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ACL SNNAP Trial: ACL Surgery Necessity in Non Acute Patients (ACL SNNAP)

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ClinicalTrials.gov Identifier: NCT02980367
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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].

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Other: Non-Surgical Management (Rehabilitation) Procedure: Surgical Management (Reconstruction) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : December 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACL Rehabilitation Group
Non-surgical management [Rehabilitation] with option for later Anterior Cruciate Ligament (ACL) reconstruction, only if required.
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.
Other Names:
  • Physical Therapy
  • Physiotherapy
  • Conservative Rehabilitation
  • Conservative Management

Active Comparator: ACL Reconstruction Group
Surgical Management - Anterior Cruciate Ligament (ACL) reconstruction surgery
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.
Other Names:
  • ACL Reconstruction
  • ACLR
  • ACL surgery
  • Anterior Cruciate Ligament Surgery
  • Surgical Management




Primary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS4) [ Time Frame: 18 months post randomisation ]
    The score is derived from 4 of 5 subscales; pain, symptoms, difficulty in sports and recreational activities, knee related quality of life.


Secondary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: At baseline and at 6, 12 and 18 months post randomisation ]

    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)


  2. Modified Tegner scale [ Time Frame: At baseline and at 6, 12 and 18 months post randomisation ]
    Activity level will be assessed using the Modified Tegner scale, graded from 1 (low activity levels) to 10 (professional level).

  3. Intervention related complications [ Time Frame: At 6, 12 and 18 months post randomisation ]
    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.

  4. EuroQol EQ-5D-5L [ Time Frame: At baseline and at 6, 12 and 18 months post randomisation ]
    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).

  5. Resource-usage data [ Time Frame: 18 months post randomisation ]
    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).

  6. Anterior Cruciate Ligament Quality of Life score (ACL-QOL) [ Time Frame: At baseline and at 6, 12 and 18 months post randomisation ]
    Expectations of return to activity and confidence in relation to the knee.

  7. Patient satisfaction [ Time Frame: At baseline and at 6, 12 and 18 months post randomisation ]
    Simple Likert scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980367


Contacts
Contact: Carlos Areia 01865 223487 ACL_SNNAP@ndorms.ox.ac.uk

Locations
United Kingdom
Betsi Cadwaladr University Health Board Recruiting
Bangor, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust Recruiting
Cheltenham, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust Recruiting
Coventry, United Kingdom
Frimley Health NHS Foundation Trust Recruiting
Frimley, United Kingdom
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom
University Hospitals of Leicester Recruiting
Leicester, United Kingdom
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, United Kingdom
North West Anglia NHS Foundation Trust Recruiting
Peterborough, United Kingdom
Royal Berkshire NHS Foundation Trust Recruiting
Reading, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, United Kingdom
Frimley Health NHS Foundation Trust Recruiting
Slough, 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
Warrington and Halton Hospitals NHS Foundation Trust Recruiting
Warrington, United Kingdom
Yeovil District Hospital NHS Foundation Trust Recruiting
Yeovil, United Kingdom
Sponsors and Collaborators
University of Oxford

Additional Information:
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02980367     History of Changes
Other Study ID Numbers: 12096
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Oxford:
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

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries