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

This study is currently recruiting participants.
Verified April 2017 by University of Oxford
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980367
First Posted: December 2, 2016
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Oxford
  Purpose
The primary objective of this study is to determine in patients with non-acute (greater than 4 months since injury) 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 Intervention
Anterior Cruciate Ligament Injury Other: Non-Surgical Management (Rehabilitation) Procedure: Surgical Management (Reconstruction)

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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:
  • 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)


  • 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).

  • 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.

  • 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).

  • 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).

  • 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.

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


Estimated Enrollment: 320
Actual Study Start Date: December 2016
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 (greater than 4 months since injury) 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. 20 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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 (instability-episodes of frank giving way or feeling unstable) with ACL deficiency confirmed using clinical assessment and MRI scan.

Exclusion Criteria:

  • Less than 4 months since injury,
  • Previous knee surgery (other than diagnostic arthroscopy) to index knee, concomitant severe injury to contra-lateral knee,
  • Meniscal pathology considered sufficiently symptomatic to require surgery i.e. locked knee, large bucket handle cartilage tear.
  • 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.
  Contacts and Locations
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 227715 ACL_SNNAP@ndorms.ox.ac.uk

Locations
United Kingdom
Morriston Hospital Recruiting
Swansea, United Kingdom
Great Western Hospitals Recruiting
Swindon, United Kingdom
Sponsors and Collaborators
University of Oxford
  More Information

Additional Information:
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02980367     History of Changes
Other Study ID Numbers: 12096
First Submitted: November 17, 2016
First Posted: December 2, 2016
Last Update Posted: April 10, 2017
Last Verified: April 2017
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