Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: 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 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 fibular collateral ligament (FCL) reconstruction alone or combined FCL and anterior cruciate ligament (ACL) reconstructions can safely begin full 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:
- partial weightbearing
- full controlled weightbearing
An immobilizer brace in extension will be used from post-operative day 0 through 13 and a CTi ligament knee brace (Össur Americas, Foothill Ranch, California) will be used from 14 to 42 days post-surgery to protect against side-to-side motion while weight bearing.
Specific Aims
- Primary Aim: To determine if there is a difference in millimeters of varus gapping on anteroposterior (AP) stress radiographs at six months post-surgery between patients who are partial weight bearing versus full controlled weight bearing during the first six weeks of post-surgical rehabilitation. This distance will be compared to varus gapping measured on the contralateral uninjured control knee.
- Secondary Aim: To determine if there is a difference in pain, edema, and range of motion, gait, quadriceps strength, and patient reported outcomes 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 FCL alone
- •Combined FCL + ACL reconstructions
- •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
- •Revision FCL reconstructions
- •Concurrent biceps femoris or lateral capsular repairs
- •Concurrent PCL or MCL reconstructions
- •Concomitant meniscus root or radial repair surgery with transtibial technique
结局指标
主要结局
Gapping (mm) measured Standard of Care Varus stress radiographs
时间窗: 6 months post-surgery
stress radiograph
Gapping (mm) measured on Standard of Care Varus stress radiographs
时间窗: Pre-operative
stress radiograph
次要结局
- Numeric Pain Scale (NPS) (0-10 rating)(Baseline and 6 months)
- Measurements by physical therapists (Range of Motion)(4,7, and 10 months after surgery)
- Patient reported outcome scores(Baseline, 3 months, 6 months, 1 year)
- 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)