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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Nicole Simunovic, D. Heels-Ansdell, L. Thabane, O. R. Ayeni, on behalf of the FIRST Investigators

Published in: Trials | Issue 1/2018

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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.
Literature
1.
FIRST Investigators. 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. BMC Musculoskelet Disord. 2015;16:64.CrossRef
2.
Jensen MP, Karoly P. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27:117–26.CrossRef
3.
Collins S, Moore A, McQuay H. The visual analog pain intensity scale: what is moderate pain in millimeters? Pain. 1997;72:95–7.CrossRef
4.
Ho K, Spence J, Murphy M. Review of pain measurement tools. Ann Emerg Med. 1996;27:427–31.CrossRef
5.
Schenker ML, Martin R, Weiland DE, Philippon MJ. Current trends in hip arthroscopy: a review of injury diagnosis, techniques and outcome scoring. Curr Opin Orthopeadics. 2005;16:89–94.CrossRef
6.
Thorborg 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
7.
Mohtadi NGH, Griffin DR, Pedersen ME, Chan D, Safran MR, Parsons N, Sekiya JK, Kelly BT, Werle JR, Leunig M, JC MC, Martin HD, Byrd T, Philippon MJ, Martin RL, Guanche CA, Clohisy JC, Sampson TG, Kocher MS, Larson CM, for the Multicenter Arthroscopy of the Hip Outcomes Research Network (MAHORN). 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.CrossRef
8.
Ware J Jr, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–33.CrossRef
9.
Griffin DR, Parsons N, Mohtadi NGH, Safran MR, on behalf of the Multicenter Arthroscopy of the Hip Outcomes Research Network (MAHORN). A short version of the International Hip Outcome Tool (iHOT-12) for use in routine clinical practice. Arthroscopy. 2012;28:611–8.CrossRef
10.
11.
Bosch JL, Hunink MG. Comparison of the Health Utilities Index Mark 3 (HUI3) and the EuroQol EQ-5D in patients treated for intermittent claudication. Qual Life Res. 2000;9:591–601.CrossRef
12.
Hurst NP, Kind P, Ruta D, Hunter M, Stubbings A. Measuring health-related quality of life in rheumatoid arthritis: validity, responsiveness and reliability of EuroQol (EQ-5D). Br J Rheumatol. 1997;36:551–9.CrossRef
13.
Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Dore C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the content of statistical analysis plans in clinical trials. JAMA. 2017;318(23):2337–43.CrossRef
14.
Jarvinen TL, Sihvonen R, Bhandari M, Sprague S, Malmivaara A, Paavola M, Schunemann HJ, Guyatt GH. Blinded interpretation of study results can feasibly and effectively diminish interpretation bias. J Clin Epidemiol. 2014;67(7):769–72.CrossRef
15.
Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.CrossRef
16.
Zhang Y, Alyass A, Vanniyasingam T, Sadeghirad B, Florez ID, Pichika SC, Kennedy SA, Abdulkarimova U, Zhang Y, Iljon T, Morgano GP, Colunga Lozano LE, Aloweni FAB, Lopes LC, Yepes-Nunez JJ, Fei Y, Wang L, Kahale LA, Meyre D, Akl EA, Thabane L, Guyatt GH. A systematic survey of the methods literature on the reporting quality and optimal methods of handling participants with missing outcome data for continuous outcomes in randomized controlled trials. J Clin Epidemiol. 2017;88:67–80.CrossRef
17.
Chu R, Thabane L, Ma J, Holbrook A, Pullenayegum E, Devereaux PJ. Comparing methods to estimate treatment effects on a continuous outcome in multicentre randomized controlled trials: a simulation study. BMC Med Res Methodol. 2011;11:21.CrossRef
18.
Thabane L, Mbuagbaw L, Zhang S, Samaan Z, Marcucci M, Ye C, Thabane M, Giangregorio L, Dennis B, Kosa D, Borg Debono V, Dillenburg R, Fruci V, Bawor M, Lee J, Wells G, Goldsmith CH. A tutorial on sensitivity analyses in clinical trials: the what, why, when and how. BMC Med Res Methodol. 2013;13:92.CrossRef
19.
Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine – reporting of subgroup analyses in clinical trials. N Engl J Med. 2007;357:2189–94.CrossRef
20.
Agricola R, Heijboer MP, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Waarsing JH. Cam impingement causes osteoarthritis of the hip: a nationwide prospective cohort study (CHECK). Ann Rheum Dis. 2013;72(6):918–23.CrossRef
21.
Agricola R, Waarsing JH, Thomas GE, Carr AJ, Reijman M, Bierma-Zeinstra SM, Glyn-Jones S, Weinans H, Arden NK. Cam impingement: defining the presence of a cam deformity by the alpha angle: data from the CHECK cohort and Chingford cohort. Osteoarthr Cartil. 2014;22:218–25.CrossRef
22.
Agricola R, Waarsing JH, Arden NK, Carr AJ, Bierma-Zeinstra SM, Thomas GE, Weinans H, Glyn-Jones S. Cam impingement of the hip-a risk factor for hip osteoarthritis. Nat Rev Rheumatol. 2013;9:630–4.CrossRef
23.
Thomas DD, Bernhardson AS, Bernstein E, Dewing CB. Hip arthroscopy for femoroacetabular impingement in a military population. Am J Sports Med. 2017;45(14):3298–304.CrossRef
24.
Frank RM, Lee S, Bush-Joseph CA, Salata MJ, Mather RC 3rd, Nho SJ. Outcomes for hip arthroscopy according to sex and age: a comparative matched-group analysis. J Bone Joint Surg Am. 2016;98(10):797–804.CrossRef
25.
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.CrossRef
26.
Horner NS, Ekhtiari S, Simunovic N, Safran MR, Philippon MJ, Ayeni OR. Hip arthroscopy in patients age 40 or older: a systematic review. Arthroscopy. 2017;33(2):464–75.CrossRef
27.
Egerton T, Hinman RS, Takla A, Bennell KL, O'Donnell J. Intraoperative cartilage degeneration predicts outcome 12 months after hip arthroscopy. Clin Orthop Relat Res. 2013;471(2):593–9.CrossRef
28.
Ayeni OR, Adamich J, Farrokhyar F, Simunovic N, Crouch S, Philippon MJ, Bhandari M. Surgical management of labral tears during femoroacetabular impingement surgery: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2014;22(4):756–62.CrossRef
29.
Briel M, Lane M, Montori VM, Bassler D, Glasziou P, Malaga G, Akl EA, Ferreira-Gonzalez I, Alonso-Coello P, Urrutia G, Kunz R, Culebro CR, da Silva SA, Flynn DN, Elamin MB, Strahm B, Murad MH, Djulbegovic B, Adhikari NKJ, Mills EJ, Gwadry-Sridhar F, Kirpalani H, Soares HP, Elnour NOA, You JJ, Karanicolas PJ, Bucher HC, Lampropulos JF, Nordmann AJ, Burns KEA, Mulla SM, Raatz H, Sood A, Kaur J, Bankhead CR, Mullan RJ, Nerenberg KA, Vandvik PO, Coto-Yglesias F, Schunemann H, Tuche F, Chrispim PPM, Cook DJ, Lutz K, Ribic CM, Vale N, Erwin PJ, Perera R, Zhou Q, Heels-Ansdell D, Ramsay T, Walter SD, Guyatt GH. Stopping randomized clinical trials early for benefit: a protocol of the study of trial policy of interim truncation-2 (STOPIT-2). Trials. 2009;10:49.CrossRef
30.
Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, Lacchetti C, Leung TW, Darling E, Bryant DM, Bucher HC, Schunemann HJ, Meade MO, Cook DJ, Erwin PJ, Sood A, Sood R, Lo B, Thompson CA, Zhou Q, Mills E, Guyatt GH. Randomized trials stopped early for benefit: a systematic review. JAMA. 2005;294:2203–9.CrossRef
Metadata
Title
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
Authors
Nicole Simunovic
D. Heels-Ansdell
L. Thabane
O. R. Ayeni
on behalf of the FIRST Investigators
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2965-0

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