Clinical trial NCT01623843: Femoroacetabular Impingement RandomiSed Controlled Trial
Official title: Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST); Sub-study: Femoroacetabular Impingement RandomiSed Controlled Trial With an Embedded Prospective Cohort (FIRST-EPIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoroacetabular Impingement
Keywords: FAI
randomized
hip arthroscopy
lavage
osteochondroplasty
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: McMaster Surgical Associates
name: Canadian Orthopaedic Foundation
name: American Orthopaedic Society for Sports Medicine
First posted: 2012-06-20
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain (measured using a Visual Analog Scale)
timeFrame: 12 months
Secondary outcomes:
measure: Function (measured using the Hip Outcome Score)
timeFrame: 12 months
measure: Health-related quality of life (measured using the Short-Form 12)
timeFrame: 12 months
measure: Function and lifestyle (measured using the International Hip Outcome Tool)
timeFrame: 12 months
measure: Health utility (measured using the Euro-Quol 5 Dimensions)
timeFrame: 12 months
measure: Urinary function (measured using the Male/Female Lower Urinary Tract Symptoms questionnaires)
timeFrame: 12 months
measure: Sexual function (measured using the International Index of Erectile Dysfunction and the Female Sexual Function Index)
timeFrame: 12 months
measure: Complications / Adverse events
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: Fowler Kennedy Sports Medicine Clinic
state: Ontario
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Quebec City
country: Canada
facility: CHU de Québec, L'Hôtel-Dieu de Québec
state: Quebec
city: Odense
country: Denmark
facility: Odense University Hospital
city: Tampere
country: Finland
facility: Hatanpää Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: McMaster Univerity
name: Olufemi Ayeni, MD, MSc, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kay J, Simunovic N, Ayeni OR; FIRST Investigators; Bhandari M, Bedi A, Jarvinen T, Musahl V, Naudie D, Seppanen M, Slobogean G, Thabane L, Duong A, Skelly M, Shanmugaraj A, Crouch S, Sprague S, Heels-Ansdell D, Buckingham L, Ramsay T, Lee J, Kousa P, Carsen S, Choudur H, Sim Y, Johnston K, Wong I, Murphy R, Sparavalo S, Whelan D, Khan R, Wood GCA, Howells F, Grant H, Zomar B, Pollock M, Willits K, Firth A, Wanlin S, Remtulla A, Kaniki N, Belzile EL, Turmel S, Jorgensen U, Gam-Pedersen A, Sihvonen R, Raivio Sihvonen M, Toivonen Sihvonen P, Pirjetta Routapohja M. Effect of Osteochondroplasty on Time to Reoperation After Arthroscopic Management of Femoroacetabular Impingement: Analysis of a Randomized Controlled Trial. Orthop J Sports Med. 2022 Apr 5;10(4):23259671211041400. doi: 10.1177/23259671211041400. eCollection 2022 Apr.
citation: Femoroacetabular Impingement Randomized Controlled Trial (FIRST) Investigators; Ayeni OR, Karlsson J, Heels-Ansdell D, Thabane L, Musahl V, Simunovic N, Duong A, Bhandari M, Bedi A, Jarvinen T, Naudie D, Seppanen M, Slobogean G, Skelly M, Shanmugaraj A, Crouch S, Sprague S, Buckingham L, Ramsay T, Lee J, Kousa P, Carsen S, Choudur H, Sim Y, Johnston K, Sprague S, Wong I, Murphy R, Sparavalo S, Whelan D, Khan R, Wood GCA, Howells F, Grant H, Naudie D, Zomar B, Pollock M, Willits K, Firth A, Wanlin S, Remtulla A, Kaniki N, Belzile EL, Turmel S, Jorgensen U, Gam-Pedersen A, Hatanpaa T, Sihvonen R, Raivio M, Toivonen P, Routapohja MP. Osteochondroplasty and Labral Repair for the Treatment of Young Adults With Femoroacetabular Impingement: A Randomized Controlled Trial. Am J Sports Med. 2021 Jan;49(1):25-34. doi: 10.1177/0363546520952804. Epub 2020 Sep 24.
citation: Simunovic N, Heels-Ansdell D, Thabane L, Ayeni OR; FIRST Investigators. Femoroacetabular Impingement Randomised controlled Trial (FIRST) - a multi-centre randomized controlled trial comparing arthroscopic lavage and arthroscopic osteochondroplasty on patient important outcomes and quality of life in the treatment of young adult (18-50 years) femoroacetabular impingement: a statistical analysis plan. Trials. 2018 Oct 29;19(1):588. doi: 10.1186/s13063-018-2965-0.
citation: FIRST Investigators. A multi-centre randomized controlled trial comparing arthroscopic osteochondroplasty and lavage with arthroscopic lavage alone on patient important outcomes and quality of life in the treatment of young adult (18-50) femoroacetabular impingement. BMC Musculoskelet Disord. 2015 Mar 20;16:64. doi: 10.1186/s12891-015-0500-y.