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Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST)

Primary Purpose

Femoroacetabular Impingement

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Arthroscopic Lavage
Arthroscopic Osteochondroplasty
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoroacetabular Impingement focused on measuring FAI, randomized, hip arthroscopy, lavage, osteochondroplasty

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dalhousie University
  • McMaster University
  • Kingston General Hospital
  • Fowler Kennedy Sports Medicine Clinic
  • London Health Sciences
  • St. Michael's Hospital
  • CHU de Québec, L'Hôtel-Dieu de Québec
  • Odense University Hospital
  • Hatanpää Hospital
  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arthroscopic Lavage

Arthroscopic Osteochondroplasty

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Urinary function (measured using the Male/Female Lower Urinary Tract Symptoms questionnaires)
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)
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
Includes additional surgery, infection, reduced range of motion, and other adverse events

Full Information

First Posted
June 17, 2012
Last Updated
August 20, 2020
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), McMaster Surgical Associates, Canadian Orthopaedic Foundation, American Orthopaedic Society for Sports Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01623843
Brief Title
Femoroacetabular Impingement RandomiSed Controlled Trial
Acronym
FIRST
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), McMaster Surgical Associates, Canadian Orthopaedic Foundation, American Orthopaedic Society for Sports Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement
Keywords
FAI, randomized, hip arthroscopy, lavage, osteochondroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopic Lavage
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arthroscopic Osteochondroplasty
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Lavage
Intervention Description
Lavage: inflammation debris caused from continual friction in the hip is washed out.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Osteochondroplasty
Intervention Description
Osteochondroplasty: reshaping the hip ball and socket ("osteoplasty" or "rim trimming").
Primary Outcome Measure Information:
Title
Pain (measured using a Visual Analog Scale)
Description
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 Outcome Measure Information:
Title
Function (measured using the Hip Outcome Score)
Description
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
Title
Health-related quality of life (measured using the Short-Form 12)
Description
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
Title
Function and lifestyle (measured using the International Hip Outcome Tool)
Description
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
Title
Health utility (measured using the Euro-Quol 5 Dimensions)
Description
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.
Time Frame
12 months
Title
Urinary function (measured using the Male/Female Lower Urinary Tract Symptoms questionnaires)
Description
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.
Time Frame
12 months
Title
Sexual function (measured using the International Index of Erectile Dysfunction and the Female Sexual Function Index)
Description
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.
Time Frame
12 months
Title
Complications / Adverse events
Description
Includes additional surgery, infection, reduced range of motion, and other adverse events
Time Frame
12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olufemi Ayeni, MD, MSc, FRCSC
Organizational Affiliation
McMaster Univerity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Fowler Kennedy Sports Medicine Clinic
City
London
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences
City
London
State/Province
Ontario
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
CHU de Québec, L'Hôtel-Dieu de Québec
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
Hatanpää Hospital
City
Tampere
ZIP/Postal Code
33900
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20540
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
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Femoroacetabular Impingement RandomiSed Controlled Trial

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