STaR (Surgical Timing and Rehabilitation) Trial for Multiple Ligament Knee Injuries
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 690
- 试验地点
- 1
- 主要终点
- Patient-Reported Physical Function - Activity Limitation Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire
研究概览
简要总结
The purpose of this study is to investigate effects of timing of surgery (early vs. delayed) and timing of post-operative rehabilitation (early vs. delayed) for the treatment of military personnel and civilians that sustain a multiple ligament knee injury. To achieve this overall objective of this project, we will conduct two parallel randomized clinical trials. For the first study we will randomize individuals to timing of surgery and timing of post-operative rehabilitation. We hypothesize that early surgery, early rehabilitation and the combination of early surgery with early rehabilitation will lead to an earlier and more complete return to pre-injury military duty, work and sports and better patient-reported physical function. In the second study, those whose timing of surgery can not be randomized, will be only randomized to early or delayed rehabilitation. For this study, we hypothesize that early rehabilitation will lead to an earlier and more complete return to pre-injury military duty, work and sports activity and better patient-reported physical function.
详细描述
Background:
Multiple ligament knee injuries (MLKIs) represent a spectrum of injury ranging from disruption of two ligaments to all four major ligaments of the knee. Concomitant injuries may include fractures and injuries to vessels, nerves, tendons, menisci and/or articular cartilage. As such, the treatment of MLKIs creates multiple complex problems fraught with complications such as poor wound healing, arthrofibrosis, neurovascular injuries, persistent pain and instability, and post-traumatic osteoarthritis. Following MLKI, individuals are frequently limited with higher demand activities such as in military training, physical labor and sports. Return to duty after combat-related MLKIs has been reported to be as low as 41% and substantially lower than return to work reported for civilians.
There is controversy related to the optimal timing of surgery and post-operative rehabilitation for the treatment of MLKIs. Early surgical intervention for MLKIs has been advocated, however this may be associated with an increased risk for arthrofibrosis. Conversely, delayed surgery may be associated with persistent instability. The best evidence for timing of rehabilitation is based on evidence following ACL reconstruction, where early post-operative rehabilitation is the current standard of care. However, because of the frequency of soft tissue repair procedures, post-operative rehabilitation after surgery for a MLKI typically involves a period of non-WB and delayed ROM exercises. Due to the lack of evidence for the timing of surgery and post-operative rehabilitation, a large scale trial is needed to optimize the outcomes for these potentially devastating injuries. Therefore, this multicenter clinical trial will investigate the effects of timing of surgery and post-op rehabilitation to optimize return to military duty, work and sports for military personnel and civilians with a MLKI.
Objectives, Aims and Hypothesis:
The overall objective of this project is to investigate the effects of timing of surgery (early vs. delayed) and timing of post-op rehabilitation (early vs. delayed) for treatment of MLKIs. To achieve this objective, we will conduct two parallel randomized clinical trials. The related aims and hypotheses are:
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
盲法说明
These are unblinded trials as the participants will know when they are receiving surgery and when they are receiving rehabilitation. The data that are collected as part of the standard of care clinical follow-up will be recorded by the clinicians that know the participant's surgery assignment. The primary outcome and most of the secondary outcomes are patient self-report. Given that our interventions are either early or delayed surgery and/or rehabilitation, it is difficult for us to estimate the direction of potential bias (if any) that could come from the unblinded nature of this study.
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the clinical trials for both aims, male and female military personnel and civilians between the ages of 16 and 55 with a MLKI (defined as a complete grade III injury of two or more ligaments) will be eligible to participate. Individuals with a nerve injury or biceps or popliteus tendon rupture or avulsion will not be excluded from participation in either trial.
- •Individuals will be excluded from both trials if they:
- •Prior knee ligament surgery of the involved knee;
- •Torn or avulsed patellar or quadriceps tendon;
- •Periarticular or long bone fracture that is anticipated to preclude weight-bearing after surgery;
- •Require use of an external fixator for greater than 10 days;
- •Planned staged surgical treatment;
- •Unable to weight bear on the contralateral uninjured leg;
- •Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care;
- •Surgical procedures that precludes early weight-bearing or range of motion.
- •Any condition that would preclude the ability to comply with post-operative guidelines.
- •Additional Eligibility Criteria for Participation in Aim 1 - Randomization to Both Timing of Surgery and Post-Operative Rehabilitation
- •To be eligible to participate in the study for Aim 1 individuals with a MLKI must present to orthopaedic surgery in time to undergo definitive surgery within 6 weeks of injury if randomized to the early surgery group.
- •Individuals will also be ineligible to participate in the study for Aim 1 if they have:
- •Vascular injury that dictates timing of surgery;
- •Poly trauma that precludes surgery within 6 weeks of injury;
- •Skin or soft tissue injury that precludes early surgery and rehabilitation.
- •Additional Eligibility Criteria for Participation in Aim 2 - Randomization to Only timing of Post-operative Rehabilitation
- •Subjects with a MLKI that present to orthopaedic surgery at a time that precludes randomization to early surgery or have an injury that precludes randomizing the timing of surgery (such as a vascular injury) as well as those that refuse randomization to the timing of surgery will be eligible to participate in the study for Aim 2 which randomizes subjects to only early vs. delayed rehabilitation.
- •Individuals will also be excluded from the trial that randomizes only the timing post-operative rehabilitation if they have:
- •Vascular surgery that precludes early rehabilitation;
- •Polytrauma that limits ability to participate in post-operative care;
- •Skin or soft tissue injury that precludes early rehabilitation
排除标准
- 未提供
研究组 & 干预措施
Early Surgery & Early Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to early surgery and early rehabilitation.
干预措施: Early Surgery (Procedure)
Early Surgery & Early Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to early surgery and early rehabilitation.
干预措施: Early Rehab (Procedure)
Early Surgery & Delayed Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to early surgery and delayed rehabilitation.
干预措施: Early Surgery (Procedure)
Early Surgery & Delayed Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to early surgery and delayed rehabilitation.
干预措施: Delayed Rehab (Procedure)
Delayed Surgery & Early Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to delayed surgery and early rehabilitation.
干预措施: Delayed Surgery (Procedure)
Delayed Surgery & Early Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to delayed surgery and early rehabilitation.
干预措施: Early Rehab (Procedure)
Delayed Surgery & Delayed Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to delayed surgery and delayed rehabilitation.
干预措施: Delayed Surgery (Procedure)
Delayed Surgery & Delayed Rehab
Individuals with a MLKI that present within 6 weeks of injury will be randomized to delayed surgery and delayed rehabilitation.
干预措施: Delayed Rehab (Procedure)
Early Rehab Only
Individuals not eligible for randomization to timing of surgery will be randomized to only early rehabilitation.
干预措施: Early Rehab (Procedure)
Delayed Rehab Only
Individuals not eligible for randomization to timing of surgery will be randomized to only delayed rehabilitation.
干预措施: Delayed Rehab (Procedure)
结局指标
主要结局
Patient-Reported Physical Function - Activity Limitation Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire
时间窗: 24 months following randomization
Activity Limitation Scale of the Multiple Ligament Quality of Life scale measures the degree of difficulty an individual with a multiple ligament knee injury experiences with simple and complex activities as related to his/her knee. The Activity Limitation Scale score ranges from 0 to 100 with a score of 0 representing no activity limitations due to the multiple ligament knee injury.
Time to Return to Pre-Injury Level of Activity
时间窗: Monthly starting at 6 months post-randomization and continuing to 24 months
Time to return to pre-injury level military duty, work and/ sports
次要结局
- Social Involvement Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire(24 months following randomization)
- Patient Reported Outcome Measurement Information System (PROMIS) Global 1- Global 10(24 months following randomization)
- Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Scale(24 months following randomization)
- Emotional Impairment Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire(24 months following randomization)
- Global Rating of Change (GRC)(24 months following randomization)
- Physical Impairment Scale of the Multiple Ligament Quality of Life (MLQoL) Questionnaire.(24 months following randomization)
- International Knee Documentation Committee Subjective Knee Form (IKDC-SKF)(24 months following randomization)
- Patient Acceptable Symptom State (PASS)(24 months following randomization)
研究者
James J. Irrgang
Professor and Chair, Department of Physical Therapy
University of Pittsburgh