Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06136286

ORIF Distal Radius Blood Flow Restriction Therapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Distal Radius Fractures Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Body composition / bone density

    Time frame: 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.

    Soft tissue analysis of forearm and total body via DEXA scan.

  2. Forearm girth

    Time frame: Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.

    The location of the largest circumference will be measured by the operating surgeon. Values recorded in cm.

  3. Grip strength

    Time frame: Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.

    Grip strength will be measured for both left and right hands using a handheld dynamometer. Values recorded in lbs.

  4. Pinch grip strength

    Time frame: Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.

    Pinch grip strength will be measured for both left and right hands using a handheld dynamometer. Values recorded in lbs.

Secondary outcomes

  1. DASH survey

    Time frame: 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 reported outcome surveys will be completed by all participants to measure information relating to pain/symptoms and functional ability post-op.

  2. Michigan Hand Outcomes survey

    Time frame: 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 reported outcome surveys will be completed by all participants to measure information relating to pain/symptoms and functional ability post-op.

  3. Patient Rated Wrist Evaluation

    Time frame: 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 reported outcome surveys will be completed by all participants to measure information relating to pain/symptoms and functional ability post-op.

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

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

Acronym: ORIF DR BFR

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.