康复前六周的完全负重与部分负重。腓侧副韧带重建术后
Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: A Randomized Controlled Trial
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.
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:
- 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.
The Investigators hypothesize that there will be no clinically significant difference (< 2 mm change) in varus gapping between the control and treatment groups. Results of this study will help to expedite return to pre-injury levels of activity and decrease adverse sequelae associated with non-weight bearing such as osteopenia, muscle atrophy, loss of ankle range of motion, and increased risk of deep vein thrombosis.
The current standard of care for FCL reconstruction is early controlled partial weight -bearing 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:Becky Stone
- 电话号码:952-456-7136
- 邮箱:research@tcomn.com
研究联系人备份
- 姓名:Kayla Seiffert
- 电话号码:952-456-7085
- 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 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.
Exclusion Criteria:
- < 14 years old, > 60
- Pregnant
- 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
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: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. |
|
实验性的:Full weight -bearing for the first six weeks after surgery
If the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities. |
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 radiograph |
Pre-operative
|
|
Gapping (mm) measured Standard of Care Varus stress radiographs
大体时间:6 months post-surgery
|
stress radiograph |
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 (Range of Motion)
大体时间:4,7, and 10 months after surgery
|
Measurements with goniometer |
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
|
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
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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