Clinical trial NCT02980367: ACL SNNAP Trial: ACL Surgery Necessity in Non Acute Patients
Official title: Comparison of the Clinical and Cost Effectiveness of Two Management Strategies for Non-acute Anterior Cruciate Ligament (ACL) Injury: Rehabilitation Versus Surgical Reconstruction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Keywords: Anterior Cruciate Ligament
ACL
Anterior Cruciate Ligament deficiency
ACL deficiency
ACLD
Anterior Cruciate Ligament reconstruction
ACL reconstruction
Anterior Cruciate Ligament physiotherapy
Anterior Cruciate Ligament rehabilitation
ACL physiotherapy
ACL rehabilitation
Anterior Cruciate Ligament management
ACL management
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS4)
timeFrame: 18 months post randomisation
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At baseline and at 6, 12 and 18 months post randomisation
measure: Modified Tegner scale
timeFrame: At baseline and at 6, 12 and 18 months post randomisation
measure: Intervention related complications
timeFrame: At 6, 12 and 18 months post randomisation
measure: EuroQol EQ-5D-5L
timeFrame: At baseline and at 6, 12 and 18 months post randomisation
measure: Resource-usage data
timeFrame: 18 months post randomisation
measure: Anterior Cruciate Ligament Quality of Life score (ACL-QOL)
timeFrame: At baseline and at 6, 12 and 18 months post randomisation
measure: Patient satisfaction
timeFrame: At baseline and at 6, 12 and 18 months post randomisation
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
facility: Betsi Cadwaladr University Health Board
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock University Hospitals NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Cheltenham
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital NHS Foundation Trust
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
city: Frimley
country: United Kingdom
facility: Frimley Health NHS Foundation Trust
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospitals NHS Foundation Trust
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Peterborough
country: United Kingdom
facility: North West Anglia NHS Foundation Trust
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
city: Salisbury
country: United Kingdom
facility: Salisbury NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Slough
country: United Kingdom
facility: Frimley Health NHS Foundation Trust
city: Stockport
country: United Kingdom
facility: Stockport NHS Foundation Trust
city: Sutton In Ashfield
country: United Kingdom
facility: Sherwood Forest Hospitals NHS Foundation Trust
city: Swansea
country: United Kingdom
facility: Abertawe Bro Morannwg University Health Board
city: Swindon
country: United Kingdom
facility: Great Western Hospitals NHS Foundation Trust
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
city: Wakefield
country: United Kingdom
facility: The Mid Yorkshire Hospitals NHS Trust
city: Warrington
country: United Kingdom
facility: Warrington and Halton Hospitals NHS Foundation Trust
city: Wigan
country: United Kingdom
facility: Wrightington, Wigan and Leigh NHS Foundation Trust
city: Wrexham
country: United Kingdom
facility: Betsi Cadwaladr University Health Board
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital NHS Foundation Trust
Study officials:
affiliation: University of Oxford
name: David Beard, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.