ACL SNNAP Trial: ACL Surgery Necessity in Non Acute Patients

Anterior Cruciate Ligament Injury Clinical Trial

— ACL SNNAP  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02980367
• Other study ID #: 12096
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: March 2022

Study information

• Verified date: November 2020
• Source: University of Oxford
• Contact: David Beard
• Phone: 01865 737210
• Email: ACL_SNNAP[@]ndorms.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

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 information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: March 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury

Intervention

Other:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Modified Tegner scale	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient satisfaction	Simple Likert scale	At baseline and at 6, 12 and 18 months post randomisation

External Links

•   ACL SNNAP Trial website