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01.12.2015 | Study protocol | Ausgabe 1/2015 Open Access

BMC Musculoskeletal Disorders 1/2015

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

Zeitschrift:
BMC Musculoskeletal Disorders > Ausgabe 1/2015
Autor:
FIRST Investigators
Wichtige Hinweise

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

OA, MB, AB, TJ, VM, DN, MS, GS, DW, and LT made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data. OA, NS, MS, SS, and MB have been involved in drafting the manuscript or revising it critically for important intellectual content. All authors read and approved the final manuscript.
Writing Committee: Olufemi Ayeni, Nicole Simunovic, Matti Seppänen, Daniel Whelan, Sheila Sprague, Mohit Bhandari.
Steering Committee: Olufemi Ayeni (Chair), Mohit Bhandari (Co-Chair), Asheesh Bedi, Teppo Järvinen, Volker Musahl, Douglas Naudie, Matti Seppänen, Gerard Slobogean, Lehana Thabane.
Methods Centre(McMaster University): Olufemi Ayeni (Principal Investigator); Sheila Sprague (Research Program Manager); Nicole Simunovic (Research Coordination); Diane Heels-Ansdell, (Statistical Analysis); Lisa Buckingham (Data Management).
Central Adjudication Committee: Dale Williams, Rajiv Gandhi, Matti Seppänen.
Data Safety Monitoring Board: Tim Ramsay (Chair), John Lee, Petteri Kousa.

Abstract

Background

Several cross-sectional studies have estimated that the prevalence of femoroacetabular impingement (FAI) ranges from 14-17% among asymptomatic young adults to almost 95% among competitive athletes. With FAI, there is abnormal contact between the proximal femur and the acetabulum, resulting in abnormal mechanics with terminal motion such as hip flexion and rotation. This condition results from bony anomalies of the acetabular rim (Pincer) and or femoral head/neck junction (CAM) and typically causes hip pain and decreased hip function. The development of hip pain potentially serves as an indicator for early cartilage and labral damage that may result in hip osteoarthritis. Although surgical correction of the misshaped bony anatomy and associated intra-articular soft tissue damage of the hip is thought to improve hip pain and alter the natural history of degenerative disease, the supportive evidence is based upon low quality observational studies. The Femoroacetabular Impingement RandomiSed controlled Trial (FIRST) compares outcomes following surgical correction of the impingement morphology (arthroscopic osteochondroplasty) with/without labral repair versus arthroscopic lavage of the hip joint in adults aged 18 to 50 diagnosed with FAI.

Methods and design

FIRST is a multi-centre, randomized controlled trial with a sample size of 220 patients. Exclusion criteria include the presence of hip syndromes, previous surgery or trauma to the affected hip, and significant medical comorbidities. The primary outcome is pain and the secondary outcomes include patient function, quality of life, complications, and cost-effectiveness – all within one year of follow-up. Patients are stratified based on centre and impingement sub-type. Patients, outcome assessors, data analysts, and the Steering Committee are blinded to surgical allocation. Using an intention-to-treat approach, outcome analyses will be performed using an analysis of covariance and descriptive statistics.

Discussion

Symptomatic FAI is associated with chronic hip pain, functional limitations, and secondary osteoarthritis. Therefore, optimizing treatment has the potential to improve the lives millions of young, active persons who are diagnosed with this condition. Few orthopaedic surgical trials have similar potential to shift the paradigm of care dramatically towards (or away) from surgical bony and soft tissue interventions.

Trial registration

The FIRST trial is registered with clinicaltrials.gov (NCT01623843).
Literatur
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