Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement

Femoroacetabular Impingement Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Arthroscopic Surgery to Conservative Management of Femoroacetabular Impingement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01621360
• Other study ID #: FKSMC-2011-01
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2011
• Last updated: February 6, 2013
• Start date: May 2011
• Est. completion date: May 2014

Study information

• Verified date: February 2013
• Source: University of Western Ontario, Canada
• Contact: Stacey Wanlin
• Phone: 519-661-2111
• Email: swanlin[@]uwo.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine if patients with femoroacetabular impingement (FAI) who undergo arthroscopic hip surgery experience similar outcomes at 2 years post-operative with respect to physical function, pain, and health related quality of life, compared to similar patients who receive conservative management, including medication and physiotherapy.

Description:

Arthroscopic surgery is now commonly used to treat patients with femoroacetabular impingement (FAI) however there is a lack of scientific evidence to support its efficacy. Two distinct types of FAI have been defined: cam impingement and pincer impingement. Cam impingement is described as an abnormally prominent anterolateral femoral head-neck junction that rubs against the acetabular rim during flexion resulting in impingement of the acetabular labrum. Pincer impingement is described as an anatomical overcoverage of the femoral head by the acetabulum that impinges the labrum leading to proliferation, or an increase in the prominence of the acetabular rim, further exacerbating the impingement. Previous studies investigating the efficacy of arthroscopic surgery of the knee and shoulder have shown no benefit compared to sham surgery and non-surgical management, therefore strong scientific evidence is needed to support its use in the treatment of hip pathology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with femoroacetabular impingement of the hip

• 18 years of age or older

• grade 1, 2 or 3 radiographic severity of osteoarthritis as defined by the Tonnis classification scale.

Exclusion Criteria:

• identified isolated labral tear

• inflammatory or post-infectious arthritis

• previous arthroscopic treatment for hip osteoarthritis

• previous major hip trauma

• Tönnis grade 4 osteoarthritis in two compartments in persons over 60 years of age.

• patients with a major neurologic deficit, serious medical illness (life expectancy less than 2 years or high intraoperative risk) or those who are unable to provide informed consent or who are deemed unlikely to comply with follow-up.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

Procedure:
• Arthroscopic hip surgery
Hip arthroscopy

Other:
• Physical therapy
Physical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication.

Locations

Country	Name	City	State
Canada	London Health Sciences Center, University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (16)

Anderson K, Bowen MK. Spur reformation after arthroscopic acromioplasty. Arthroscopy. 1999 Oct;15(7):788-91. — View Citation

Gerber C, Terrier F, Ganz R. The role of the coracoid process in the chronic impingement syndrome. J Bone Joint Surg Br. 1985 Nov;67(5):703-8. — View Citation

Gosvig KK, Jacobsen S, Sonne-Holm S, Gebuhr P. The prevalence of cam-type deformity of the hip joint: a survey of 4151 subjects of the Copenhagen Osteoarthritis Study. Acta Radiol. 2008 May;49(4):436-41. doi: 10.1080/02841850801935567. — View Citation

Kassarjian A, Yoon LS, Belzile E, Connolly SA, Millis MB, Palmer WE. Triad of MR arthrographic findings in patients with cam-type femoroacetabular impingement. Radiology. 2005 Aug;236(2):588-92. Epub 2005 Jun 21. — View Citation

Kim YJ, Bixby S, Mamisch TC, Clohisy JC, Carlisle JC. Imaging structural abnormalities in the hip joint: instability and impingement as a cause of osteoarthritis. Semin Musculoskelet Radiol. 2008 Dec;12(4):334-45. doi: 10.1055/s-0028-1100640. Epub 2008 Nov 18. Review. — View Citation

Kirkley A, Birmingham TB, Litchfield RB, Giffin JR, Willits KR, Wong CJ, Feagan BG, Donner A, Griffin SH, D'Ascanio LM, Pope JE, Fowler PJ. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. doi: 10.1056/NEJMoa0708333. Erratum in: N Engl J Med. 2009 Nov 12;361(20):2004. — View Citation

Liotard JP, Cochard P, Walch G. Critical analysis of the supraspinatus outlet view: rationale for a standard scapular Y-view. J Shoulder Elbow Surg. 1998 Mar-Apr;7(2):134-9. — View Citation

Martin RL, Sekiya JK. The interrater reliability of 4 clinical tests used to assess individuals with musculoskeletal hip pain. J Orthop Sports Phys Ther. 2008 Feb;38(2):71-7. doi: 10.2519/jospt.2008.2677. Epub 2007 Sep 21. — View Citation

Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. — View Citation

Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. — View Citation

Nötzli HP, Wyss TF, Stoecklin CH, Schmid MR, Treiber K, Hodler J. The contour of the femoral head-neck junction as a predictor for the risk of anterior impingement. J Bone Joint Surg Br. 2002 May;84(4):556-60. — View Citation

Peters CL, Erickson JA. Treatment of femoro-acetabular impingement with surgical dislocation and débridement in young adults. J Bone Joint Surg Am. 2006 Aug;88(8):1735-41. — View Citation

Pfirrmann CW, Mengiardi B, Dora C, Kalberer F, Zanetti M, Hodler J. Cam and pincer femoroacetabular impingement: characteristic MR arthrographic findings in 50 patients. Radiology. 2006 Sep;240(3):778-85. Epub 2006 Jul 20. Erratum in: Radiology. 2007 Aug;244(2):626. — View Citation

Reynolds D, Lucas J, Klaue K. Retroversion of the acetabulum. A cause of hip pain. J Bone Joint Surg Br. 1999 Mar;81(2):281-8. — View Citation

Thompson WO, Debski RE, Boardman ND 3rd, Taskiran E, Warner JJ, Fu FH, Woo SL. A biomechanical analysis of rotator cuff deficiency in a cadaveric model. Am J Sports Med. 1996 May-Jun;24(3):286-92. — View Citation

Wuelker N, Plitz W, Roetman B, Wirth CJ. Function of the supraspinatus muscle. Abduction of the humerus studied in cadavers. Acta Orthop Scand. 1994 Aug;65(4):442-6. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip Outcome Score (HOS)	The HOS is a disease-specific questionnaire with high reliability and internal consistency. The index has 2 subscales: Activities of Daily Living (ADL) and Sports. Items are scored from 0-4, or N/A which removes item from scoring. The highest potential score is the total number of items with a response multiplied by 4. The item score divided by the highest potential score, multiplied by 100, generates a percentage. A higher score represents a higher level of physical function. The minimal clinically important difference is 9 points for the ADL subscale and 6 points for the Sports subscale.	24 months	No
Secondary	Non-Arthritic Hip Score	The Non-Arthritic Hip Score (NAHS) is a validated disease-specific questionnaire, consisting of 20 questions, divided into four domains: Pain, Symptoms, Physical Function, and Participation. Items are scored from 0-4, and added together for an overall total score. A higher score represents a higher level of physical function and less pain and symptoms. The NAHS has demonstrated good validity and has high internal consistency.	2 weeks, and at months 3, 6, 12, 18, and 24.	No
Secondary	Modified Harris Hip Score	The Modified Harris Hip Score is a modification of the Harris Hip Score which was originally developed for use in total hip arthroplasty patients. The modified version includes only the pain and function domains (range of motion and deformity domains from original version are removed) for a total score out of 100 points, with a higher score indicating greater function and less pain.	2 weeks, and at months 3, 6, 12, 18, and 24.	No
Secondary	SF-12	The SF-12 is a 12-item generic general health instrument that evaluates eight domains including restrictions or limitations on physical and social activities, normal activities and responsibilities of daily living, pain, mental health and well-being, and perceptions of health. The SF-12 has been extensively used, and has been shown to be valid, reliable, and responsive in a wide variety of populations and contexts including patients with orthopedic conditions. It is generally accepted that the minimally important difference for the SF-12 ranges from 3-5 points.	2 weeks, and at months 3, 6, 12, 18, and 24.	No
Secondary	Range of Motion		2 weeks, and at months 3, 6, 12, 18, and 24.	No