Non- vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction
Non-Weight Bearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Multiple Knee Ligament Reconstruction: A Randomized Controlled Trial
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.
研究概览
详细说明
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.
The current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing for the first six weeks after surgery.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Kayla Seiffert
- 电话号码：952-456-7085
- 邮箱：research@tcomn.com
研究联系人备份
- 姓名：Becky McGaver
- 电话号码：952-456-7136
- 邮箱：research@tcomn.com
学习地点
-
-
Minnesota
-
Edina、Minnesota、美国、55435
- 招聘中
- Twin Cities Orthopedics
-
接触：
- Becky Stone
- 电话号码：952-456-7136
- 邮箱：research@tcomn.com
-
首席研究员：
- Robert F LaPrade, MD, PhD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ≥ 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.
Exclusion Criteria:
- < 14 years old
- >60 years old
- Pregnant
- Revision PCL reconstructions
- Previous or concurrent vascular injury (vascular bypass procedure)
- Associated fractures requiring concurrent surgery
- Concurrent meniscal root or radial repair surgery
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Non-weightbearing for the first six weeks after surgery
Not weightbearing after surgery |
Patient is randomized to the weightbearing group the day after surgery. |
|
实验性的：Partial weight -bearing for the first six weeks after surgery
Partial weightbearing will be defined as 40% of the patient's body weight. |
Patient is randomized to the weightbearing group the day after surgery. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gapping (mm) measured on Standard of Care Varus stress radiographs
大体时间：Pre-operative
|
stress radiographs |
Pre-operative
|
|
Gapping (mm) measured on Standard of Care Varus stress radiographs
大体时间：6 months post-surgery
|
stress radiographs |
6 months post-surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Numeric Pain Scale (NPS) (0-10 rating)
大体时间：Baseline and 6 months
|
Pain scale 0-100 |
Baseline and 6 months
|
|
Measurements by physical therapists (Edema, thigh circumference)
大体时间：4,7, and 10 months after surgery
|
Measurements with tape |
4,7, and 10 months after surgery
|
|
Measurements by physical therapists (Quadriceps strength, gait analysis)
大体时间：4,7, and 10 months after surgery
|
Measurements by biomechanics lab |
4,7, and 10 months after surgery
|
|
Patient reported outcome scores
大体时间：Baseline, 3 months, 6 months, 1 year
|
Surveys: International Knee Documentation Committee (IKDC), Cincinnati Knee Rating System (Cincinnati), Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner, Lysholm Knee Scoring Scale (Lysholm), and Veterans Rand 12 (VR-12) or Short Form-12 (SF-12) General Health Survey, lower extremity functional scale, Sports Medicine Questionnaire and survey/patient satisfaction |
Baseline, 3 months, 6 months, 1 year
|
|
Measurements by physical therapists (range of motion)
大体时间：4,7, and 10 months after surgery
|
Measurements with goniometer |
4,7, and 10 months after surgery
|
合作者和调查者
调查人员
- 首席研究员：Robert F LaPrade, MD, PhD、Twin Cities Orthopedics
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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