The authors declare that they have no competing interests.
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.
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.
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.
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.
The FIRST trial is registered with clinicaltrials.gov (NCT01623843).
Kapron AL, Anderson AE, Aoki SK, Phillips LG, Petron DJ, Toth R, et al. Radiographic prevalence of femoroacetabular impingement in collegiate football players: AAOS Exhibit Selection. J Bone Joint Surg Am. 2011;93:e111(1–10). CrossRef
Beck M, Kalhor M, Leunig M, Ganz R. Hip morphology influences the pattern of damage to the acetabular cartilage: femoroacetabular impingement as a cause of early osteoarthritis of the hip. J Bone Joint Surg (Br). 2005;87:1012–8. CrossRef
Ganz R, Parvizi J, Beck M, Leunig M, Nötzli H, Siebenrock KA. Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res. 2003;417:112–20. PubMed
Colvin AC, Harrast J, Harner C. Trends in hip arthroscopy. J Bone Joint Surg Am. 2012;94:e23. PubMed
Millennium Research Group. An evolution in keyhole surgery: arthroscopy goes for the hip. IQ Industry Insight. 2009, 1–3. Ref Type: Pamphlet.
Kolata G. Hip procedure grows popular despite doubt. The New York Times. 15 Nov 2011. [ http://www.nytimes.com/2011/11/16/health/hip-impingement-grows-popular-but-remains-unproven.html?_r=0].
Schenker ML, Martin R, Weiland DE, Philippon MJ. Current trends in hip arthroscopy: a review of injury diagnosis, techniques and outcome scoring. Curr Opin Orthop. 2005;16:89–94. CrossRef
EuroQol Group. The EQ-5D. [ http://www.euroqol.org/home.html].
Tonnis D, Heinecke A. Current concepts review-Acetabular and femoral anteversion: relationship with osteoarthritis of the hip. J Bone Joint Surg Am. 1999;81:1747–70. PubMed
Haynes S. Guyatt and Tugwell: Clinical Epidemiology: How to do Clinical Practice Research. New York: Lipincott Williams and Wilkins; 2006.
Throborg K, Roos EM, Bartels EM, Petersen J, Hölmich P. Validity, reliability and responsiveness of patient-reported outcome questionnaires when assessing hip and groin disability: a systematic review. Br J Sports Med. 2010;44:1186–96. CrossRef
Mohtadi NGH, Griffin DR, Pedersen ME, Chan D, Safran MR, Parsons N, et al. The development and validation of a self-administered quality-of-life outcome measure for young, active patients with symptomatic hip disease: the International Hip Outcome Tool (iHOT-33). Arthroscopy. 2012;28:595–610. CrossRefPubMed
Byrd JW. Complications associated with hip arthroscopy. In: Operative Arthroscopy. New York: Thieme; 1998. p. 171–6.
Papvasiliou AV, Bardakos NV. Complications of arthroscopic surgery of the hip. Bone Joint Res. 2012;1:131–7. CrossRef
Sarramon JP, Malavaud B, Braud F, Bertrand N, Vaessen C, Rischmann P. Evaluation of male sexual function after deep dorsal vein arterialization of the penis. J Urology. 2001;166:576–80. CrossRef
Malviya A, Stafford GH, Villar RN. Impact of arthroscopy of the hip for femoroacetabular impingement on quality of life at a mean follow-up of 3.2 years. J Bone Joint Surg (Br). 2012;94:466–70. CrossRef
Nötzli HP, Wyss TF, Stoecklin CH, Schmid MR, Treiber K, Hodler J. The contour of the femoral head-neck junction as a predictor for the risk of anterior impingement. J Bone Joint Surg (Br). 2002;84:556–60. CrossRef
Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003;41:582–92. PubMed
Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. New Jersey: Lawrence Erlbaum Associates; 1988.
Little RJA, Rubin DB. Statistical Analysis with Missing Data. New York: John Wiley & Sons; 1987.
- 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
- BioMed Central
Neu im Fachgebiet Orthopädie und Unfallchirurgie
Mail Icon II