ACL SNNAP Trial: ACL Surgery Necessity in Non Acute Patients

NCT02980367 | Unknown DMC

• 1 other identifier: 12096
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 32

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 \[Reconstruction\].

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  At baseline and at 6, 12 and 18 months post randomisation

• Modified Tegner scale

  At baseline and at 6, 12 and 18 months post randomisation

• Intervention related complications

  At 6, 12 and 18 months post randomisation

• EuroQol EQ-5D-5L

  At baseline and at 6, 12 and 18 months post randomisation

• Resource-usage data

  18 months post randomisation

Study Arms (2)

ACL Rehabilitation Group

EXPERIMENTAL

Non-surgical management \[Rehabilitation\] with option for later Anterior Cruciate Ligament (ACL) reconstruction, only if required.

Other: Non-Surgical Management (Rehabilitation)

ACL Reconstruction Group

ACTIVE COMPARATOR

Surgical Management - Anterior Cruciate Ligament (ACL) reconstruction surgery

Procedure: Surgical Management (Reconstruction)

Interventions

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.

Also known as: Physical Therapy, Physiotherapy, Conservative Rehabilitation, Conservative Management

ACL Rehabilitation Group

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.

Also known as: ACL Reconstruction, ACLR, ACL surgery, Anterior Cruciate Ligament Surgery, Surgical Management

ACL Reconstruction Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (32)

Betsi Cadwaladr University Health Board

Bangor, United Kingdom

RECRUITING

Basildon and Thurrock University Hospitals NHS Foundation Trust

Basildon, United Kingdom

RECRUITING

North Bristol NHS Trust

Bristol, United Kingdom

RECRUITING

Gloucestershire Hospitals NHS Foundation Trust

Cheltenham, United Kingdom

RECRUITING

Countess of Chester Hospital NHS Foundation Trust

Chester, United Kingdom

RECRUITING

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

RECRUITING

Frimley Health NHS Foundation Trust

Frimley, United Kingdom

RECRUITING

Royal Surrey County Hospitals NHS Foundation Trust

Guildford, United Kingdom

RECRUITING

Hull and East Yorkshire Hospitals NHS Trust

Hull, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

RECRUITING

University Hospitals of Leicester

Leicester, United Kingdom

RECRUITING

Kings College Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, United Kingdom

RECRUITING

Manchester University NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

RECRUITING

North West Anglia NHS Foundation Trust

Peterborough, United Kingdom

RECRUITING

Portsmouth Hospitals NHS Trust

Portsmouth, United Kingdom

RECRUITING

Royal Berkshire NHS Foundation Trust

Reading, United Kingdom

RECRUITING

Salisbury NHS Foundation Trust

Salisbury, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

RECRUITING

Frimley Health NHS Foundation Trust

Slough, United Kingdom

RECRUITING

Stockport NHS Foundation Trust

Stockport, United Kingdom

RECRUITING

Sherwood Forest Hospitals NHS Foundation Trust

Sutton in Ashfield, United Kingdom

RECRUITING

Abertawe Bro Morannwg University Health Board

Swansea, United Kingdom

RECRUITING

Great Western Hospitals NHS Foundation Trust

Swindon, United Kingdom

RECRUITING

Taunton and Somerset NHS Foundation Trust

Taunton, United Kingdom

RECRUITING

Royal Cornwall Hospitals NHS Trust

Truro, United Kingdom

RECRUITING

The Mid Yorkshire Hospitals NHS Trust

Wakefield, United Kingdom

RECRUITING

Warrington and Halton Hospitals NHS Foundation Trust

Warrington, United Kingdom

RECRUITING

Wrightington, Wigan and Leigh NHS Foundation Trust

Wigan, United Kingdom

RECRUITING

Betsi Cadwaladr University Health Board

Wrexham, United Kingdom

RECRUITING

Yeovil District Hospital NHS Foundation Trust

Yeovil, United Kingdom

RECRUITING

Related Publications (3)

• 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.

  PMID: 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 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.

  PMID: 35988569 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.

  PMID: 32410697 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Rehabilitation; Physical Therapy Modalities; Conservative Treatment; Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Surgical Procedures, Operative

Study Officials

• David Beard, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Beard

CONTACT

01865 737210; ACL_SNNAP@ndorms.ox.ac.uk

Loretta Davies

CONTACT

01865737210; loretta.davies@ndorms.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 2, 2016
• Study Start: December 1, 2016
• Primary Completion: November 1, 2021
• Study Completion: March 1, 2022
• Last Updated: October 15, 2021

Record last verified: 2020-11

Locations

GB (32)