<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/NCT02990234</url>
  </required_header>
  <id_info>
    <org_study_id>13-2310</org_study_id>
    <nct_id>NCT02990234</nct_id>
  </id_info>
  <brief_title>Capsular Repair in FAI Impingement Surgery</brief_title>
  <official_title>The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular&#xD;
      Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient&#xD;
      outcomes in the short, mid and long term, both clinically and radiographically, compared to&#xD;
      those without capsular repair. The objective of this clinical trial is to evaluate the&#xD;
      clinical efficacy with regards to pain, range of motion and return to work and activities of&#xD;
      daily living. Secondary objective is to evaluate radiographic characteristics between both&#xD;
      groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 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>Change in iHOT Version 12</measure>
    <time_frame>Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Change in Marx activity score</measure>
    <time_frame>Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in Range of Motion</measure>
    <time_frame>Baseline, 14days, 6weeks, 12weeks, 6months, 1Year, 2Years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in X-rays</measure>
    <time_frame>6weeks, 6months, 1Year</time_frame>
    <description>XR will be used for initial evaluation and for post op resection assessment and long-term OA changes. X-rays will be done post-operatively at 6 weeks, 6 months and 1 year time-frames. All these x-rays are normally performed as standard of care.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in MRI</measure>
    <time_frame>6weeks, 6months</time_frame>
    <description>MRI will be conducted at 6 weeks and 6 months post op to evaluate capsular healing status (primary radiological outcome measure), intra articular adhesions, extra articular scarring, labrum/cartilage status and resection assessment. This MRI will be paid by department funds.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Hip Injuries</condition>
  <arm_group>
    <arm_group_label>Capsular Repair</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Capsular Repair arm. The first hip is randomized, opposite treatment on second hip. One Hip will receive the capsular repair while the other hip will not.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Capsular Repair</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Capsular Repair</intervention_name>
    <arm_group_label>Capsular Repair</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No Capsular Repair</intervention_name>
    <arm_group_label>No Capsular Repair</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients aged between 16-51 years of age.&#xD;
&#xD;
          2. Healthy patients undergoing hip arthroscopy due to Cam or mixed FAI&#xD;
&#xD;
          3. No major osteoarthritic (OA) changes according to X-Ray and surgery observation&#xD;
             (Tonnis 0-1)&#xD;
&#xD;
          4. No previous hip surgery&#xD;
&#xD;
          5. No other influential disabilities in lower limbs&#xD;
&#xD;
          6. No chronic use of NSAID, analgesics, steroids or chemotherapy drugs&#xD;
&#xD;
          7. Base line activity level (Tegner 3 and above)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with concomitant disease that may affect joints&#xD;
&#xD;
          2. Patients with major ligamentous laxity&#xD;
&#xD;
          3. Patients who have undergone only minor vertical capsulotomy (as in small pincer only&#xD;
             lesions)&#xD;
&#xD;
          4. Patients with extreme range of motion needs (such as ballet dancers)&#xD;
&#xD;
          5. Patients suffering from connective tissue disease&#xD;
&#xD;
          6. Patients suffering from bilateral symptomatic FAI that are being operated on for their&#xD;
             first hip&#xD;
&#xD;
          7. Patients with relative or proven dysplastic hip determined by center edge angle and/or&#xD;
             extreme version abnormalities as measured on apical CT/MR cuts and pelvic XR&#xD;
&#xD;
          8. Patients who needed Ilio-Psoas release&#xD;
&#xD;
          9. Patients whose cartilage hip status was defined as advanced OA during surgery&#xD;
&#xD;
         10. Patients who following surgery would be instructed to avoid full weight bearing on the&#xD;
             operated hip for more than 4 weeks&#xD;
&#xD;
         11. Concomitant use of PRP (platelet rich plasma) or hyaluronic acid during the surgical&#xD;
             procedure&#xD;
&#xD;
         12. Patients with preoperative hip stiffness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>51 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Omer Mei-Dan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <reference>
    <citation>Bowman KF Jr, Fox J, Sekiya JK. A clinically relevant review of hip biomechanics. Arthroscopy. 2010 Aug;26(8):1118-29. doi: 10.1016/j.arthro.2010.01.027.</citation>
    <PMID>20678712</PMID>
  </reference>
  <reference>
    <citation>Byrd JW. Hip arthroscopy. J Am Acad Orthop Surg. 2006 Jul;14(7):433-44. doi: 10.5435/00124635-200607000-00006. No abstract available.</citation>
    <PMID>16822891</PMID>
  </reference>
  <reference>
    <citation>Philippon MJ, Schenker ML. Arthroscopy for the treatment of femoroacetabular impingement in the athlete. Clin Sports Med. 2006 Apr;25(2):299-308, ix. doi: 10.1016/j.csm.2005.12.006.</citation>
    <PMID>16638493</PMID>
  </reference>
  <reference>
    <citation>Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013.</citation>
    <PMID>16376242</PMID>
  </reference>
  <reference>
    <citation>Ranawat AS, McClincy M, Sekiya JK. Anterior dislocation of the hip after arthroscopy in a patient with capsular laxity of the hip. A case report. J Bone Joint Surg Am. 2009 Jan;91(1):192-7. doi: 10.2106/JBJS.G.01367. No abstract available.</citation>
    <PMID>19122095</PMID>
  </reference>
  <reference>
    <citation>Matsuda DK. Acute iatrogenic dislocation following hip impingement arthroscopic surgery. Arthroscopy. 2009 Apr;25(4):400-4. doi: 10.1016/j.arthro.2008.12.011. Epub 2009 Feb 1.</citation>
    <PMID>19341927</PMID>
  </reference>
  <reference>
    <citation>Benali Y, Katthagen BD. Hip subluxation as a complication of arthroscopic debridement. Arthroscopy. 2009 Apr;25(4):405-7. doi: 10.1016/j.arthro.2009.01.012.</citation>
    <PMID>19341928</PMID>
  </reference>
  <reference>
    <citation>Ilizaliturri VM Jr, Byrd JW, Sampson TG, Guanche CA, Philippon MJ, Kelly BT, Dienst M, Mardones R, Shonnard P, Larson CM. A geographic zone method to describe intra-articular pathology in hip arthroscopy: cadaveric study and preliminary report. Arthroscopy. 2008 May;24(5):534-9. doi: 10.1016/j.arthro.2007.11.019. Epub 2008 Feb 1.</citation>
    <PMID>18442685</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>November 29, 2017</last_update_submitted>
  <last_update_submitted_qc>November 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Capsular Repair</keyword>
  <keyword>FAI</keyword>
  <keyword>Hip</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02990234
org study id: 13-2310
nct id: NCT02990234
lead sponsor: 
has dmc: No
The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular
      Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient
      outcomes in the short, mid and long term, both clinically and radiographically, compared to
      those without capsular repair. The objective of this clinical trial is to evaluate the
      clinical efficacy with regards to pain, range of motion and return to work and activities of
      daily living. Secondary objective is to evaluate radiographic characteristics between both
      groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in iHOT Version 12
time frame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years
measure: Change in Marx activity score
time frame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years
measure: Change in Range of Motion
time frame: Baseline, 14days, 6weeks, 12weeks, 6months, 1Year, 2Years
measure: Change in X-rays
time frame: 6weeks, 6months, 1Year
description: XR will be used for initial evaluation and for post op resection assessment and long-term OA changes. X-rays will be done post-operatively at 6 weeks, 6 months and 1 year time-frames. All these x-rays are normally performed as standard of care.
measure: Change in MRI
time frame: 6weeks, 6months
description: MRI will be conducted at 6 weeks and 6 months post op to evaluate capsular healing status (primary radiological outcome measure), intra articular adhesions, extra articular scarring, labrum/cartilage status and resection assessment. This MRI will be paid by department funds.
arm group label: Capsular Repair
arm group type: Active Comparator
description: Capsular Repair arm. The first hip is randomized, opposite treatment on second hip. One Hip will receive the capsular repair while the other hip will not.
arm group label: No Capsular Repair
arm group type: Placebo Comparator
description: Placebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair.
intervention type: Procedure
intervention name: Capsular Repair
arm group label: Capsular Repair
intervention type: Procedure
intervention name: No Capsular Repair
arm group label: No Capsular Repair
criteria: 
gender: All
minimum age: 16 Years
maximum age: 51 Years
healthy volunteers: No
last name: Omer Mei-Dan, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
citation: Bowman KF Jr, Fox J, Sekiya JK. A clinically relevant review of hip biomechanics. Arthroscopy. 2010 Aug;26(8):1118-29. doi: 10.1016/j.arthro.2010.01.027.
PMID: 20678712
citation: Byrd JW. Hip arthroscopy. J Am Acad Orthop Surg. 2006 Jul;14(7):433-44. doi: 10.5435/00124635-200607000-00006. No abstract available.
PMID: 16822891
citation: Philippon MJ, Schenker ML. Arthroscopy for the treatment of femoroacetabular impingement in the athlete. Clin Sports Med. 2006 Apr;25(2):299-308, ix. doi: 10.1016/j.csm.2005.12.006.
PMID: 16638493
citation: Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013.
PMID: 16376242
citation: Ranawat AS, McClincy M, Sekiya JK. Anterior dislocation of the hip after arthroscopy in a patient with capsular laxity of the hip. A case report. J Bone Joint Surg Am. 2009 Jan;91(1):192-7. doi: 10.2106/JBJS.G.01367. No abstract available.
PMID: 19122095
citation: Matsuda DK. Acute iatrogenic dislocation following hip impingement arthroscopic surgery. Arthroscopy. 2009 Apr;25(4):400-4. doi: 10.1016/j.arthro.2008.12.011. Epub 2009 Feb 1.
PMID: 19341927
citation: Benali Y, Katthagen BD. Hip subluxation as a complication of arthroscopic debridement. Arthroscopy. 2009 Apr;25(4):405-7. doi: 10.1016/j.arthro.2009.01.012.
PMID: 19341928
citation: Ilizaliturri VM Jr, Byrd JW, Sampson TG, Guanche CA, Philippon MJ, Kelly BT, Dienst M, Mardones R, Shonnard P, Larson CM. A geographic zone method to describe intra-articular pathology in hip arthroscopy: cadaveric study and preliminary report. Arthroscopy. 2008 May;24(5):534-9. doi: 10.1016/j.arthro.2007.11.019. Epub 2008 Feb 1.
PMID: 18442685
responsible party type: Sponsor
mesh term: Hip Injuries
sharing ipd: No