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Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement

Primary Purpose

Femoroacetabular Impingement

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Arthroscopic hip surgery
Physical therapy
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoroacetabular Impingement focused on measuring Randomized controlled trial, Intention to treat

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Sciences Center, University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arthroscopic surgery

Conservative management

Arm Description

Arthroscopic surgery of the hip plus optimized medical management

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Range of Motion

Full Information

First Posted
December 19, 2011
Last Updated
February 6, 2013
Sponsor
University of Western Ontario, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01621360
Brief Title
Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement
Official Title
A Randomized Controlled Trial Comparing Arthroscopic Surgery to Conservative Management of Femoroacetabular Impingement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Western Ontario, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement
Keywords
Randomized controlled trial, Intention to treat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopic surgery
Arm Type
Active Comparator
Arm Description
Arthroscopic surgery of the hip plus optimized medical management
Arm Title
Conservative management
Arm Type
Active Comparator
Arm Description
Physical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic hip surgery
Intervention Description
Hip arthroscopy
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
Physical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication.
Primary Outcome Measure Information:
Title
Hip Outcome Score (HOS)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Non-Arthritic Hip Score
Description
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.
Time Frame
2 weeks, and at months 3, 6, 12, 18, and 24.
Title
Modified Harris Hip Score
Description
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.
Time Frame
2 weeks, and at months 3, 6, 12, 18, and 24.
Title
SF-12
Description
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.
Time Frame
2 weeks, and at months 3, 6, 12, 18, and 24.
Title
Range of Motion
Time Frame
2 weeks, and at months 3, 6, 12, 18, and 24.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Wanlin
Phone
519-661-2111
Ext
80946
Email
swanlin@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Naudie, MD, FRCSC
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Center, University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2K3
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
12110735
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. doi: 10.1056/NEJMoa013259.
Results Reference
background
PubMed Identifier
18784099
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.
Results Reference
background
PubMed Identifier
5054450
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. No abstract available.
Results Reference
background
PubMed Identifier
9593091
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. doi: 10.1016/s1058-2746(98)90223-3.
Results Reference
background
PubMed Identifier
4055864
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. doi: 10.1302/0301-620X.67B5.4055864.
Results Reference
background
PubMed Identifier
10524832
Citation
Anderson K, Bowen MK. Spur reformation after arthroscopic acromioplasty. Arthroscopy. 1999 Oct;15(7):788-91. doi: 10.1016/s0749-8063(99)70018-6.
Results Reference
background
PubMed Identifier
8734877
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. doi: 10.1177/036354659602400307.
Results Reference
background
PubMed Identifier
7976295
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. doi: 10.3109/17453679408995490.
Results Reference
background
PubMed Identifier
18415788
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.
Results Reference
background
PubMed Identifier
15972331
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. doi: 10.1148/radiol.2362041987. Epub 2005 Jun 21.
Results Reference
background
PubMed Identifier
18560194
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.
Results Reference
background
PubMed Identifier
12043778
Citation
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.
Results Reference
background
PubMed Identifier
16857978
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. doi: 10.1148/radiol.2403050767. Epub 2006 Jul 20. Erratum In: Radiology. 2007 Aug;244(2):626.
Results Reference
background
PubMed Identifier
16882895
Citation
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.
Results Reference
background
PubMed Identifier
10204935
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. doi: 10.1302/0301-620x.81b2.8291.
Results Reference
background
PubMed Identifier
19016396
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.
Results Reference
background

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Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement

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