Hip Injuries
Conditions
Keywords
Capsular Repair, FAI, Hip
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.
Interventions
PROCEDURECapsular Repair
PROCEDURENo Capsular Repair
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 51 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in iHOT Version 12 | Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Marx activity score | Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years | — |
| Change in Range of Motion | Baseline, 14days, 6weeks, 12weeks, 6months, 1Year, 2Years | — |
| Change in X-rays | 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 | 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. |
Outcome results
None listed