Clinical trial NCT02990234: Capsular Repair in FAI Impingement Surgery
Official title: The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Injuries
Keywords: Capsular Repair
FAI
Hip
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Maximum age (years): 51
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in iHOT Version 12
timeFrame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years
Secondary outcomes:
Other outcomes:
measure: Change in Marx activity score
timeFrame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years
measure: Change in Range of Motion
timeFrame: Baseline, 14days, 6weeks, 12weeks, 6months, 1Year, 2Years
measure: Change in X-rays
timeFrame: 6weeks, 6months, 1Year
measure: Change in MRI
timeFrame: 6weeks, 6months
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Omer Mei-Dan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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: 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: 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: 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: 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.