<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/NCT03841500</url>
  </required_header>
  <id_info>
    <org_study_id>SAIRB-14-0044</org_study_id>
    <nct_id>NCT03841500</nct_id>
  </id_info>
  <brief_title>Prospective Evaluation of Osseous Integration in ACL Reconstruction Comparing Tightrope vs Interference Screw Fixation</brief_title>
  <official_title>Prospective Evaluation of Osseous Integration and Patient Outcomes In Allograft ACL Reconstruction Comparing Tightrope Versus Biocomposite Interference Screw Fixation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kelsey-Seybold Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kelsey-Seybold Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of our study was to compare osseous integration of the bone block in Achilles&#xD;
      tendon allograft ACL reconstruction using a cortical button versus biocomposite interference&#xD;
      screw fixation. The primary outcome was bone block incorporation within the femoral tunnel at&#xD;
      six months. Our null hypothesis was that there is no difference in osseous incorporation or&#xD;
      outcome with either type of femoral fixation in primary ACL reconstruction with Achilles&#xD;
      tendon allograft. Our secondary outcomes were pain and clinical outcome scores between the&#xD;
      two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining institutional review board approval the investigators conducted this&#xD;
      prospective randomized controlled trial with goal of 1:1 allocation ratio between the two&#xD;
      study groups. All subjects were recruited at the preoperative appointments. The senior&#xD;
      investigator discussed ACL reconstruction with the patients. Appropriate preoperative&#xD;
      counseling was performed regarding graft options. If inclusion criteria were met, patients&#xD;
      received information about the study. Informed consent was obtained from those choosing to&#xD;
      enroll in the study including consent for a CT scan at the six month postoperative time&#xD;
      period. The patients were randomized for fixation technique on the day of surgery from a list&#xD;
      using the medical record number. Patients underwent ACL reconstruction with Achilles tendon&#xD;
      allograft with femoral-sided bone block fixation with either (1) a biocomposite interference&#xD;
      screw (aperture fixation) or (2) cortical button (suspensory fixation).&#xD;
&#xD;
      The inclusion criteria included patients between the ages of 18 and 50 able to provide&#xD;
      informed consent with ACL tears meeting the indications for reconstruction and electing to&#xD;
      undergo reconstruction with an Achilles tendon allograft. Excluded patients included those&#xD;
      with a history of prior ACL reconstruction, pregnancy, inflammatory disease, a primary bone&#xD;
      disorder, those taking bone resorption inhibitor medications, and those with injuries to the&#xD;
      collateral ligaments or posterior cruciate ligament.&#xD;
&#xD;
      All surgeries were performed by a single surgeon at a single institution using the same&#xD;
      technique. Initial diagnosis of ACL deficiency was made on physical exam and magnetic&#xD;
      resonance imaging. This was confirmed with arthroscopy at the beginning of the case. The&#xD;
      Achilles-calcaneal bone allograft was thawed. The tendinous portion was tubularized and&#xD;
      whip-stitched with a locking Fiberloop suture (Arthrex, North Naples, FL, USA). Sutures were&#xD;
      passed through the bone block and the graft diameter was measured. The graft was then&#xD;
      pre-tensioned. Femoral tunnels were made using the anteromedial portal at 120 degrees of knee&#xD;
      flexion. The tibial tunnel was created using an outside-in technique over a pin centered at&#xD;
      the ACL footprint. In the aperture fixation group, the bone graft end was pulled through into&#xD;
      the femoral tunnel and secured with a biocomposite interference screw (BioComposite Screw,&#xD;
      Arthrex, North Naples, FL; or MILAGRO screw, DePuy Mitek, Raynham, MA, USA). In the&#xD;
      suspensory fixation group, a cortical button (TightRope, Arthrex, North Naples, FL, USA) was&#xD;
      pulled through the femoral cortex and used to shuttle the Achilles bone plug into the femoral&#xD;
      tunnel until it was just recessed within the medial intercondylar surface. In both groups,&#xD;
      tibial fixation was identical with a bioabsorbable interference screw (BioComposite Screw,&#xD;
      Arthrex, North Naples, FL, USA or Milagro screw) and a backup knotless anchor (4.5 mm Biomet&#xD;
      Peek knotless anchor, Biomet, Warsaw, IN, USA). The graft was fixed at near full extension&#xD;
      after having cycled the knee through range of motion with the graft tensioned.&#xD;
&#xD;
      All patients underwent a specified ACL post-operative rehabilitation protocol depending on&#xD;
      concomitant pathology. Cycling was permitted at the six-week mark. In-line jogging typically&#xD;
      was allowed at four months with initiation of pivoting motions at seven to eight months. Full&#xD;
      return to sports was allowed after nine months. Younger patients enrolled in a sports metrics&#xD;
      program followed by a functional ACL exam prior to return to sports. A commuted tomography&#xD;
      (CT) scan of the operative knee was obtained postoperatively at six months.&#xD;
&#xD;
      Demographic data including age, gender, and body mass index were collected. The primary&#xD;
      outcome measure was bony incorporation of the bone block within the femoral tunnel with CT&#xD;
      scan. This was assessed with the femoral ossification score as determined by three board&#xD;
      certified radiologists.&#xD;
&#xD;
      The femoral ossification score was devised as a practical means of semi-quantitatively&#xD;
      assessing the degree of bone incorporation around the femoral bone plug or screw fixation&#xD;
      device present in each patient.&#xD;
&#xD;
      Each CT scan score assessment was performed by one of three musculoskeletal&#xD;
      fellowship-trained radiologists. Whenever an ossification score was deemed to be borderline&#xD;
      between two categories, a consensus score was determined by two of the radiologists. The&#xD;
      impression in the CT report included the femoral ossification score as well as a footnote&#xD;
      with the entire scale to explain the score.&#xD;
&#xD;
      Secondary outcome measures included pain score on a visual analogue scale (VAS) obtained&#xD;
      preoperatively, at the first post-operative visit, and at return to sports. Physical&#xD;
      examination findings included range of motion (ROM) and Lachman grading which were measured&#xD;
      preoperatively and at return to sporting activities. Finally, the International Knee&#xD;
      Documentation Committee (IKDC) subjective knee evaluation score, Tegner-Lysholm Knee score,&#xD;
      and Cincinnati Knee Rating system scores were assessed both pre-operatively and&#xD;
      post-operatively at return to sports.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Femoral Ossification Score</measure>
    <time_frame>6 months post-op</time_frame>
    <description>Amount of ossification (osseous integration) around the graft at 6 months post-operatively as seen on CT scan. Score range: 0 (minimum) - 5 (maximum). Score of 0 is the worst outcome and indicates no ossification in the femoral tunnel as seen on CT scan. Score of 5 indicates full ossification of the tunnel (best outcome) as seen on CT scan. Scores in between indicate partial ossification (each number 20% more ossification than the previous score).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain (VAS)</measure>
    <time_frame>Obtained preoperatively (right before surgery); 2 weeks after surgery; and 6 months after surgery</time_frame>
    <description>Pain as assessed by the visual analog scale. Scale of 0-10 (0 is the best [no pain], 10 is the worst [severe pain])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee range of motion</measure>
    <time_frame>Obtained preoperatively (right before surgery) and at 6 months after surgery</time_frame>
    <description>Knee range of motion (measured in degrees [angle] from full extension to full flexion). 0 degrees is considered full extension. 140 degrees is full flexion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Knee Documentation Committee (IKDC) subjective knee score</measure>
    <time_frame>Obtained preoperatively (right before surgery) and at 6 months after surgery</time_frame>
    <description>The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>ACL - Anterior Cruciate Ligament Rupture</condition>
  <arm_group>
    <arm_group_label>Aperture (biocomposite screw) fixation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>16 patients in this arm underwent ACL reconstruction with the allograft fixed in the femoral tunnel with a biocomposite interference screw (BioComposite Screw, Arthrex, North Naples, FL; or MILAGRO screw, DePuy Mitek, Raynham, MA, USA).&#xD;
Intervention: ACL reconstruction with the allograft fixed in the femoral tunnel with a biocomposite interference screw.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suspensory (endobutton) fixation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>17 patients in this arm underwent ACL reconstruction with the allograft secured in the femoral tunnel with a cortical button (TightRope, Arthrex, North Naples, FL, USA).&#xD;
Intervention: ACL reconstruction with the allograft secured in the femoral tunnel with a cortical button.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biocomposite intereference screw femoral tunnel fixation</intervention_name>
    <description>ACL reconstruction using biocomposite intereference screw for femoral tunnel fixation</description>
    <arm_group_label>Aperture (biocomposite screw) fixation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endobutton (Tightrope) femoral tunnel fixation</intervention_name>
    <description>ACL reconstruction using endobutton (Tightrope) for femoral tunnel fixation</description>
    <arm_group_label>Suspensory (endobutton) fixation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients between the ages of 18 and 50 able to provide informed consent with ACL tears&#xD;
             meeting the indications for reconstruction and electing to undergo reconstruction with&#xD;
             an Achilles tendon allograft.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prior ACL reconstruction&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  inflammatory disease&#xD;
&#xD;
          -  a primary bone disorder&#xD;
&#xD;
          -  those taking bone resorption inhibitor medications&#xD;
&#xD;
          -  those with injuries to the collateral ligaments or posterior cruciate ligament&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anup Shah</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kelsey-Seybold Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kelsey-Seybold Clinic</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kelsey-Seybold Clinic</investigator_affiliation>
    <investigator_full_name>Anup Shah</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Primary and secondary outcome measures (de-identified)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data is already available (study has been completed)</ipd_time_frame>
    <ipd_access_criteria>Standard</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>March 10, 2019</submitted>
    <returned>April 1, 2019</returned>
  </pending_results>
  <!-- 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/NCT03841500
org study id: SAIRB-14-0044
nct id: NCT03841500
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of our study was to compare osseous integration of the bone block in Achilles
      tendon allograft ACL reconstruction using a cortical button versus biocomposite interference
      screw fixation. The primary outcome was bone block incorporation within the femoral tunnel at
      six months. Our null hypothesis was that there is no difference in osseous incorporation or
      outcome with either type of femoral fixation in primary ACL reconstruction with Achilles
      tendon allograft. Our secondary outcomes were pain and clinical outcome scores between the
      two groups.
After obtaining institutional review board approval the investigators conducted this
      prospective randomized controlled trial with goal of 1:1 allocation ratio between the two
      study groups. All subjects were recruited at the preoperative appointments. The senior
      investigator discussed ACL reconstruction with the patients. Appropriate preoperative
      counseling was performed regarding graft options. If inclusion criteria were met, patients
      received information about the study. Informed consent was obtained from those choosing to
      enroll in the study including consent for a CT scan at the six month postoperative time
      period. The patients were randomized for fixation technique on the day of surgery from a list
      using the medical record number. Patients underwent ACL reconstruction with Achilles tendon
      allograft with femoral-sided bone block fixation with either (1) a biocomposite interference
      screw (aperture fixation) or (2) cortical button (suspensory fixation).

      The inclusion criteria included patients between the ages of 18 and 50 able to provide
      informed consent with ACL tears meeting the indications for reconstruction and electing to
      undergo reconstruction with an Achilles tendon allograft. Excluded patients included those
      with a history of prior ACL reconstruction, pregnancy, inflammatory disease, a primary bone
      disorder, those taking bone resorption inhibitor medications, and those with injuries to the
      collateral ligaments or posterior cruciate ligament.

      All surgeries were performed by a single surgeon at a single institution using the same
      technique. Initial diagnosis of ACL deficiency was made on physical exam and magnetic
      resonance imaging. This was confirmed with arthroscopy at the beginning of the case. The
      Achilles-calcaneal bone allograft was thawed. The tendinous portion was tubularized and
      whip-stitched with a locking Fiberloop suture (Arthrex, North Naples, FL, USA). Sutures were
      passed through the bone block and the graft diameter was measured. The graft was then
      pre-tensioned. Femoral tunnels were made using the anteromedial portal at 120 degrees of knee
      flexion. The tibial tunnel was created using an outside-in technique over a pin centered at
      the ACL footprint. In the aperture fixation group, the bone graft end was pulled through into
      the femoral tunnel and secured with a biocomposite interference screw (BioComposite Screw,
      Arthrex, North Naples, FL; or MILAGRO screw, DePuy Mitek, Raynham, MA, USA). In the
      suspensory fixation group, a cortical button (TightRope, Arthrex, North Naples, FL, USA) was
      pulled through the femoral cortex and used to shuttle the Achilles bone plug into the femoral
      tunnel until it was just recessed within the medial intercondylar surface. In both groups,
      tibial fixation was identical with a bioabsorbable interference screw (BioComposite Screw,
      Arthrex, North Naples, FL, USA or Milagro screw) and a backup knotless anchor (4.5 mm Biomet
      Peek knotless anchor, Biomet, Warsaw, IN, USA). The graft was fixed at near full extension
      after having cycled the knee through range of motion with the graft tensioned.

      All patients underwent a specified ACL post-operative rehabilitation protocol depending on
      concomitant pathology. Cycling was permitted at the six-week mark. In-line jogging typically
      was allowed at four months with initiation of pivoting motions at seven to eight months. Full
      return to sports was allowed after nine months. Younger patients enrolled in a sports metrics
      program followed by a functional ACL exam prior to return to sports. A commuted tomography
      (CT) scan of the operative knee was obtained postoperatively at six months.

      Demographic data including age, gender, and body mass index were collected. The primary
      outcome measure was bony incorporation of the bone block within the femoral tunnel with CT
      scan. This was assessed with the femoral ossification score as determined by three board
      certified radiologists.

      The femoral ossification score was devised as a practical means of semi-quantitatively
      assessing the degree of bone incorporation around the femoral bone plug or screw fixation
      device present in each patient.

      Each CT scan score assessment was performed by one of three musculoskeletal
      fellowship-trained radiologists. Whenever an ossification score was deemed to be borderline
      between two categories, a consensus score was determined by two of the radiologists. The
      impression in the CT report included the femoral ossification score as well as a footnote
      with the entire scale to explain the score.

      Secondary outcome measures included pain score on a visual analogue scale (VAS) obtained
      preoperatively, at the first post-operative visit, and at return to sports. Physical
      examination findings included range of motion (ROM) and Lachman grading which were measured
      preoperatively and at return to sporting activities. Finally, the International Knee
      Documentation Committee (IKDC) subjective knee evaluation score, Tegner-Lysholm Knee score,
      and Cincinnati Knee Rating system scores were assessed both pre-operatively and
      post-operatively at return to sports.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Femoral Ossification Score
time frame: 6 months post-op
description: Amount of ossification (osseous integration) around the graft at 6 months post-operatively as seen on CT scan. Score range: 0 (minimum) - 5 (maximum). Score of 0 is the worst outcome and indicates no ossification in the femoral tunnel as seen on CT scan. Score of 5 indicates full ossification of the tunnel (best outcome) as seen on CT scan. Scores in between indicate partial ossification (each number 20% more ossification than the previous score).
measure: Pain (VAS)
time frame: Obtained preoperatively (right before surgery); 2 weeks after surgery; and 6 months after surgery
description: Pain as assessed by the visual analog scale. Scale of 0-10 (0 is the best [no pain], 10 is the worst [severe pain])
measure: Knee range of motion
time frame: Obtained preoperatively (right before surgery) and at 6 months after surgery
description: Knee range of motion (measured in degrees [angle] from full extension to full flexion). 0 degrees is considered full extension. 140 degrees is full flexion.
measure: International Knee Documentation Committee (IKDC) subjective knee score
time frame: Obtained preoperatively (right before surgery) and at 6 months after surgery
description: The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
arm group label: Aperture (biocomposite screw) fixation
arm group type: Active Comparator
description: 16 patients in this arm underwent ACL reconstruction with the allograft fixed in the femoral tunnel with a biocomposite interference screw (BioComposite Screw, Arthrex, North Naples, FL; or MILAGRO screw, DePuy Mitek, Raynham, MA, USA).
Intervention: ACL reconstruction with the allograft fixed in the femoral tunnel with a biocomposite interference screw.
arm group label: Suspensory (endobutton) fixation
arm group type: Active Comparator
description: 17 patients in this arm underwent ACL reconstruction with the allograft secured in the femoral tunnel with a cortical button (TightRope, Arthrex, North Naples, FL, USA).
Intervention: ACL reconstruction with the allograft secured in the femoral tunnel with a cortical button.
intervention type: Device
intervention name: Biocomposite intereference screw femoral tunnel fixation
description: ACL reconstruction using biocomposite intereference screw for femoral tunnel fixation
arm group label: Aperture (biocomposite screw) fixation
intervention type: Device
intervention name: Endobutton (Tightrope) femoral tunnel fixation
description: ACL reconstruction using endobutton (Tightrope) for femoral tunnel fixation
arm group label: Suspensory (endobutton) fixation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anup Shah
role: Principal Investigator
affiliation: Kelsey-Seybold Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Kelsey-Seybold Clinic
investigator full name: Anup Shah
investigator title: Principal Investigator
mesh term: Rupture
sharing ipd: Yes
ipd description: Primary and secondary outcome measures (de-identified)
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data is already available (study has been completed)
ipd access criteria: Standard
submitted: March 10, 2019
returned: April 1, 2019