FIRST: Femoroacetabular Impingement RandomiSed Controlled Trial

Sponsor

McMaster University (Other)

Overall Status

Completed

CT.gov ID

NCT01623843

Collaborator

Canadian Institutes of Health Research (CIHR) (Other), McMaster Surgical Associates (Other), Canadian Orthopaedic Foundation (Other), American Orthopaedic Society for Sports Medicine (Other)

220

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Femoroacetabular Impingement	Procedure: Arthroscopic Lavage Procedure: Arthroscopic Osteochondroplasty	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST); Sub-study: Femoroacetabular Impingement RandomiSed Controlled Trial With an Embedded Prospective Cohort (FIRST-EPIC)

Actual Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arthroscopic Lavage Participants have three hip portals (antero-lateral, mid anterior, distal antero-lateral) with limited capsulotomy allowing for a complete assessment of the central and peripheral compartments. The participant has a diagnostic arthroscopy and lavage of the hip joint with three litres of normal saline. No osteochondroplasty or rim resection is completed in this group. No instruments are used to treat minor cartilage or labral damage. The labrum should only be repaired if mechanically unstable once probed with visible displacement or chondrolabral separation. The labrum will be refixated only if the above criteria for labral instability is met.	Procedure: Arthroscopic Lavage Lavage: inflammation debris caused from continual friction in the hip is washed out.
Experimental: Arthroscopic Osteochondroplasty After establishing standard portals, an inter-portal capsulotomy will be completed to allow for complete evaluation of the central compartment of the hip. Significant and obvious labral tears and cartilage damage will be addressed. The labrum will be repaired if mechanically unstable once probed with visible displacement or chondrolabral separation. The acetabular rim will be evaluated and any evident Pincer lesion will be resected using an arthroscopic burr under fluoroscopic guidance. Following this resection, the labrum will be refixated only if the criteria for labral instability is met. Following this, a limited capsulotomy will be completed along the head-neck junction of the femoral neck to allow for visualization and treatment of the impingement lesion in the peripheral compartment. For the FIRST-EPIC sub-study, participants will receive the osteochondroplasty intervention as per standard of care.	Procedure: Arthroscopic Osteochondroplasty Osteochondroplasty: reshaping the hip ball and socket ("osteoplasty" or "rim trimming").

Arm

Intervention/Treatment

Active Comparator: Arthroscopic Lavage

Participants have three hip portals (antero-lateral, mid anterior, distal antero-lateral) with limited capsulotomy allowing for a complete assessment of the central and peripheral compartments. The participant has a diagnostic arthroscopy and lavage of the hip joint with three litres of normal saline. No osteochondroplasty or rim resection is completed in this group. No instruments are used to treat minor cartilage or labral damage. The labrum should only be repaired if mechanically unstable once probed with visible displacement or chondrolabral separation. The labrum will be refixated only if the above criteria for labral instability is met.

Procedure: Arthroscopic Lavage

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

Experimental: Arthroscopic Osteochondroplasty

After establishing standard portals, an inter-portal capsulotomy will be completed to allow for complete evaluation of the central compartment of the hip. Significant and obvious labral tears and cartilage damage will be addressed. The labrum will be repaired if mechanically unstable once probed with visible displacement or chondrolabral separation. The acetabular rim will be evaluated and any evident Pincer lesion will be resected using an arthroscopic burr under fluoroscopic guidance. Following this resection, the labrum will be refixated only if the criteria for labral instability is met. Following this, a limited capsulotomy will be completed along the head-neck junction of the femoral neck to allow for visualization and treatment of the impingement lesion in the peripheral compartment. For the FIRST-EPIC sub-study, participants will receive the osteochondroplasty intervention as per standard of care.

Procedure: Arthroscopic Osteochondroplasty

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

Outcome Measures

Primary Outcome Measures

Pain (measured using a Visual Analog Scale) [12 months]
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.

Secondary Outcome Measures

Function (measured using the Hip Outcome Score) [12 months]
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.
Health-related quality of life (measured using the Short-Form 12) [12 months]
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.
Function and lifestyle (measured using the International Hip Outcome Tool) [12 months]
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.
Health utility (measured using the Euro-Quol 5 Dimensions) [12 months]
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.
Urinary function (measured using the Male/Female Lower Urinary Tract Symptoms questionnaires) [12 months]
The two validated questionnaires selected that pertain to male and female urinary symptoms are gender specific variations of the International Consultation on Continence Questionnaire (ICIQ). The ICIQ-MLUTS (male) and ICIQ-FLUTS (female). These are validated patient-completed questionnaires, which evaluate male and female lower urinary tract symptoms (LUTS), as well as quality of life. Both questionnaires have demonstrated validity, reliability and responsiveness internally and externally.
Sexual function (measured using the International Index of Erectile Dysfunction and the Female Sexual Function Index) [12 months]
The FSFI is a brief psychometrically sound and reliable tool that assesses female sexual function, and has proven ability to discriminate between clinical and nonclinical populations.The FSFI is also designed to measure the impact on quality of life. The IIEF is a brief self-administered questionnaire assessing sexual experience within the previous 4 weeks, consisting of 15 questions designed to address 5 relevant aspects of male sexual function, specifically erectile function, sexual desire, orgasmic function, intercourse satisfaction and overall satisfaction. This instrument is psychometrically sound with high sensitivity and specificity, which has been validated for administration in research and clinical settings, and across cultures with linguistically validated versions.
Complications / Adverse events [12 and 24 months]
Includes additional surgery, infection, reduced range of motion, and other adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult men or women ages 18 to 50 years
Hip pain for greater than 6 months with no relief from non-operative means (physiotherapy, non-steroidal anti-inflammatory medication, rest)
Documentation of failed physiotherapy, including core conditioning of the hip, back, and abdomen
CAM or Mixed Type FAI as diagnosed on x-rays and magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA)
Temporary relief from an intra-articular hip injection
Informed consent from participant
Ability to speak, understand and read in the language of the clinical site

Exclusion Criteria:

Previous inclusion in a study involving FAI
Evidence of hip dysplasia (centre edge angle less than 20)
Presence of advanced hip osteoarthritis (Tonnis Grade 2 or 3)
Presence of other hip syndromes (concurrent non-FAI related pathology)
Previous trauma to the affected hip
Previous surgery on the affected hip or contralateral hip
Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda, circumferential labral ossification)
Immunosuppressive medication use
Chronic pain syndromes
Significant medical co-morbidities (requiring daily assistance for ADLs)
History of paediatric hip disease (Legg-Calve-Perthes; slipped capital femoral epiphysis)
Ongoing litigation or compensation claims secondary to hip problems
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dalhousie University	Halifax	Nova Scotia	Canada
2	McMaster University	Hamilton	Ontario	Canada	L8N 3Z5
3	Kingston General Hospital	Kingston	Ontario	Canada
4	Fowler Kennedy Sports Medicine Clinic	London	Ontario	Canada
5	London Health Sciences	London	Ontario	Canada
6	St. Michael's Hospital	Toronto	Ontario	Canada
7	CHU de Québec, L'Hôtel-Dieu de Québec	Quebec City	Quebec	Canada
8	Odense University Hospital	Odense		Denmark
9	Hatanpää Hospital	Tampere		Finland	33900
10	Turku University Hospital	Turku		Finland	20540