Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement

NCT ID: NCT01621360

Last Updated: 2013-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Femoroacetabular Impingement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arthroscopic surgery

Arthroscopic surgery of the hip plus optimized medical management

Group Type ACTIVE_COMPARATOR

Arthroscopic hip surgery

Intervention Type PROCEDURE

Hip arthroscopy

Conservative management

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

Group Type ACTIVE_COMPARATOR

Physical therapy

Intervention Type OTHER

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

Interventions

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Arthroscopic hip surgery

Hip arthroscopy

Intervention Type PROCEDURE

Physical therapy

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Western Ontario, Canada

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Douglas Naudie, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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London Health Sciences Center, University Hospital

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Stacey Wanlin

Role: CONTACT

519-661-2111 ext. 80946

References

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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. doi: 10.1056/NEJMoa013259.

Reference Type BACKGROUND
PMID: 12110735 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18784099 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 5054450 (View on PubMed)

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. doi: 10.1016/s1058-2746(98)90223-3.

Reference Type BACKGROUND
PMID: 9593091 (View on PubMed)

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. doi: 10.1302/0301-620X.67B5.4055864.

Reference Type BACKGROUND
PMID: 4055864 (View on PubMed)

Anderson K, Bowen MK. Spur reformation after arthroscopic acromioplasty. Arthroscopy. 1999 Oct;15(7):788-91. doi: 10.1016/s0749-8063(99)70018-6.

Reference Type BACKGROUND
PMID: 10524832 (View on PubMed)

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. doi: 10.1177/036354659602400307.

Reference Type BACKGROUND
PMID: 8734877 (View on PubMed)

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. doi: 10.3109/17453679408995490.

Reference Type BACKGROUND
PMID: 7976295 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18415788 (View on PubMed)

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. doi: 10.1148/radiol.2362041987. Epub 2005 Jun 21.

Reference Type BACKGROUND
PMID: 15972331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18560194 (View on PubMed)

Notzli 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. doi: 10.1302/0301-620x.84b4.12014.

Reference Type BACKGROUND
PMID: 12043778 (View on PubMed)

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. doi: 10.1148/radiol.2403050767. Epub 2006 Jul 20.

Reference Type BACKGROUND
PMID: 16857978 (View on PubMed)

Peters CL, Erickson JA. Treatment of femoro-acetabular impingement with surgical dislocation and debridement in young adults. J Bone Joint Surg Am. 2006 Aug;88(8):1735-41. doi: 10.2106/JBJS.E.00514.

Reference Type BACKGROUND
PMID: 16882895 (View on PubMed)

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. doi: 10.1302/0301-620x.81b2.8291.

Reference Type BACKGROUND
PMID: 10204935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19016396 (View on PubMed)

Other Identifiers

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FKSMC-2011-01

Identifier Type: -

Identifier Source: org_study_id

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