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康复前六周的完全负重与部分负重。腓侧副韧带重建术后

2026年10月1日 更新者:Twin Cities Orthopedics

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

地位

招聘中

条件

详细说明

Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:

  1. partial weightbearing
  2. 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

  1. 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.
  2. 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

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Minnesota
      • Edina、Minnesota、美国、55435
        • 招聘中
        • Twin Cities Orthopedics
        • 接触:
        • 首席研究员:
          • Robert F LaPrade, MD, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 至 59年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Robert F LaPrade, MD, PhD、Twin Cities Orthopedics

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年1月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2021年9月14日

首先提交符合 QC 标准的

2021年9月28日

首次发布 (实际的)

2021年10月11日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • RFL_FWB vs PWB-FCL

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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