ACL SNNAP Trial: ACL Surgery Necessity in Non Acute Patients
NCT ID: NCT02980367
Last Updated: 2021-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
320 participants
INTERVENTIONAL
2016-12-31
2022-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ACL Rehabilitation Group
Non-surgical management \[Rehabilitation\] with option for later Anterior Cruciate Ligament (ACL) reconstruction, only if required.
Non-Surgical Management (Rehabilitation)
Routine ACL rehabilitation protocols used at the participating site will be followed. As part of the site selection process, documentary evidence of the use of or willingness to adopt a rehabilitation protocol that reflects the guidelines of the mandatory aims/goals set for the study rehabilitation intervention will be required.
ACL Reconstruction Group
Surgical Management - Anterior Cruciate Ligament (ACL) reconstruction surgery
Surgical Management (Reconstruction)
All surgical reconstructions will be patella tendon or hamstrings tendon depending on the surgeon's preference. All other care will be routine, including immediate post-operative care.
Interventions
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Non-Surgical Management (Rehabilitation)
Routine ACL rehabilitation protocols used at the participating site will be followed. As part of the site selection process, documentary evidence of the use of or willingness to adopt a rehabilitation protocol that reflects the guidelines of the mandatory aims/goals set for the study rehabilitation intervention will be required.
Surgical Management (Reconstruction)
All surgical reconstructions will be patella tendon or hamstrings tendon depending on the surgeon's preference. All other care will be routine, including immediate post-operative care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
99 Years
ALL
No
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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David Beard, DPhil
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Betsi Cadwaladr University Health Board
Bangor, , United Kingdom
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, , United Kingdom
North Bristol NHS Trust
Bristol, , United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Cheltenham, , United Kingdom
Countess of Chester Hospital NHS Foundation Trust
Chester, , United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, , United Kingdom
Frimley Health NHS Foundation Trust
Frimley, , United Kingdom
Royal Surrey County Hospitals NHS Foundation Trust
Guildford, , United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , 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
North West Anglia NHS Foundation Trust
Peterborough, , 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
Frimley Health NHS Foundation Trust
Slough, , United Kingdom
Stockport NHS Foundation Trust
Stockport, , United Kingdom
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, , United Kingdom
Abertawe Bro Morannwg University Health Board
Swansea, , United Kingdom
Great Western Hospitals NHS Foundation Trust
Swindon, , United Kingdom
Taunton and Somerset NHS Foundation Trust
Taunton, , United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, , 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
Betsi Cadwaladr University Health Board
Wrexham, , United Kingdom
Yeovil District Hospital NHS Foundation Trust
Yeovil, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Sean Symons
Role: primary
James Murray
Role: primary
Raghuram Thonse
Role: primary
Oliver Templeton-Ward
Role: primary
Reza Mayahi
Role: primary
Barry Andrews
Role: primary
Pankaj Sharma
Role: primary
Jeremy Rushbrook
Role: primary
Leonidas Vachtsevanos
Role: primary
David Johnson
Role: primary
Andrew Kelly
Role: primary
Robin Kincaid
Role: primary
Jon Smith
Role: primary
Ben Coupe
Role: primary
Yeogesh Joshi
Role: primary
References
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Beard DJ, Davies L, Cook JA, Stokes J, Leal J, Fletcher H, Abram S, Chegwin K, Greshon A, Jackson W, Bottomley N, Dodd M, Bourke H, Shirkey BA, Paez A, Lamb SE, Barker KL, Phillips M, Brown M, Lythe V, Mirza B, Carr A, Monk P, Areia CM, O'Leary S, Haddad F, Wilson C, Price A; ACL SNNAP Study Group. Comparison of surgical or non-surgical management for non-acute anterior cruciate ligament injury: the ACL SNNAP RCT. Health Technol Assess. 2024 Jun;28(27):1-97. doi: 10.3310/VDKB6009.
Beard DJ, Davies L, Cook JA, Stokes J, Leal J, Fletcher H, Abram S, Chegwin K, Greshon A, Jackson W, Bottomley N, Dodd M, Bourke H, Shirkey BA, Paez A, Lamb SE, Barker K, Phillips M, Brown M, Lythe V, Mirza B, Carr A, Monk P, Morgado Areia C, O'Leary S, Haddad F, Wilson C, Price A; ACL SNNAP Study Group. Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial. Lancet. 2022 Aug 20;400(10352):605-615. doi: 10.1016/S0140-6736(22)01424-6.
Davies L, Cook J, Leal J, Areia CM, Shirkey B, Jackson W, Campbell H, Fletcher H, Carr A, Barker K, Lamb SE, Monk P, O'Leary S, Haddad F, Wilson C, Price A, Beard D. Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial. Trials. 2020 May 14;21(1):405. doi: 10.1186/s13063-020-04298-y.
Other Identifiers
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12096
Identifier Type: -
Identifier Source: org_study_id