Clinical trial NCT01621360: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Femoroacetabular Impingement
Keywords: Randomized controlled trial
Intention to treat
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hip Outcome Score (HOS)
timeFrame: 24 months
Secondary outcomes:
measure: Non-Arthritic Hip Score
timeFrame: 2 weeks, and at months 3, 6, 12, 18, and 24.
measure: Modified Harris Hip Score
timeFrame: 2 weeks, and at months 3, 6, 12, 18, and 24.
measure: SF-12
timeFrame: 2 weeks, and at months 3, 6, 12, 18, and 24.
measure: Range of Motion
timeFrame: 2 weeks, and at months 3, 6, 12, 18, and 24.
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Center, University Hospital
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Douglas Naudie, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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