Femoroacetabular Impingement RandomiSed Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01623843
Study type	Interventional
Source	McMaster University
Contact
Status	Completed
Phase	N/A
Start date	September 2012
Completion date	March 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03669471` - Muscular and Functional Performance in FAIS Patients
Not yet recruiting	`NCT05031390` - the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study	N/A
Active, not recruiting	`NCT05025956` - Senolytic Agent Improve the Benefit of Platelet-Rich Plasma and Losartan	Phase 1/Phase 2
Withdrawn	`NCT02674113` - Regional Anesthesia in Hip Arthroscopy	N/A
Withdrawn	`NCT02260726` - Evaluation of Ultrasound for Detecting Hip Impingement	N/A
Recruiting	`NCT05391204` - Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls	N/A
Active, not recruiting	`NCT03891563` - Prospective Evaluation of Sport Activity and the Development of Femoroacetabular Impingement in the Adolescent Hip
Active, not recruiting	`NCT04069507` - Healthy Hip Study: Conservative Management for Pre-arthritic Hip Disorders
Terminated	`NCT03278353` - Fulfillment of Expectations for Patients With FAI Syndrome	N/A
Terminated	`NCT03995290` - 3D Modeling to Improve Hip Arthroscopy Outcomes
Completed	`NCT06082271` - Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy	N/A
Recruiting	`NCT01621360` - Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement	N/A
Completed	`NCT04980209` - The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping
Enrolling by invitation	`NCT04988659` - Analysis of Gene Expression in Femoroacetabular Impingement (FAI)
Active, not recruiting	`NCT03494660` - SCP Hip Outcomes Study
Active, not recruiting	`NCT04822571` - Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males	N/A
Withdrawn	`NCT02706756` - Conservative Intervention of Femoroacetabular Impingement Syndrome	N/A
Completed	`NCT01993615` - A Physical Therapy Program Versus Surgery for Femoroacetabular Impingement: Randomized Clinical Trial	N/A
Completed	`NCT02702661` - PRCT of FICB vs LAI for Hip Arthroscopy	N/A
Completed	`NCT01814124` - Conservative Management of Femoroacetabular Impingement	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Femoroacetabular Impingement RandomiSed Controlled Trial — FIRST

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms