture will be applied to it.&#xD;
      Traction on the medial patellofemoral ligament at this location will confirm that this is the&#xD;
      site of primary injury by determining whether there is a firm endpoint with traction. If&#xD;
      there is not a firm endpoint, a secondary incision over the alternate location, either the&#xD;
      patella or the femur, will be made and the medial patellofemoral ligament will be identified&#xD;
      in that location.&#xD;
&#xD;
      Repairs of the medial patellofemoral ligament will be made at all sites opened surgically&#xD;
      whether it be either the femur or the patella, or both. Surgical repair will consist of&#xD;
      providing decortication of the bone at the anatomic location of the medial patellofemoral&#xD;
      ligament. Placement of a single 5 mm metal suture anchor with FiberWire-type sutures and a&#xD;
      repair of the medial patellofemoral ligament using the FiberWire sutures to dock the ligament&#xD;
      into its anatomic location. The repairs will be then be oversewn with #1 Vicryl suture at the&#xD;
      site of the repair.&#xD;
&#xD;
      Following this, the local anesthetic will be applied to the incisions. They will be copiously&#xD;
      irrigated and repaired with absorbable sutures.&#xD;
&#xD;
      The subjects will be placed in a hinged knee brace postoperatively with a range of motion&#xD;
      restriction of 0-45 degrees. Weight bearing will be allowed immediately following surgery.&#xD;
&#xD;
      The subjects will start physical therapy the week of surgery and will begin with quadriceps&#xD;
      strengthening with a restriction of range of motion from 0-45 for the first four weeks&#xD;
      postoperatively followed by unrestricted full range of motion after week six. Full sport&#xD;
      activities will be allowed to be resumed after eight weeks, provided the patient have at&#xD;
      least 85% of the strength in their quadriceps compared to the contralateral side. Actual&#xD;
      progression will be individualized based upon the patient's weekly reassessment and the&#xD;
      presence of any complications.&#xD;
&#xD;
      Postoperative follow-ups will be made at the below-mentioned intervals with appropriate&#xD;
      Kujala scoring and physical activity assessment (Table 2). X-rays will be taken on the first&#xD;
      postoperative visit to confirm location of suture anchor repairs.&#xD;
&#xD;
      Appointments for physical examinations will be made at 7-10 days, 1 month, and three months&#xD;
      after surgery. Any reported recurrent dislocation or subluxation event will be documented&#xD;
      during recovery. All subjects will receive sunrise x-ray views at 3 months with manual&#xD;
      lateral translation of the patella, as part of the study.&#xD;
&#xD;
      Conservative Treatment Group - The conservative treatment protocol is based on accepted&#xD;
      physical therapy models of care and is established relative to patient tolerance for tissue&#xD;
      healing, recovery, and response to modalities and procedures. Actual progression will be&#xD;
      individualized based upon the patient's weekly reassessment and the presence of any&#xD;
      complications. Prevention and minimization of recurrent dislocation, painful subluxation and&#xD;
      osteoarthrosis are paramount in early management scenarios. The post traumatic and post&#xD;
      surgical sequelae of pain, inflammation, swelling, bruising and muscular deactivation will be&#xD;
      managed with acceptable standards of practice and prescribed medications. Prevention and&#xD;
      dissipation of these sequelae, including modifying activities that put excessive stress or&#xD;
      loading on the patellofemoral joint are the initial goals of rehabilitation in concert with&#xD;
      gradual progression of mobility and muscular reactivation techniques. The protocol is divided&#xD;
      into five phases: Phase I and II, 0-4 weeks; Phase III, 5-8 weeks; Phase IV- 9-12 weeks,&#xD;
      Phase V- 13+ weeks (Table 3).&#xD;
&#xD;
      In addition to physical therapy appointments, subjects in the conservative treatment group&#xD;
      will be given physical examination appointments and Kujala outcome scoring questionnaires and&#xD;
      physical activity assessments at the same intervals as the surgical intervention group (Table&#xD;
      2). All subjects will receive sunrise x-ray views at 3 months with manual lateral translation&#xD;
      of the patella, as part of the study.&#xD;
&#xD;
      Blinding-Due to the nature of the study, blinding of subjects after assignment to treatment&#xD;
      groups is not feasible. All records and data will be collected and securely stored in the&#xD;
      Clinical Research Coordinator's office. The data will be blinded before final statistical&#xD;
      analysis by an independent statistician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inadequate patient recruitment and coordinator left organization&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Reported Change in Patellar Stability, Subluxation, or Recurrent Dislocation.</measure>
    <time_frame>24 months, or as reported by subject</time_frame>
    <description>Subjects will be divided into 3 groups relating to patellar stability:&#xD;
Recurrence, indicating that the patient had a recurrent patellofemoral dislocation (total loss of congruence between the patella and trochlea) prior to 24 months.&#xD;
Unstable, indicating that the patient's knee presented with a positive apprehension test or showed signs of subluxation prior to 24 months, but without recurrent dislocation.&#xD;
Stable, indicating that the patient's knee did not show positive signs of episodes of subluxation at 24 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Outcome Measurement (Kujala Test)</measure>
    <time_frame>1, 3, 6, 12, and 24 months</time_frame>
    <description>Patients will be asked to complete the Kujala knee pain questionnaire to record pain and function levels at various points in the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Dislocated Patella</condition>
  <condition>Torn Medial Patellofemoral Ligament</condition>
  <arm_group>
    <arm_group_label>Surgical Treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Direct Medial Patellofemoral Ligament (MPFL) Repair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative Treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Immobilization, stabilization bracing, and physical therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Direct Medial Patellofemoral Ligament (MPFL) Repair</intervention_name>
    <description>The MPFL will be repaired directly at the site of the traumatic injury.</description>
    <arm_group_label>Surgical Treatment Group</arm_group_label>
    <other_name>Surgical Treatment Group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physical therapy</intervention_name>
    <description>Patellar immobilization, stabilization, and strengthening under the direction and guidance of the physician and physical therapist.</description>
    <arm_group_label>Conservative Treatment Group</arm_group_label>
    <other_name>Physiotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  A first patellofemoral traumatic dislocation&#xD;
&#xD;
          -  A need for reduction&#xD;
&#xD;
          -  An absence of fractures on x-ray exam of the frontal and lateral knee and axial&#xD;
             patella&#xD;
&#xD;
          -  An absence of knee ligament lesions with surgical indications (with the exception of&#xD;
             the MPFL)&#xD;
&#xD;
          -  No previous knee surgery&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  A prior episode of patellofemoral dislocation&#xD;
&#xD;
          -  Fractures on x-ray exam of the frontal and lateral knee and axial patella Prior&#xD;
             surgery on the knee&#xD;
&#xD;
          -  Tibial tuberosity-trochlear groove distance greater than 20mm&#xD;
&#xD;
          -  Current pregnancy or plan to become pregnant during the study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey R Lyman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopedic Specialty Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Lyman Knee Clinic</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Maenpaa H, Huhtala H, Lehto MU. Recurrence after patellar dislocation. Redislocation in 37/75 patients followed for 6-24 years. Acta Orthop Scand. 1997 Oct;68(5):424-6. doi: 10.3109/17453679708996255.</citation>
    <PMID>9385239</PMID>
  </reference>
  <reference>
    <citation>Colvin AC, West RV. Patellar instability. J Bone Joint Surg Am. 2008 Dec;90(12):2751-62. doi: 10.2106/JBJS.H.00211.</citation>
    <PMID>19047722</PMID>
  </reference>
  <reference>
    <citation>Arendt EA, Fithian DC, Cohen E. Current concepts of lateral patella dislocation. Clin Sports Med. 2002 Jul;21(3):499-519. doi: 10.1016/s0278-5919(02)00031-5.</citation>
    <PMID>12365240</PMID>
  </reference>
  <reference>
    <citation>Arnbjornsson A, Egund N, Rydling O, Stockerup R, Ryd L. The natural history of recurrent dislocation of the patella. Long-term results of conservative and operative treatment. J Bone Joint Surg Br. 1992 Jan;74(1):140-2. doi: 10.1302/0301-620X.74B1.1732244.</citation>
    <PMID>1732244</PMID>
  </reference>
  <reference>
    <citation>Aglietti P, Buzzi R, De Biase P, Giron F. Surgical treatment of recurrent dislocation of the patella. Clin Orthop Relat Res. 1994 Nov;(308):8-17.</citation>
    <PMID>7955706</PMID>
  </reference>
  <reference>
    <citation>Sillanpaa PJ, Peltola E, Mattila VM, Kiuru M, Visuri T, Pihlajamaki H. Femoral avulsion of the medial patellofemoral ligament after primary traumatic patellar dislocation predicts subsequent instability in men: a mean 7-year nonoperative follow-up study. Am J Sports Med. 2009 Aug;37(8):1513-21. doi: 10.1177/0363546509333010. Epub 2009 Apr 17.</citation>
    <PMID>19376939</PMID>
  </reference>
  <reference>
    <citation>Guerrero P, Li X, Patel K, Brown M, Busconi B. Medial patellofemoral ligament injury patterns and associated pathology in lateral patella dislocation: an MRI study. Sports Med Arthrosc Rehabil Ther Technol. 2009 Jul 30;1(1):17. doi: 10.1186/1758-2555-1-17.</citation>
    <PMID>19643022</PMID>
  </reference>
  <reference>
    <citation>Balcarek P, Walde TA, Frosch S, Schuttrumpf JP, Wachowski MM, Sturmer KM. MRI but not arthroscopy accurately diagnoses femoral MPFL injury in first-time patellar dislocations. Knee Surg Sports Traumatol Arthrosc. 2012 Aug;20(8):1575-80. doi: 10.1007/s00167-011-1775-7. Epub 2011 Nov 18.</citation>
    <PMID>22095485</PMID>
  </reference>
  <reference>
    <citation>Tom A, Fulkerson JP. Restoration of native medial patellofemoral ligament support after patella dislocation. Sports Med Arthrosc Rev. 2007 Jun;15(2):68-71. doi: 10.1097/JSA.0b013e31803035d3.</citation>
    <PMID>17505320</PMID>
  </reference>
  <reference>
    <citation>Camanho GL, Viegas Ade C, Bitar AC, Demange MK, Hernandez AJ. Conservative versus surgical treatment for repair of the medial patellofemoral ligament in acute dislocations of the patella. Arthroscopy. 2009 Jun;25(6):620-5. doi: 10.1016/j.arthro.2008.12.005. Epub 2009 Feb 26.</citation>
    <PMID>19501292</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>March 7, 2017</last_update_submitted>
  <last_update_submitted_qc>March 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medial patellofemoral ligament</keyword>
  <keyword>MPFL</keyword>
  <keyword>Repair</keyword>
  <keyword>Patellar dislocation</keyword>
  <keyword>Knee</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Patellar Dislocation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02185001
org study id: TLKC-0001
nct id: NCT02185001
lead sponsor: 
has dmc: No
Background: The forces involved in a patella dislocation event can cause significant
      collateral damage involving the articular cartilage of the patella femoral joint. As a
      result, prevention of recurrent patella dislocation and the associated disability and
      morbidity has generated significant interest in the orthopedic community. Historically,
      nonoperative treatment for first time patella dislocation has been problematic due to high
      redislocation rates. Nonoperative protocols generally involve bracing and/or immobilization,
      followed by physical therapy (1). Surgical approaches to recurrent patella dislocation, both
      soft tissue and boney realignment operations, have also had mixed results, including low
      success rates, associated complications, and variable rates of return to functional activity
      (2,3,4). This study is intended to compare the outcomes of a relatively low-risk Medial
      Patellofemoral Ligament (MPFL) direct repair procedure to conservative treatment.

      Methods/Design: This study is designed as a two arm randomized prospective trial.
      Approximately fifty subjects will be randomly assigned to either a surgical or non-operative
      arm by means of a computer randomized allocation program. All subjects will have X-Ray Images
      and Magnetic Resonance Imaging (MRI) to determine the site of the MPFL damage, and to
      determine if any excluding conditions exist. Subjects randomized to the surgical group will
      have repair of the MPFL. Routine aftercare will consist of physical therapy in a clinic that
      has agreed to follow our protocol. Subjects randomized to the nonoperative group will receive
      2 weeks of patellar immobilization, followed by patellar stabilization bracing with physical
      therapy for approximately 12 weeks. Physical therapy will progress through five phases with
      the goal of gait normalization, full range of motion and return to sport. Both arms will be
      given outcome questionnaires and physical activity assessments before treatment, and at one,
      three, six, twelve, and twenty four month intervals.

      Discussion: This prospective randomized trial will investigate the results of direct repair
      of the medial patellofemoral ligament and conservative treatment by applying subjective
      outcome measures (Kujala scores), and exam findings to determine MPFL functional restoration
      or redislocation. Subjects will be examined in the clinic setting at 10 days, one month, and
      six months post trauma. Any reported recurrent dislocation or subluxation event will be
      documented during recovery. All subjects will receive merchant x-ray views at 3 months with
      manual lateral translation of the patella.
Background Historic treatment for first time patella dislocation has been largely
      conservative. Treatment options include nonoperative treatment and a large variety of
      operative options. Nonoperative treatment, usually consists of bracing and/or immobilization
      followed by physical therapy, has been problematic due to a relatively high reported
      redislocation rate(1). The forces involved in a patella dislocation event can damage the
      articular cartilage of the patella femoral joint. As a result, prevention of recurrent
      patella dislocation and the associated disability and morbidity has generated significant
      interest in the orthopedic community.

      Historic surgical approaches to recurrent patella dislocation have had mixed results. The
      isolated "lateral release", has been shown to have a very low success rate(2), while
      associated complications have been appreciated. Lateral release procedures are now more often
      performed in conjunction with other proximal or distal realignment procedures(3). More
      aggressive bone realignment procedures such as tibial tubercle transfers have the
      disadvantage of reported poor long term functional recoveries and low "return to sport"
      rates(4,5).

      There has been increasing interest in ligament reconstruction for patella dislocation. The
      ligament of interest is the medial patella-femoral ligament (MPFL), which is essentially a
      thickened band of the medial capsule of the knee. The MPFL has been established as the
      primary constraint to patella dislocation. This ligament extends from a point just anterior
      to the attachment of the medial collateral ligament to the medial aspect of the patella, and
      is routinely disrupted with a patella dislocation event. The goals of reconstruction
      procedures are to replace and/or augment this band of tissue. While many reports of the
      results of MPFL reconstruction have been good to excellent, there are significant associated
      risks of complication, prolonged recovery, and associated graft costs or autograft harvest
      morbidity.

      An alternative approach to MPFL functional restoration, and the subject of this study
      proposal, is a direct repair of the MPFL. Variations of this approach have been previously
      studied. A basic understanding of established injury patterns to the MPFL is requisite to
      evaluating the limitations to these studies.

      Studies evaluating MPFL injury by MRI have shown that acute patella dislocations have a very
      high incidence of associated MPFL injury. The location of the lesion in the ligament can be
      described in one of four ways: 1) at the patellar attachment, 2) at the femoral attachment,
      3) intrasubstance portion of the ligament, or 4) a combined injury pattern. Several studies
      have demonstrated varying percent distributions of injury(6,7), but it is clear that all
      patterns exist. This conclusion is consistent with the author's experience is treating these
      injuries.

      Detecting the injury location can also be a challenge. Arthroscopic examination has been
      shown to be ineffective at determining the location of injury(8) and, in the experience of
      the author, MRI evaluation is frequently inaccurate, especially in the chronic or recurrent
      patella dislocation setting. The author proposes a functional intraoperative test to
      determine the ligament injury location.

      Some prior reports have included surgical treatment of MPFL injuries using one technique
      only, with results similar to nonoperative treatment. For instance, some studies have
      evaluated treating all patella dislocations with repair at the patellar insertion, a
      treatment which may have limited or no benefit for patients with injuries at the femoral
      attachment of the ligament. There are two limited reports evaluating somewhat similar
      techniques, and these reports indicate some of the best results in the literature in the
      management of patella-femoral instability (9,10). These results are consistent with the
      author's experience with the treatment of this condition.

      The subject of this study is to determine the difference in nonoperative and surgical patient
      outcomes using contemporary surgical techniques; identifying the location of the injury and
      choosing either direct repair or appropriate advancement. We hypothesize that minimally
      invasive surgical repair of the MPFL will improve patient outcomes and minimize recurrent
      patellar dislocation, when compared to conservative treatment. Our null hypothesis is that
      there will be no difference in outcomes between the two groups.

      Methods/Design Trial Design - The study design will be a prospective parallel-group,
      randomized trial with allocation concealment.

      Participants - At least 50 subjects will be recruited by referral from primary care
      providers, specialists, urgent care and emergency departments, and physical therapy clinics
      within a 50 mile radius of the clinic. Men, women, and minors, aged 10-17 will be recruited.

      Inclusion criteria:

        -  A first patellofemoral traumatic dislocation

        -  A need for reduction

        -  An absence of fractures on x-ray exam of the frontal and lateral knee and axial patella

        -  An absence of knee ligament lesions with surgical indications (with the exception of the
           MPFL)

        -  No previous knee surgery

      Exclusion criteria:

        -  A prior episode of patellofemoral dislocation

        -  Fractures on x-ray exam of the frontal and lateral knee and axial patella Prior surgery
           on the knee

        -  Tibial tuberosity-trochlear groove distance greater than 20mm

        -  Current pregnancy or plan to become pregnant during the study period. Recruitment - The
           recruitment process will consist of two phases. Phase one will consist of a short
           screening questionnaire, and phase two will consist of a clinical examination and
           questionnaire. Recruitment will remain open until at least fifty subjects that meet the
           inclusion criteria agree to participate.

      Randomization - After screening and accepting subjects in the recruiting process, subjects
      will be randomly assigned to either an operative group or non-operative group by means of
      computer randomized sequencing and blind allocation. Random sequence generation will be done
      by using Random Allocation Software 1.0.0., and allocation will be concealed by placing
      allocations in sequentially numbered, sealed envelopes. Randomization, allocation, and
      concealment will be accomplished by an administrative assistant with no interest in the study
      or its outcome.

      Interventions - All subjects will be briefed on their respective treatment protocols. The
      operative group will be advised on the risks of this surgery, including the chance of
      recurrent dislocations, as well as the more general risks of infection, DVT/PE, anesthesia
      complications, and associated possible complications (Table 1.1). The non-operative group
      will be advised of the possible failure of treatment, possibility of recurrent dislocation,
      and the possible need for surgery (Table 1.2).

      All subjects will receive long standing and sunrise x-rays for diagnostic purposes. An MRI
      will be obtained for identifying the site of the lesion for both groups. Additionally, we
      will ask the subjects to complete a Kujala Scoring questionnaire and physical activity
      assessment as a baseline measurement, with the intention of evaluating and subjectively
      comparing the two types of treatment. Treatment for the surgical group will be performed at
      an outpatient surgical facility, and the non-operative group will receive treatment at a
      physical therapy clinic of their choice.

      Surgical Treatment Group - Subjects who are randomized to the surgical group treatment will
      undergo surgical repair of their medial patellofemoral ligament. This will be identified
      using an MRI scan for the site of the lesion. If this cannot be identified, the following
      process will be used to determine the site of the lesion: On physical examination, the point
      of maximal tenderness between the patella and the femur will be identified and that will be
      the assumed site of traumatic injury to the medial patellofemoral ligament.

      Surgery will be performed initially with a diagnostic arthroscopy to evaluate for loose
      bodies or chondral damage anywhere in the patellofemoral joint. A video will be taken of this
      and provided to the patient postoperatively. If there are no loose bodies or chondral damage
      to be treated, the medial patellofemoral ligament will then be repaired.

      An incision will be made approximately 2 cm in length over the assumed site of the injury.
      The medial patellofemoral ligament will be identified and a tag suture will be applied to it.
      Traction on the medial patellofemoral ligament at this location will confirm that this is the
      site of primary injury by determining whether there is a firm endpoint with traction. If
      there is not a firm endpoint, a secondary incision over the alternate location, either the
      patella or the femur, will be made and the medial patellofemoral ligament will be identified
      in that location.

      Repairs of the medial patellofemoral ligament will be made at all sites opened surgically
      whether it be either the femur or the patella, or both. Surgical repair will consist of
      providing decortication of the bone at the anatomic location of the medial patellofemoral
      ligament. Placement of a single 5 mm metal suture anchor with FiberWire-type sutures and a
      repair of the medial patellofemoral ligament using the FiberWire sutures to dock the ligament
      into its anatomic location. The repairs will be then be oversewn with #1 Vicryl suture at the
      site of the repair.

      Following this, the local anesthetic will be applied to the incisions. They will be copiously
      irrigated and repaired with absorbable sutures.

      The subjects will be placed in a hinged knee brace postoperatively with a range of motion
      restriction of 0-45 degrees. Weight bearing will be allowed immediately following surgery.

      The subjects will start physical therapy the week of surgery and will begin with quadriceps
      strengthening with a restriction of range of motion from 0-45 for the first four weeks
      postoperatively followed by unrestricted full range of motion after week six. Full sport
      activities will be allowed to be resumed after eight weeks, provided the patient have at
      least 85% of the strength in their quadriceps compared to the contralateral side. Actual
      progression will be individualized based upon the patient's weekly reassessment and the
      presence of any complications.

      Postoperative follow-ups will be made at the below-mentioned intervals with appropriate
      Kujala scoring and physical activity assessment (Table 2). X-rays will be taken on the first
      postoperative visit to confirm location of suture anchor repairs.

      Appointments for physical examinations will be made at 7-10 days, 1 month, and three months
      after surgery. Any reported recurrent dislocation or subluxation event will be documented
      during recovery. All subjects will receive sunrise x-ray views at 3 months with manual
      lateral translation of the patella, as part of the study.

      Conservative Treatment Group - The conservative treatment protocol is based on accepted
      physical therapy models of care and is established relative to patient tolerance for tissue
      healing, recovery, and response to modalities and procedures. Actual progression will be
      individualized based upon the patient's weekly reassessment and the presence of any
      complications. Prevention and minimization of recurrent dislocation, painful subluxation and
      osteoarthrosis are paramount in early management scenarios. The post traumatic and post
      surgical sequelae of pain, inflammation, swelling, bruising and muscular deactivation will be
      managed with acceptable standards of practice and prescribed medications. Prevention and
      dissipation of these sequelae, including modifying activities that put excessive stress or
      loading on the patellofemoral joint are the initial goals of rehabilitation in concert with
      gradual progression of mobility and muscular reactivation techniques. The protocol is divided
      into five phases: Phase I and II, 0-4 weeks; Phase III, 5-8 weeks; Phase IV- 9-12 weeks,
      Phase V- 13+ weeks (Table 3).

      In addition to physical therapy appointments, subjects in the conservative treatment group
      will be given physical examination appointments and Kujala outcome scoring questionnaires and
      physical activity assessments at the same intervals as the surgical intervention group (Table
      2). All subjects will receive sunrise x-ray views at 3 months with manual lateral translation
      of the patella, as part of the study.

      Blinding-Due to the nature of the study, blinding of subjects after assignment to treatment
      groups is not feasible. All records and data will be collected and securely stored in the
      Clinical Research Coordinator's office. The data will be blinded before final statistical
      analysis by an independent statistician.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient Reported Change in Patellar Stability, Subluxation, or Recurrent Dislocation.
time frame: 24 months, or as reported by subject
description: Subjects will be divided into 3 groups relating to patellar stability:
Recurrence, indicating that the patient had a recurrent patellofemoral dislocation (total loss of congruence between the patella and trochlea) prior to 24 months.
Unstable, indicating that the patient's knee presented with a positive apprehension test or showed signs of subluxation prior to 24 months, but without recurrent dislocation.
Stable, indicating that the patient's knee did not show positive signs of episodes of subluxation at 24 months.
measure: Subjective Outcome Measurement (Kujala Test)
time frame: 1, 3, 6, 12, and 24 months
description: Patients will be asked to complete the Kujala knee pain questionnaire to record pain and function levels at various points in the study.
arm group label: Surgical Treatment Group
arm group type: Active Comparator
description: Direct Medial Patellofemoral Ligament (MPFL) Repair
arm group label: Conservative Treatment Group
arm group type: Active Comparator
description: Immobilization, stabilization bracing, and physical therapy
intervention type: Procedure
intervention name: Direct Medial Patellofemoral Ligament (MPFL) Repair
description: The MPFL will be repaired directly at the site of the traumatic injury.
arm group label: Surgical Treatment Group
other name: Surgical Treatment Group
intervention type: Procedure
intervention name: Physical therapy
description: Patellar immobilization, stabilization, and strengthening under the direction and guidance of the physician and physical therapist.
arm group label: Conservative Treatment Group
other name: Physiotherapy
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey R Lyman, MD
role: Principal Investigator
affiliation: Orthopedic Specialty Institute
facility: 
country: United States
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PMID: 19376939
citation: Guerrero P, Li X, Patel K, Brown M, Busconi B. Medial patellofemoral ligament injury patterns and associated pathology in lateral patella dislocation: an MRI study. Sports Med Arthrosc Rehabil Ther Technol. 2009 Jul 30;1(1):17. doi: 10.1186/1758-2555-1-17.
PMID: 19643022
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PMID: 22095485
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PMID: 17505320
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PMID: 19501292
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Patellar Dislocation
sharing ipd: Undecided