Femoroacetabular Impingement RandomiSed Controlled Trial

McMaster University220 enrolled

Overview

The purpose of this study is to determine whether surgical correction of hip impingement morphology via arthroscopic osteochondroplasty (shaving of bone) will provide improved clinical results (decreased pain and improved function) in adult patients with femoroacetabular impingement (FAI) compared to arthroscopic lavage (washing out of painful inflammation debris) and treating obvious damage of the hip joint.

Femoroacetabular impingement (FAI) is a condition of the hip where there is a mismatch of the ball and socket in the hip joint. This mismatch creates abnormal contact in the hip which can cause patients to experience hip pain. This can eventually lead to hip damage and osteoarthritis. Hip arthroscopy, a form of minimally invasive surgery has become a popular treatment option. The investigators are conducting a definitive randomized controlled trial (RCT) to determine whether surgical correction of the impingement morphology via arthroscopic osteochondroplasty (shaving of bone) will provide improved clinical results (decreased pain and improved function) in adult FAI patients compared to arthroscopic lavage (washing out of painful inflammation debris) and treating obvious damage of the hip joint. Like most RCTs, FIRST is designed to demonstrate efficacy (i.e. that an intervention can work theoretically under optimal conditions). In order to address generalizability and improve external validity of the FIRST trial, we are including an external validation cohort using a "RCT with and Embedded ProspectIve Cohort design" (FIRST-EPIC). This pragmatic cohort will allow us to: 1) safeguard against bias attributable to patients declining to take part in the RCT; 2) corroborate or refute whether our efficacy (RCT) population represents the best case scenario (i.e. those with optimal response to osteochondroplasty); 3) evaluate effectiveness of osteochondroplasty and other standard of care treatments for FAI in patients with potentially distinct prognostic factors; and 4) evaluate the cost-effectiveness of the interventions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

220

Conditions

Femoroacetabular Impingement

Interventions

Arthroscopic LavagePROCEDURE

Lavage: inflammation debris caused from continual friction in the hip is washed out.

Arthroscopic OsteochondroplastyPROCEDURE

Osteochondroplasty: reshaping the hip ball and socket ("osteoplasty" or "rim trimming").

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult men or women ages 18 to 50 years 2. Hip pain for greater than 6 months with no relief from non-operative means (physiotherapy, non-steroidal anti-inflammatory medication, rest) 3. Documentation of failed physiotherapy, including core conditioning of the hip, back, and abdomen 4. CAM or Mixed Type FAI as diagnosed on x-rays and magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA) 5. Temporary relief from an intra-articular hip injection 6. Informed consent from participant 7. Ability to speak, understand and read in the language of the clinical site Exclusion Criteria: 1. Previous inclusion in a study involving FAI 2. Evidence of hip dysplasia (centre edge angle less than 20) 3. Presence of advanced hip osteoarthritis (Tonnis Grade 2 or 3) 4. Presence of other hip syndromes (concurrent non-FAI related pathology) 5. Previous trauma to the affected hip 6. Previous surgery on the affected hip or contralateral hip 7. Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda, circumferential labral ossification) 8. Immunosuppressive medication use 9. Chronic pain syndromes 10. Significant medical co-morbidities (requiring daily assistance for ADLs) 11. History of paediatric hip disease (Legg-Calve-Perthes; slipped capital femoral epiphysis) 12. Ongoing litigation or compensation claims secondary to hip problems 13. Any other reasons given to exclude the patient * If a patient does not meet the eligibility criteria for the FIRST trial, they may be considered eligible for the FIRST-EPIC sub-study.

Locations (10)

Dalhousie University

Halifax, Nova Scotia, Canada

McMaster University

Hamilton, Ontario, Canada

Kingston General Hospital

Kingston, Ontario, Canada

Fowler Kennedy Sports Medicine Clinic

London, Ontario, Canada

Outcomes

Primary Outcomes

Pain (measured using a Visual Analog Scale)

The VAS is one of the most frequently used pain rating scales in clinical practice and research. The VAS is a validated unidimensional scale that is easy to use, requires no verbal or reading skills, and is sufficiently versatile to be employed in a variety of settings. The VAS will be administered during routine follow up visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.

Time frame: 12 months

Secondary Outcomes

Function (measured using the Hip Outcome Score)

The HOS is a self-administered hip score that was designed to capture hip function and outcomes following surgical therapies such as arthroscopy. The HOS has been shown to have the greatest clinimetric evidence for use in patients with FAI or labral tears.

Time frame: 12 months

Health-related quality of life (measured using the Short-Form 12)

The SF-12 may be self or interview-administered and will help document general health status as well as the burden of illness that FAI presents.

Time frame: 12 months

Function and lifestyle (measured using the International Hip Outcome Tool)

The iHOT-12 is a shorter version of the iHOT-33 designed to be easier to complete in routine clinical practice to measure both health-related quality of life and changes after treatment in young, active patients with hip disorders. This questionnaire has been shown to be valid, reliable, and responsive to change.

Time frame: 12 months

Health utility (measured using the Euro-Quol 5 Dimensions)

The EQ-5D is a standardized instrument for use as a measure of health outcome. The EQ-5D comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The EQ-5D has been used in previous studies involving patients with hip pain and has been extensively validated. Our decision to the use EQ-5D was based upon our interest in collecting health utility data for a formal economic analysis.

Data from ClinicalTrials.gov

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