Capsular Repair in FAI Impingement Surgery

Not Applicable

Completed

• Conditions: Hip Injuries
• Interventions: Procedure: Capsular Repair; Procedure: No Capsular Repair

• Registration Number: NCT02990234
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-13
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-29
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Male or female patients aged between 16-51 years of age.
2. Healthy patients undergoing hip arthroscopy due to Cam or mixed FAI
3. No major osteoarthritic (OA) changes according to X-Ray and surgery observation (Tonnis 0-1)
4. No previous hip surgery
5. No other influential disabilities in lower limbs
6. No chronic use of NSAID, analgesics, steroids or chemotherapy drugs
7. Base line activity level (Tegner 3 and above)

Exclusion Criteria

1. Patients with concomitant disease that may affect joints
2. Patients with major ligamentous laxity
3. Patients who have undergone only minor vertical capsulotomy (as in small pincer only lesions)
4. Patients with extreme range of motion needs (such as ballet dancers)
5. Patients suffering from connective tissue disease
6. Patients suffering from bilateral symptomatic FAI that are being operated on for their first hip
7. Patients with relative or proven dysplastic hip determined by center edge angle and/or extreme version abnormalities as measured on apical CT/MR cuts and pelvic XR
8. Patients who needed Ilio-Psoas release
9. Patients whose cartilage hip status was defined as advanced OA during surgery
10. Patients who following surgery would be instructed to avoid full weight bearing on the operated hip for more than 4 weeks
11. Concomitant use of PRP (platelet rich plasma) or hyaluronic acid during the surgical procedure
12. Patients with preoperative hip stiffness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capsular Repair	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.
No Capsular Repair	No Capsular Repair	Placebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair.

Primary Outcome Measures

Name	Time	Method
Change in iHOT Version 12	Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years