ORIF Distal Radius Blood Flow Restriction Therapy

NCT06136286 | Active Not Recruiting DMC FDA Device

• 1 other identifier: Pro000022755
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

Distal Radius Fractures

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• DASH survey

  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

  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

  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.

Study Arms (2)

Control

NO INTERVENTION

Standard of care postoperative rehabilitation. Subject will undergo standard rehab following surgery without BFR.

Intervention - Blood Flow Restriction Therapy (BFR)

EXPERIMENTAL

Subjects will undergo standard postoperative rehabilitation that incorporates BFR during certain exercises.

Device: Blood Flow Restriction (BFR) Cuff

Interventions

Blood Flow Restriction (BFR) Cuff DEVICE

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.

Intervention - Blood Flow Restriction Therapy (BFR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Shari Liberman, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The 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. Group 1) Control group in which subjects receive standard of care rehab. Group 2) BFR group in which BFR is incorporated into the patients' rehab. 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.

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 18, 2023
• Study Start: October 22, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)