Capsular Repair in FAI Impingement Surgery
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|ClinicalTrials.gov Identifier: NCT02990234|
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hip Injuries||Procedure: Capsular Repair Procedure: No Capsular Repair||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Active Comparator: Capsular Repair
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.
Procedure: Capsular Repair
Placebo Comparator: No Capsular Repair
Placebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair.
Procedure: No Capsular Repair
- Change in iHOT Version 12 [ Time Frame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years ]
- Change in Marx activity score [ Time Frame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years ]
- Change in Range of Motion [ Time Frame: Baseline, 14days, 6weeks, 12weeks, 6months, 1Year, 2Years ]
- Change in X-rays [ Time Frame: 6weeks, 6months, 1Year ]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.
- Change in MRI [ Time Frame: 6weeks, 6months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990234
|Principal Investigator:||Omer Mei-Dan, MD||University of Colorado, Denver|