Better and Safer Return to Sport After Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Return to sport
研究概览
简要总结
A prospective cohort design will be used to assess differences in outcomes between pivoting sport athletes with anterior cruciate ligament reconstruction (ACLR) who follow usual care and those who follow a treatment algorithm with a RTS and rehabilitation tool. Athletes aged 15-40 at injury with primary ACLR who express a goal to return to sports with frequent pivoting are eligible. The RTS and rehabilitation tool includes standardized clinical, functional and muscle strength testing 6, 8, 10, and 12 months after surgery. Individual test results guide progression in sports participation and the content of further rehabilitation according to a standardized algorithm.
详细描述
Fewer than half of athletes with ACLR return to competitive sports, and, for those who return, 1 in 5 sustain reinjury. Insufficient functional recovery and poor psychological readiness to RTS are thought to contribute to these low RTS rates and high reinjury rates. Previous research has shown that return to sport (RTS) should be delayed until the athlete passes the criteria of a clinical decision-making tool for RTS. However, to successfully improve RTS and reinjury outcomes, it is imperative that a decision-making tool (1) guides RTS decisions at a specific point in time, and (2) directs the planning and execution of treatments that eventually enable the athlete to safely RTS.
Nonprofessional athletes are often discharged from rehabilitation prior to RTS, and most are treated by rehabilitation clinicians who do not have access to the sophisticated and expensive test equipment used in previous research on functional readiness for RTS. The RTS and rehabilitation tool is therefore designed in collaboration with athletes, coaches and primary care physical therapists as a low-cost intervention that is feasible to implement on a broad scale.
The athletes who follow the RTS and rehabilitation tool will be recruited from Oslo, Norway, while the control group that receives usual care will be recruited from the Swedish Knee Ligament register (SPARX study Dnr 2019-04546).
Predefined adjustment factors for the comparative analyses are: age, sex, specific preinjury sport, family history of ACL injury, time from injury to surgery, meniscal and cartilage injury at ACLR, meniscal repair, and ACL graft type. The analysis of reinjury will be adjusted for sports exposure.
Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary anterior cruciate ligament reconstruction 6 months ago (+- 2 weeks)
- •age 15-40 years at the time of anterior cruciate ligament injury
- •preinjury participation in level I pivoting sport at least 2 times per week
- •expressed goal to return to level I sport
排除标准
- •grade 3 injury to the medial collateral ligament, lateral collateral ligament, or posterior cruciate ligament
- •contralateral ACL tear
- •inability to understand the native language in the country of recruitment
- •other serious injury or illness that impairs function
- •has access to specialist sports medicine care (e.g., health support from national team) not accessible to all athletes
- •derives primary income from sports participation
- •member of sports health team present at the majority of the team's training sessions
结局指标
主要结局
Return to sport
时间窗: 2 years after ACLR
Participation in preinjury sport (yes/no)
Reinjury
时间窗: 2 years after ACLR
Injury to the ACL, medial or lateral meniscus in the ipsi- and contralateral knee (yes/no)
次要结局
- Adherence/fidelity to the intervention(Monthly self-report 7-14 months after ACLR)
- International knee documentation committee subjective knee form(2 years after ACLR)
- Anterior cruciate ligament return to sport after injury(2 years after ACLR)
- Barriers and motivating factors for adherence to the intervention(14 months after ACLR)
研究者
Hege Grindem
Associate professor
Norwegian School of Sport Sciences