Non-Weight Bearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Multiple Knee Ligament Reconstruction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Gapping (mm) measured on Standard of Care Varus stress radiographs
研究概览
简要总结
This is a prospective randomized controlled trial with the purpose to determine if patients undergoing isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL), posterolateral corner (PLC), and MCL reconstructions (or any combination of multiple ligaments) can safely begin partial controlled weightbearing for the first six weeks after surgery.
详细描述
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:
- non-weightbearing
- partial weightbearing
An immobilizer brace in extension will be used from post-operative day 0 through 4 and a dynamic stabilizing posterior knee brace (Ossur) will be used from 5 days through 6 months post-surgery to protect against increased posterior translation forces due to gravity and while weightbearing for patients with PCL reconstructions.
Specific Aims
- Primary Aim: To determine if there is clinical equivalence in millimeters of posterior tibial translation on posterior stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
- Primary Aim: To determine if there is clinical equivalence in millimeters of valgus and/or varus compartment gapping on stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
- Secondary Aim: To determine if there is a difference in pain, edema, range of motion, gait, and quadriceps strength between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 14 years old, <60
- •Reconstruction of PCL alone
- •Reconstruction of MCL alone
- •Reconstruction of combined multiligament injuries (PCL+ (FCL, PLC, ACL, MCL))
- •Reconstruction of multiligament injuries (ACL+MCL)
- •Males or females
- •Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
排除标准
- •< 14 years old
- •>60 years old
- •Revision PCL reconstructions
- •Previous or concurrent vascular injury (vascular bypass procedure)
- •Associated fractures requiring concurrent surgery
- •Concurrent meniscal root or radial repair surgery
结局指标
主要结局
Gapping (mm) measured on Standard of Care Varus stress radiographs
时间窗: 6 months post-surgery
stress radiographs
次要结局
- Measurements by physical therapists (range of motion)(4,7, and 10 months after surgery)
- Numeric Pain Scale (NPS) (0-10 rating)(Baseline and 6 months)
- Measurements by physical therapists (Edema, thigh circumference)(4,7, and 10 months after surgery)
- Measurements by physical therapists (Quadriceps strength, gait analysis)(4,7, and 10 months after surgery)
- Patient reported outcome scores(Baseline, 3 months, 6 months, 1 year)