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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].
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACL Rehabilitation Group | Experimental | Non-surgical management [Rehabilitation] with option for later Anterior Cruciate Ligament (ACL) reconstruction, only if required. |
|
| ACL Reconstruction Group | Active Comparator | Surgical Management - Anterior Cruciate Ligament (ACL) reconstruction surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Surgical Management (Rehabilitation) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS4) | The score is derived from 4 of 5 subscales; pain, symptoms, difficulty in sports and recreational activities, knee related quality of life. | 18 months post randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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) | At baseline and at 6, 12 and 18 months post randomisation |
| Modified Tegner scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Beard | Contact | 01865 737210 | ACL_SNNAP@ndorms.ox.ac.uk | |
| Loretta Davies | Contact | 01865737210 | loretta.davies@ndorms.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| David Beard, DPhil | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Betsi Cadwaladr University Health Board | Recruiting | Bangor | United Kingdom | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38940695 | Derived | 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. | |
| 35988569 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 28, 2024 | |
| Reset | Sep 20, 2024 |
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|
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| Surgical Management (Reconstruction) | Procedure | 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. |
|
|
Activity level will be assessed using the Modified Tegner scale, graded from 1 (low activity levels) to 10 (professional level). |
| At baseline and at 6, 12 and 18 months post randomisation |
| Intervention related complications | 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. | At 6, 12 and 18 months post randomisation |
| EuroQol EQ-5D-5L | 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). | At baseline and at 6, 12 and 18 months post randomisation |
| Resource-usage data | 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). | 18 months post randomisation |
| Anterior Cruciate Ligament Quality of Life score (ACL-QOL) | Expectations of return to activity and confidence in relation to the knee. | At baseline and at 6, 12 and 18 months post randomisation |
| Patient satisfaction | Simple Likert scale | At baseline and at 6, 12 and 18 months post randomisation |
| Basildon and Thurrock University Hospitals NHS Foundation Trust |
| Recruiting |
| Basildon |
| United Kingdom |
|
| North Bristol NHS Trust | Recruiting | Bristol | United Kingdom |
|
| Gloucestershire Hospitals NHS Foundation Trust | Recruiting | Cheltenham | United Kingdom |
| Countess of Chester Hospital NHS Foundation Trust | Recruiting | Chester | United Kingdom |
|
| University Hospitals Coventry and Warwickshire NHS Trust | Recruiting | Coventry | United Kingdom |
| Frimley Health NHS Foundation Trust | Recruiting | Frimley | United Kingdom |
| Royal Surrey County Hospitals NHS Foundation Trust | Recruiting | Guildford | United Kingdom |
|
| Hull and East Yorkshire Hospitals NHS Trust | Recruiting | Hull | United Kingdom |
|
| Leeds Teaching Hospitals NHS Trust | Recruiting | Leeds | United Kingdom |
| University Hospitals of Leicester | Recruiting | Leicester | United Kingdom |
| Kings College Hospital NHS Foundation Trust | Recruiting | London | United Kingdom |
|
| University College London Hospitals NHS Foundation Trust | Recruiting | London | United Kingdom |
| Manchester University NHS Foundation Trust | Recruiting | Manchester | United Kingdom |
|
| Oxford University Hospitals NHS Foundation Trust | Recruiting | Oxford | United Kingdom |
| North West Anglia NHS Foundation Trust | Recruiting | Peterborough | United Kingdom |
| Portsmouth Hospitals NHS Trust | Recruiting | Portsmouth | United Kingdom |
|
| Royal Berkshire NHS Foundation Trust | Recruiting | Reading | United Kingdom |
| Salisbury NHS Foundation Trust | Recruiting | Salisbury | United Kingdom |
|
| Sheffield Teaching Hospitals NHS Foundation Trust | Recruiting | Sheffield | United Kingdom |
| Frimley Health NHS Foundation Trust | Recruiting | Slough | United Kingdom |
| Stockport NHS Foundation Trust | Recruiting | Stockport | United Kingdom |
|
| Sherwood Forest Hospitals NHS Foundation Trust | Recruiting | Sutton in Ashfield | United Kingdom |
| Abertawe Bro Morannwg University Health Board | Recruiting | Swansea | United Kingdom |
| Great Western Hospitals NHS Foundation Trust | Recruiting | Swindon | United Kingdom |
| Taunton and Somerset NHS Foundation Trust | Recruiting | Taunton | United Kingdom |
|
| Royal Cornwall Hospitals NHS Trust | Recruiting | Truro | United Kingdom |
|
| The Mid Yorkshire Hospitals NHS Trust | Recruiting | Wakefield | United Kingdom |
|
| Warrington and Halton Hospitals NHS Foundation Trust | Recruiting | Warrington | United Kingdom |
| Wrightington, Wigan and Leigh NHS Foundation Trust | Recruiting | Wigan | United Kingdom |
|
| Betsi Cadwaladr University Health Board | Recruiting | Wrexham | United Kingdom |
|
| Yeovil District Hospital NHS Foundation Trust | Recruiting | Yeovil | United Kingdom |
| Derived |
| 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. |
| 32410697 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 28, 2024 | Sep 20, 2024 |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D026741 | Physical Therapy Modalities |
| D000072700 | Conservative Treatment |
| D019651 | Plastic Surgery Procedures |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D013514 | Surgical Procedures, Operative |
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