ACL SNNAP Trial: ACL Surgery Necessity in Non Acute Patients
- Conditions
- Anterior Cruciate Ligament Injury
- Interventions
- Procedure: Surgical Management (Reconstruction)Other: Non-Surgical Management (Rehabilitation)
- Registration Number
- NCT02980367
- Lead Sponsor
- University of Oxford
- Brief Summary
The primary objective of this study is to determine in patients with non-acute Anterior Cruciate Ligament Deficiency (ACLD) whether a strategy of non-surgical management \[Rehabilitation\] (with option for later ACL reconstruction, only if required) is more clinically effective and cost effective than a strategy of surgical management \[Reconstruction\].
- Detailed Description
The ACL SNNAP study is a pragmatic multi-centre randomised controlled trial with two-arm parallel groups and 1:1 allocation ratio to compare non-surgical management (Rehabilitation) and surgical management (Reconstruction) options for patients with a symptomatic non-acute ACL deficient knee.
The objective is to determine, in patients with non-acute Anterior Cruciate Ligament Deficiency (ACLD), whether non-surgical treatment (with the option for later ACL reconstruction if required) is more effective than surgical ACL reconstruction (as measured by the Knee Injury and Osteoarthritis Outcome Score \[KOOS4\] at 18 months from randomisation).
Target sample size is 320 patients recruited from approx. 30 NHS orthopaedic units.
An internal pilot will be conducted with clear progression criteria regarding recruitment.
Both interventions are routine NHS treatments. Intervention content is based on a minimal set of pre-established criteria in order to ensure the integrity of the comparison while allowing for varying in practice in delivering the interventions between both surgeons and physiotherapists. This largely pragmatic approach will allow clinical management to reflect current practice and resource use within the NHS thus aiding generalisation.
Other than the allocated intervention, both groups will be followed-up in the same way to exclude bias. Follow up for study purposes will be by patient self-reported questionnaire completed using an electronic data capture collection system (a postal option will also be available). The questionnaire will include the outcomes indicated in section 4 and will be completed by participants at baseline, 6, 12 and 18 months. Non-response will be minimised through use of multiple reminders such as web based, phone and text.
Neither participants nor health care practitioners (surgeons and physiotherapists) can be blinded to receipt of the intervention.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Symptomatic ACL deficiency of the native ligament1 (instability-episodes of frank giving way or feeling unstable) with ACL deficiency (either partial or complete tear) confirmed using clinical assessment and MRI scan.
- Acute phase of primary ACL injury i.e. not recovered from any acute symptoms relating to their initial ACL injury.
- Previous knee surgery (other than diagnostic arthroscopy or partial meniscectomy) to index knee concomitant severe injury to contra-lateral knee.
- Meniscal pathology with characteristics that indicate immediate surgery i.e. locked knee, large bucket handle or complex cartilage tear producing mechanical symptoms.
- Knee joint status of grade 3 or 4 on the Kellgren and Lawrence scale,
- Grade 3 MCL/LCL injury, associated PCL/PLC injury
- Inflammatory arthropathy.
- Pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACL Reconstruction Group Surgical Management (Reconstruction) Surgical Management - Anterior Cruciate Ligament (ACL) reconstruction surgery ACL Rehabilitation Group Non-Surgical Management (Rehabilitation) Non-surgical management \[Rehabilitation\] with option for later Anterior Cruciate Ligament (ACL) reconstruction, only if required.
- Primary Outcome Measures
Name Time Method Knee Injury and Osteoarthritis Outcome Score (KOOS4) 18 months post randomisation The score is derived from 4 of 5 subscales; pain, symptoms, difficulty in sports and recreational activities, knee related quality of life.
- Secondary Outcome Measures
Name Time Method Modified Tegner scale At baseline and at 6, 12 and 18 months post randomisation Activity level will be assessed using the Modified Tegner scale, graded from 1 (low activity levels) to 10 (professional level).
Resource-usage data 18 months post randomisation Detailed resource use data on initial treatments received (surgical reconstruction or rehabilitation) and on subsequent healthcare contacts including re-operations (surgery arm), subsequent surgical reconstructions (rehabilitation arm), surgery-related complications, further rehabilitation, and primary care and other secondary care contacts out to 18 months post-randomisation. In addition, data will be collected on ability to work (e.g. sickness absences/return to work number of days off work and subjective working ability).
Anterior Cruciate Ligament Quality of Life score (ACL-QOL) At baseline and at 6, 12 and 18 months post randomisation Expectations of return to activity and confidence in relation to the knee.
Intervention related complications At 6, 12 and 18 months post randomisation Any complications associated with undergoing ACL deficiency treatment will be recorded. This includes; for surgery group; re-admission, delayed hospital discharge, infection, unexpected poor range of movement (stiffness), excess bleeding, continued swelling, episodes of giving way, continued feeling of instability. For non-surgical group; continued swelling, episodes of giving way.
EuroQol EQ-5D-5L At baseline and at 6, 12 and 18 months post randomisation Generic quality of life (self-reported outcome measure covering 5 health domains and used to facilitate the calculation of Quality Adjusted Life Years in health economic evaluations).
Knee Injury and Osteoarthritis Outcome Score (KOOS) At baseline and at 6, 12 and 18 months post randomisation All 5 subscales of the KOOS will be included (the fifth scale being activities of daily living).
Anterior Cruciate Ligament Quality of Life Score (ACL-QOL)Patient satisfaction At baseline and at 6, 12 and 18 months post randomisation Simple Likert scale
Trial Locations
- Locations (30)
Betsi Cadwaladr University Health Board
🇬🇧Wrexham, United Kingdom
Basildon and Thurrock University Hospitals NHS Foundation Trust
🇬🇧Basildon, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
🇬🇧Cheltenham, United Kingdom
Countess of Chester Hospital NHS Foundation Trust
🇬🇧Chester, United Kingdom
North Bristol NHS Trust
🇬🇧Bristol, United Kingdom
Frimley Health NHS Foundation Trust
🇬🇧Slough, United Kingdom
Royal Surrey County Hospitals NHS Foundation Trust
🇬🇧Guildford, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
🇬🇧Hull, United Kingdom
University Hospitals of Leicester
🇬🇧Leicester, United Kingdom
Kings College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
University College London Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Manchester University NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
Portsmouth Hospitals NHS Trust
🇬🇧Portsmouth, United Kingdom
Royal Berkshire NHS Foundation Trust
🇬🇧Reading, United Kingdom
Salisbury NHS Foundation Trust
🇬🇧Salisbury, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
Stockport NHS Foundation Trust
🇬🇧Stockport, United Kingdom
Abertawe Bro Morannwg University Health Board
🇬🇧Swansea, United Kingdom
Sherwood Forest Hospitals NHS Foundation Trust
🇬🇧Sutton In Ashfield, United Kingdom
Taunton and Somerset NHS Foundation Trust
🇬🇧Taunton, United Kingdom
Great Western Hospitals NHS Foundation Trust
🇬🇧Swindon, United Kingdom
The Mid Yorkshire Hospitals NHS Trust
🇬🇧Wakefield, United Kingdom
Warrington and Halton Hospitals NHS Foundation Trust
🇬🇧Warrington, United Kingdom
Wrightington, Wigan and Leigh NHS Foundation Trust
🇬🇧Wigan, United Kingdom
Yeovil District Hospital NHS Foundation Trust
🇬🇧Yeovil, United Kingdom
North West Anglia NHS Foundation Trust
🇬🇧Peterborough, United Kingdom
Royal Cornwall Hospitals NHS Trust
🇬🇧Truro, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
🇬🇧Coventry, United Kingdom