ORIF Distal Radius Blood Flow Restriction Therapy (ORIF DR BFR)

Effects of Blood Flow Restriction Rehabilitation After ORIF of Distal Radius Fractures

Patients commonly experience a significant amount of muscular atrophy following open reduction internal fixation (ORIF) surgery of distal radius fractures, associated with an increased risk of re-injury, and an increase in time of recovery. A combination of low intensity resistance exercise and blood flow restriction (BFR) therapy has been shown to elicit responses similar to high intensity resistance exercise with reduced risk. We hypothesize that chronic low intensity resistance exercise combined with BFR will improve muscular strength, reduce skeletal muscle atrophy, and will enhance recovery.

Therefore, the specific aims of this study are as follows:

1. Determine if BFR added to standard post-operative rehab will prevent skeletal muscle atrophy and promote skeletal muscle growth during 12-weeks of rehab training compared to traditional rehab alone. The working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle growth and prevent atrophy to a greater extent than rehab alone.
2. Determine if BFR added to standard post-operative rehab will improve muscular strength following surgery compared to traditional rehab alone. Because strength can be attributed to skeletal muscle mass, the working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle strength and fatigue resistance to a greater extent than rehab alone.
3. Determine if BFR added to standard post-operative rehab will improve functional outcomes following surgery compared to traditional rehab alone. The working hypothesis, founded on previous literature is that BFR will improve functional outcomes over rehab alone.

Study Overview

• Status: Recruiting
• Conditions: Distal Radius Fractures
• Intervention / Treatment: Device: Blood Flow Restriction (BFR) Cuff

Detailed Description

he study will be a prospective randomized control trial consisting of subjects requiring ORIF of the distal radius. Subjects will be divided into two groups based on age, then subsequently be randomly divided into two groups following their inclusion in the study.

Groups will be normalized based on gender. One group will undergo the normal rehabilitation protocol for the hand and wrist as determined by Dr. Liberman. The study group will undergo rehabilitation protocol for distal radius fractures modified by use of a tourniquet for blood flow restriction during selected exercises. On the day of the procedure, the surgeon will measure the subject's forearm girth, the location of the largest circumference. The subject will then undergo the normal operative fixation of the distal radius fracture. A subject will be excluded from the study if they have had any prior surgeries on their affected wrist. At the subject's two week postoperative clinic visit, the physician will measure forearm girth. Study group subjects will begin physical therapy instructed BFR exercises at two weeks post operatively. Study group subjects will be taken through normal hand and wrist rehab protocol as well as BFR exercises. Control group subjects will do the same exercises and formal physical therapy rehab protocol as the study group without BFR.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haley Goble, MHA; Phone Number: 7134413930; Email: hmgoble@houstonmethodist.org
• Study Contact Backup: Name: Roxanne Miller; Phone Number: 3462381086; Email: rmiller2@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Contact: Haley Goble, MHA; Phone Number: 713-441-3930; Email: hmgoble@houstonmethodist.org
      • Contact: Roxanne Miller; Phone Number: 3462381086; Email: rmiller2@houstonmethodist.org
      • Principal Investigator: Shari Liberman, MD
      • Sub-Investigator: Kourosh Jafarnia, MD
      • Sub-Investigator: Patrick McCulloch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18+
• With acute fracture of distal radius requiring ORIF surgery

Exclusion Criteria:

• Exorbitant pain (VAS >8/10) related or unrelated to exercise
• Prior trauma or surgery to the observed limb
• Level 2 Obesity (BMI>35)
• Diabetes - Type II
• Cardiovascular, renal, liver or pulmonary disease
• Active infections
• Cancer (current or treated within the past 2 years)
• Bleeding or coagulation disorder
• Rapid weight change within the past year
• Physically unable to participate in the intervention
• Currently taking, or recently (w/in 1month of participation) taken prescribed or over the counter ergogenic aids or compounds known to be banned by the NCAA
• Unable to complete a minimum of 85% of the assigned rehabilitation sessions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care postoperative rehabilitation. Subject will undergo standard rehab following surgery without BFR.
Experimental: Intervention - Blood Flow Restriction Therapy (BFR); Subjects will undergo standard postoperative rehabilitation that incorporates BFR during certain exercises.	Device: Blood Flow Restriction (BFR) Cuff; The intervention group will receive therapy with a blood flow restriction cuff that restricts blood flow at their individual limb occlusion pressure during specific exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition / bone density	Soft tissue analysis of forearm and total body via DEXA scan.	DEXA scans will be recorded at the first rehabilitation visit (one week post-op), and then at two weeks, six weeks and 12 weeks following the initiation of rehabilitation.
Forearm girth	The location of the largest circumference will be measured by the operating surgeon. Values recorded in cm.	Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.
Grip strength	Grip strength will be measured for both left and right hands using a handheld dynamometer. Values recorded in lbs.	Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.
Pinch grip strength	Pinch grip strength will be measured for both left and right hands using a handheld dynamometer. Values recorded in lbs.	Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DASH survey	Patient reported outcome surveys will be completed by all participants to measure information relating to pain/symptoms and functional ability post-op.	This survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.
Michigan Hand Outcomes survey	Patient reported outcome surveys will be completed by all participants to measure information relating to pain/symptoms and functional ability post-op.	This survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.
Patient Rated Wrist Evaluation	Patient reported outcome surveys will be completed by all participants to measure information relating to pain/symptoms and functional ability post-op.	This survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Shari Liberman, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Radius Fractures; Wrist Fractures
• Other Study ID Numbers: Pro000022755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes