Capsular Repair in FAI Impingement Surgery

Hip Injuries Clinical Trial

Official title:

The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990234
• Other study ID #: 13-2310
• Status: Completed
• Phase: N/A
• First received: December 5, 2016
• Last updated: November 29, 2017
• Start date: March 2014
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 51 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Injuries

Intervention

Procedure:
• Capsular Repair

• No Capsular Repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

References & Publications (8)

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. — View 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. Review. — View Citation

Byrd JW. Hip arthroscopy. J Am Acad Orthop Surg. 2006 Jul;14(7):433-44. Review. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Marx activity score		Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years
Other	Change in Range of Motion		Baseline, 14days, 6weeks, 12weeks, 6months, 1Year, 2Years
Other	Change in X-rays	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.	6weeks, 6months, 1Year
Other	Change in MRI	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.	6weeks, 6months
Primary	Change in iHOT Version 12		Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years