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. 2018 Oct 29;19(1):588.
doi: 10.1186/s13063-018-2965-0.

Femoroacetabular Impingement Randomised controlled Trial (FIRST) - a multi-centre randomized controlled trial comparing arthroscopic lavage and arthroscopic osteochondroplasty on patient important outcomes and quality of life in the treatment of young adult (18-50 years) femoroacetabular impingement: a statistical analysis plan

Nicole Simunovic  1 , D Heels-Ansdell  2 , L Thabane  2   3 , O R Ayeni  4 ; FIRST Investigators
Collaborators, Affiliations

Femoroacetabular Impingement Randomised controlled Trial (FIRST) - a multi-centre randomized controlled trial comparing arthroscopic lavage and arthroscopic osteochondroplasty on patient important outcomes and quality of life in the treatment of young adult (18-50 years) femoroacetabular impingement: a statistical analysis plan

Nicole Simunovic et al. Trials. .

Abstract

Background: The research objectives of the Femoroacetabular Impingement Randomised controlled Trial (FIRST) are to assess whether surgical correction of the hip impingement morphology (arthroscopic osteochondroplasty) with or without labral repair, in adults aged 18-50 years diagnosed with non-arthritic femoroacetabular impingement (FAI), provides decreased pain and improved health-related quality of life at 12 months compared to arthroscopic lavage of the hip joint. This article describes the statistical analysis plan for the FIRST trial.

Methods/design: FIRST is an ongoing multi-centre, blinded randomised controlled trial of 220 patients who have been diagnosed with FAI and are optimized for surgical intervention. This article describes the overall analysis principles, including how participants will be included in each analysis, the presentation of the results, adjustments for covariates, the primary and secondary outcomes and their respective analyses. In addition, we will present the planned sensitivity and subgroup analyses.

Discussion: Our rationale for FIRST is based upon (1) an epidemic of FAI surgery with resultant increased healthcare costs over that last decade, (2) worldwide disparity in perceptions about its utility, and (3) consensus that definitive evidence for or against surgical approaches is lacking.

Trial registration: ClinicalTrials.gov, NCT01623843 . Registered on 20 June 2012.

Keywords: Femoroacetabular impingement; Lavage; Osteochondroplasty; Randomised controlled trial; Statistical analysis plan.

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Conflict of interest statement

Ethics approval and consent to participate

Ethics approval, including consent form approval, was granted at the Methods Centre at McMaster University (Hamilton Integrated Research Ethics Board #12–396) and at each participating site (as per their local ethics board).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Femoroacetabular Impingement Randomised controlled Trial (FIRST) process overview. MRI, magnetic resonance imaging; MRA, magnetic resonance angiography; FAI, femoroacetabular impingement; VAS, visual analogue scale; HOS, Hip Outcome Score; iHOT, International Hip Outcome Tool; SF-12 Short Form-12; EQ-5D, EuroQol-5 Dimensions
Fig. 2
Fig. 2
Subgroup analyses of the primary end point, according to treatment group
See this image and copyright information in PMC

References

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