Abstract
BACKGROUND: Rupture of the anterior cruciate ligament (ACL) is a common injury, primarily affecting young, active individuals. Despite surgical intervention being the more common treatment for patients suffering ACL ruptures, current management is based on limited and generally low-quality evidence. We describe a statistical analysis plan (SAP) for the ACL SNNAP randomised controlled trial, which aims to investigate the necessity of surgical management in patients with ACL injuries.
METHODS/DESIGN: ACL SNNAP is a pragmatic, multi-centre, superiority, parallel-group randomised controlled trial in participants with a symptomatic non-acute ACL deficient knee. Participants are allocated in a 1:1 ratio to either non-surgical management (rehabilitation) or surgical management (reconstruction) with the aim of assessing the efficacy and cost-effectiveness. The primary outcome of the study is the Knee Injury and Osteoarthritis Outcome Score (KOOS4) at 18 months post-randomisation. The KOOS4 score at 18 months will be evaluated using a linear regression model adjusting for recruitment centre and baseline KOOS4 scores, allowing for intra-centre correlation. A secondary analysis of the primary outcome will be carried out using an area under the curve (AUC) approach using treatment estimates obtained from a mixed model using baseline, 6 months, 12 months, and 18 months post-randomisation outcome data. Secondary outcomes will be measured at 18 months and will include return to activity/level of sport participation, intervention-related complications, the EQ-5D-5L questionnaire, all 5 individual subscales of the KOOS questionnaire, the ACL-QOL score, expectations of return to activity and cost-effectiveness of the interventions. Missing primary outcome data will be investigated through a sensitivity analysis. Full details of the planned methods for the statistical analysis of clinical outcomes are presented in this paper. The study protocol for the ACL SNNAP trial has been published previously.
DISCUSSION: The methods of analysis for the ACL SNNAP trial have been described here to minimise the risk of data-driven results and reporting bias. Any deviations from the analysis methods described in this paper will be described in full and justified in the publications of the trial results.
TRIAL REGISTRATION: ISRCTN ISRCTN10110685 . Registered on 16 November 2016.
| Original language | English |
|---|---|
| Article number | 389 |
| Number of pages | 9 |
| Journal | Trials |
| Volume | 23 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 12 May 2022 |
Bibliographical note
Funding Information:This trial is supported by the NIHR Biomedical Research Unit at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, the NIHR Clinical Research Network and the Oxford Clinical Trials Research Unit. The data collection platform was supplied by Fre3dom Ltd. The trial is run by the RCS Surgical Interventions Trials Unit, Oxford. Trial Steering Committee: Marion Campbell (Chair, independent member), David Beard (chief investigator, non-independent member), Stephen McDonald (independent member), Thomas Pinkney (independent member), Hilary Johnson (independent member), Mark Williams (independent member), Jonathan Cook (non-independent member) and Tessa Howell (independent member, patient representative). Independent Data Monitoring Committee: Richard Emsley (Chair, independent member), George Peat (independent member) and Martyn Snow (independent member). ACL SNNAP Co-applicant Study Group: Karen Barker, Andrew Carr, Jonathan Cook, Loretta Davies, Fares Haddad, William Jackson, Sallie Lamb, Jose Leal, Paul Monk, Sean O’Leary, Andrew Price and Chris Wilson.
Funding Information:
This study/project is funded by the National Institute for Health Research (NIHR) under the Health Technology Assessment (HTA) programme (Ref 14/140/63). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no involvement in the design or conduct of the trial.
Funding Information:
This trial is supported by the NIHR Biomedical Research Unit at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, the NIHR Clinical Research Network and the Oxford Clinical Trials Research Unit. The data collection platform was supplied by Fre3dom Ltd.
Publisher Copyright:
© 2022, The Author(s).
Keywords
- Anterior Cruciate Ligament/surgery
- Anterior Cruciate Ligament Injuries/diagnosis
- Anterior Cruciate Ligament Reconstruction/adverse effects
- Humans
- Knee Injuries/diagnosis
- Quality of Life
- Treatment Outcome