Comparison of the Clinical and Cost Effectiveness of Two Management Strategies for Non-acute Anterior Cruciate Ligament (ACL) Injury: Rehabilitation Versus Surgical Reconstruction.
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 32
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS4)
研究概览
简要总结
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].
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS4)
时间窗: 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.
次要结局
- Modified Tegner scale(At baseline and at 6, 12 and 18 months post randomisation)
- Resource-usage data(18 months post randomisation)
- Anterior Cruciate Ligament Quality of Life score (ACL-QOL)(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)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(At baseline and at 6, 12 and 18 months post randomisation)
- Patient satisfaction(At baseline and at 6, 12 and 18 months post randomisation)