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临床试验/NCT06636045
NCT06636045Enrolling By Invitation不适用

Effect of Blood Flow Restriction (BFR) on Rehabilitation Protocols Following Anterior Cruciate Ligament Reconstruction (ACLR) With Quadricep Autograft

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
1
主要终点
Quad muscle Strength

研究概览

简要总结

This project is intended to acquire objective measurements of implementing BFR rehabilitation in ACL reconstructions to show any changes upon completion of the BFR protocol. The results in this study will hopefully represent valuable data in the support of using autografts for ACL reconstructions in high level athletes wanting a full recovery and return to high level of sport.

It has been speculated that use of autografts in ACL reconstructions leads to more quad weakness and muscle atrophy due to tendon harvesting. (Slone et al., 2015) More recently, BFR has shown promise in expediting the recovery and rehabilitation process post-surgically. By implementing BFR following ACL reconstructions with autografts, we hope to mitigate the major deterrent for autograft use and giving patients a more cost-effective approach to surgery. (Hughes et al., 2019)

详细描述

Specific Aim 1 will identify the overall preservation of muscle and changes in body composition after injury and throughout surgical rehabilitation in athletes undergoing ACL reconstruction. It is hypothesized that implementing BFR rehabilitation protocols following ACL reconstruction with autografts will expedite recovery and return to sport and rescue of muscle tissue at the donor site.

Specific Aim 2 will monitor muscle strength and activation following ACL reconstruction with performance of standardized assessments at intervals. It is hypothesized that BFR implementation will show greater return to strength and enhanced muscle activation during testing.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient undergoing anterior cruciate ligament construction utilizing a quadriceps autograft
  • Age 14 - 40 years old

排除标准

  • Comorbid conditions (i.e.: hypertension, diabetes, obesity, etc.)
  • Patient taking blood thinners or at risk of embolism
  • Revision anterior cruciate ligament construction
  • Allograft based reconstruction
  • Non-quadriceps graft

结局指标

主要结局

Quad muscle Strength

时间窗: At 6 week post surgical timepoints

Compare the muscle strength gain or loss between BFR group and control group

Return to sport

时间窗: 6 week intervals

Compare the time it takes participants to return to sport in BFR group to control group

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Vopat

Assistant Professor, Orthopedic Surgery

University of Kansas Medical Center

研究点 (1)

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