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 : April 10, 2017
|Condition or disease||Intervention/treatment|
|Anterior Cruciate Ligament Injury||Other: Non-Surgical Management (Rehabilitation) Procedure: Surgical Management (Reconstruction)|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980367
|Contact: Carlos Areia||01865 227715||ACL_SNNAP@ndorms.ox.ac.uk|
|Swansea, United Kingdom|
|Great Western Hospitals||Recruiting|
|Swindon, United Kingdom|