Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST)
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|ClinicalTrials.gov Identifier: NCT01623843|
Recruitment Status : Active, not recruiting
First Posted : June 20, 2012
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Femoroacetabular Impingement||Procedure: Arthroscopic Lavage Procedure: Arthroscopic Osteochondroplasty||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST); Sub-study: Femoroacetabular Impingement RandomiSed Controlled Trial With an Embedded Prospective Cohort (FIRST-EPIC)|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
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").
- Pain (measured using a Visual Analog Scale) [ Time Frame: 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.
- Function (measured using the Hip Outcome Score) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 12 and 24 months ]Includes additional surgery, infection, reduced range of motion, and other adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623843
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Kingston General Hospital|
|Kingston, Ontario, Canada|
|Fowler Kennedy Sports Medicine Clinic|
|London, Ontario, Canada|
|London Health Sciences|
|London, Ontario, Canada|
|St. Michael's Hospital|
|Toronto, Ontario, Canada|
|CHU de Québec, L'Hôtel-Dieu de Québec|
|Quebec City, Quebec, Canada|
|Odense University Hospital|
|Tampere, Finland, 33900|
|Turku University Hospital|
|Turku, Finland, 20540|
|Principal Investigator:||Olufemi Ayeni, MD, MSc, FRCSC||McMaster Univerity|