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临床试验/NCT05396521
NCT05396521已完成不适用

Utilizing Blood Flow Restriction Therapy Following ORIF Treated Distal Radius Fractures

Carilion Clinic2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2022年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
PROMIS Pain interference SF V1.1

研究概览

简要总结

This study's goal is to evaluate whether blood flow restriction supplemented therapy is a superior therapy compared to traditional standard of care while recovering from a surgery that repairs distal radius fractures. In order to measure this, subjects will be randomly assigned to either the traditional therapy group (with standard of care) or a blood flow restriction supplemented therapy group. All patients involved in this study will have had a distal radius fracture that is repaired with a technique called volar plating and the procedure will be done via an open technique. All subjects will be asked to fill out questionnaires that assess their pain and wrist functionality throughout the course of the study. These measurements will help understand whether the supplemented therapy is effective at reducing pain and improving functionality for patients who are recovering from this injury.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Outpatients undergoing distal radius fracture open reduction internal fixation using volar plating (CPT 25607, 25608, and 25609)
  • Age 50 - 75
  • Fall onto outstretched hand injury

排除标准

  • High energy mechanism
  • Fall from an elevated position greater than 12 inches
  • Motor vehicle collision
  • Any activity involving a powered vehicle (scooter, car, truck, ATV, motorcycle, tractor, etc.)
  • any concomitant injury to the affected limb
  • Bilateral distal radius fracture
  • Revision procedures
  • Worker's compensation status
  • Non-English speaking
  • No Internet Access
  • Inability to provide informed consent
  • Patients with known lymphovascular disorders, including peripheral arterial disease (PAD), prior deep vein thrombosis (DVT) or chronic lymphedema
  • Patients with known genetic or other hypercoagulability disorders including those on long-term anticoagulation or anti-platelet therapy (other than prophylactic aspirin)
  • Uncontrolled hypertension
  • Patients with dialysis catheters or AV fistula
  • Any other medical condition that affects the risk profile of the patient or that affects the normal physiologic function of the circulatory system of the extremities, based on sole discretion and medical judgement of the Primary Investigator

结局指标

主要结局

PROMIS Pain interference SF V1.1

时间窗: 3 months

PRWE

时间窗: 3 months

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

Peter J Apel

Orthopaedic surgeon

Carilion Clinic

研究点 (2)

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