Distal Radius FracturesORIF DR BFRNCT06136286
ORIF Distal Radius Blood Flow Restriction Therapy
A study testing Blood Flow Restriction (BFR) Cuff in people with Distal Radius Fractures, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Blood Flow Restriction (BFR) Cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2019to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18+
- With acute fracture of distal radius requiring ORIF surgery
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
- 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.
- 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.
Read the 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.
- Conditions
- Distal Radius Fractures
- Being tested
- Blood Flow Restriction (BFR) Cuff
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction (BFR) CuffDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Blood Flow Restriction (BFR) Cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition / bone density
Soft tissue analysis of forearm and total body via DEXA scan.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.
Secondary outcomes (3)
DASH survey
Patient reported outcome surveys will be completed by all participants to measure information relating to pain/symptoms and functional ability post-op.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start22 Oct 2019
- Primary completion31 Dec 2025
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shari Liberman, The Methodist Hospital Research Institute
- Investigators
- Shari Liberman, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136286
- Sponsor's protocol ID
- Pro000022755
- Acronym
- ORIF DR BFR
- Status last verified
- Mar 2026
- First submitted
- 1 Nov 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Rehabilitation After ORIF of Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT06136286
- Acronym / sponsor ID
- ORIF DR BFR / Pro000022755
- Conditions
- Distal Radius Fractures
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care postoperative rehabilitation. Subject will undergo standard rehab following surgery without BFR. |
| Intervention - Blood Flow Restriction Therapy (BFR) | Experimental | Device: Blood Flow Restriction (BFR) CuffSubjects will undergo standard postoperative rehabilitation that incorporates BFR during certain exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18+
- With acute fracture of distal radius requiring ORIF surgery
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction (BFR) CuffThe intervention group will receive therapy with a blood flow restriction cuff that restricts blood flow at their individual limb occlusion pressure during specific exercises. | Device | Intervention - Blood Flow Restriction Therapy (BFR) |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
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.
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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari Liberman, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction (BFR) Cuff in people with Distal Radius Fractures, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.