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BFR Therapy Following DRF

Primary Purpose

Distal Radius Fracture

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Blood Flow Restriction

Standard of Care Physical Therapy

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Blood Flow Restriction

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Carilion ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Blood Flow Restriction Supplemented

Arm Description

Outcomes

Primary Outcome Measures

PROMIS Pain interference SF V1.1

PRWE

Secondary Outcome Measures

Full Information

NCT ID

NCT05396521

First Posted

May 25, 2022

Last Updated

May 25, 2022

Sponsor

Carilion Clinic

Collaborators

Virginia Polytechnic Institute and State University

1. Study Identification

Unique Protocol Identification Number

NCT05396521

Brief Title

BFR Therapy Following DRF

Official Title

Utilizing Blood Flow Restriction Therapy Following ORIF Treated Distal Radius Fractures

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 26, 2022 (Actual)

Primary Completion Date

May 26, 2024 (Anticipated)

Study Completion Date

April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Carilion Clinic

Collaborators

Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Distal Radius Fracture

Keywords

Blood Flow Restriction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Title

Blood Flow Restriction Supplemented

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Blood Flow Restriction

Intervention Description

Group 2 (experimental) will receive standard of care physical therapy to be done with blood flow restriction therapy (BFR). This method includes standard of care physical therapy while occluding blood flow.

Intervention Type

Other

Intervention Name(s)

Standard of Care Physical Therapy

Intervention Description

Group 1 (Control) will receive standard of care physical therapy.

Primary Outcome Measure Information:

Title

PROMIS Pain interference SF V1.1

Time Frame

3 months

Title

PRWE

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Evan P Sandefur

Phone

262-893-2786

evansandefur@vt.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Peter J Apel, MD, PhD

pjapel@carilionclinic.org

Facility Information:

Facility Name

Carilion Clinic

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Darren T Hackley

Phone

540-613-2972

dthackley@carilionclinic.org

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30725601

Citation

Corsino CB, Reeves RA, Sieg RN. Distal Radius Fractures. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536916/

Results Reference

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PubMed Identifier

29169594

Citation

Pope D, Tang P. Carpal Tunnel Syndrome and Distal Radius Fractures. Hand Clin. 2018 Feb;34(1):27-32. doi: 10.1016/j.hcl.2017.09.003.

Results Reference

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PubMed Identifier

33892883

Citation

Kooner P, Grewal R. Is Therapy Needed After Distal Radius Fracture Treatment, What Is the Evidence? Hand Clin. 2021 May;37(2):309-314. doi: 10.1016/j.hcl.2021.02.012.

Results Reference

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PubMed Identifier

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Citation

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Citation

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PubMed Identifier

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Citation

Gundermann DM, Walker DK, Reidy PT, Borack MS, Dickinson JM, Volpi E, Rasmussen BB. Activation of mTORC1 signaling and protein synthesis in human muscle following blood flow restriction exercise is inhibited by rapamycin. Am J Physiol Endocrinol Metab. 2014 May 15;306(10):E1198-204. doi: 10.1152/ajpendo.00600.2013. Epub 2014 Apr 1.

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PubMed Identifier

21840132

Citation

Loenneke JP, Fahs CA, Wilson JM, Bemben MG. Blood flow restriction: the metabolite/volume threshold theory. Med Hypotheses. 2011 Nov;77(5):748-52. doi: 10.1016/j.mehy.2011.07.029. Epub 2011 Aug 12.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

Shakeel R, Khan AA, Ayyub A, Masood Z. Impact of strengthening exercises with and without blood flow restriction on quadriceps of knee osteoarthritis patients. J Pak Med Assoc. 2021 Sep;71(9):2173-2176. doi: 10.47391/JPMA.377.

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Citation

Cheema AS, O'Brien PJ, Broekhuyse HM, Lefaivre KA. Measuring Outcomes Over Time in Distal Radius Fractures: A Comparison of Generic, Upper Extremity-Specific and Wrist-Specific Outcome Measures. J Hand Surg Glob Online. 2020 Aug 14;2(5):272-276. doi: 10.1016/j.jhsg.2020.06.006. eCollection 2020 Sep.

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Citation

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Results Reference

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BFR Therapy Following DRF

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