Closed Femur FractureREPAIRNCT02746458
Rehabilitation Enhanced by Partial Arterial Inflow Restrictions
A study testing Blood Flow Restriction and Delfi PTSII Tourniquet System in people with Closed Femur Fracture, run by Major Extremity Trauma Research Consortium at 8 sites in United States.
Trial summary
The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be conducted in a patient population of individuals recovering from a traumatic diaphyseal fracture of the femur. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Closed Femur Fracture
- What is being tested?
- Blood Flow Restriction and Delfi PTSII Tourniquet System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Apr 2016to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults ages 18-55 inclusive
- Admitted to one of the participating clinical centers for operative treatment of a closed diaphyseal femur fracture with one of the following OTA codes: 32A, 32B or 32C (treated with an IM Nail).
Who cannot join
- Open diaphyseal femur fracture (except low velocity gunshot wounds) or severe crushing injuries to study limb.
- Additional fracture, dislocations or soft tissue injuries to the study limb that would compromise the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation.
- Any fractures, dislocations or soft tissue injuries to the contralateral limb or pelvis that would compromise the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation.
- Any treatment of the study injury in either group that would preclude application of the tourniquet cuff (e.g. vascular reconstruction, wound, flap, or skin graft).
- Injuries to other body systems (or other medical conditions) that would preclude the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation (e.g. spinal cord deficit; severe traumatic brain injury).
- Use of blood flow restriction (BFR) at any time between treatment and the start of physical therapy for the study.
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- Non-ambulatory pre-injury.
- Morbidly obese (BMI > 40).
- History of Peripheral Artery Disease and/or Peripheral Vascular Disease (PAD/PVD).
- Current or history of venous thromboembolism.
- Impaired circulation or peripheral vascular compromise.
- Previous revascularization at the study injury site.
- Extremities with dialysis access.
- Current diagnosis of acidosis.
- Diagnosis of sickle cell anemia.
- Current infection of the study injury.
- Current tumor (malignant or benign) distal to study injury and future tourniquet placement.
- Current use of medications or supplements that are known to increase clotting risk.
- Diagnosis of severe hypertension (blood pressure of 180/110).
- Skin grafts in which all bleeding points must be readily distinguished.
- Secondary or delayed surgical procedures to study injury after immobilization.
- Vascular grafting to the study injury.
- History of lymphotomies.
- Current diagnosis of cancer.
- Unable to speak either English or Spanish.
- Severe problems with maintaining follow-up (e.g. patients who are prisoners, homeless at the time of injury, who are intellectually challenged without adequate family support, or have document psychiatric disorders).
- Unable to provide informed consent.
- Patient has not been cleared to start physical therapy at the time of consent.
- Patient is pregnant.
- Patient received BFR between date of injury and start of Physical Therapy.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Carolinas Medical Center
Charlotte, North Carolina, 28204
MetroHealth
Cleveland, Ohio, 44109
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Methodist Hospital
Indianapolis, Indiana, 46202
San Antonio Military Medical Center
San Antonio, Texas, 78219
Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: REPAIR: Rehabilitation Enhanced by Partial Arterial Inflow Restrictions
The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be conducted in a patient population of individuals recovering from a traumatic diaphyseal fracture of the femur. Although the intervention can be used for any patient with muscle weakness following trauma, the persistent thigh weakness that follows a femur fracture provides a perfect model for evaluating the effectiveness of the REPAIR protocol.
- Conditions
- Closed Femur Fracture
- Being tested
- Blood Flow Restriction, Delfi PTSII Tourniquet System
- Keywords
- Blood Flow Restriction, Muscle Weakness, Physical therapy techniques, closed femoral fracture injuries
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionOther
Brief and intermittent blood flow restriction via a Delfi PTSII Tourniquet System will be used during physical therapy.
Delfi PTSII Tourniquet SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Physical Therapy | No intervention | This group will receive the standard of care physical therapy program for 6 weeks. |
| Blood Flow Restriction Plus Standard of Care Physical Therapy | Experimental | This group will receive the same standard of care physical therapy program for 6 weeks plus blood flow restriction. Receives: Other: Blood Flow Restriction; Device: Delfi PTSII Tourniquet System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip and Knee Strength measured using a stabilized hand held dynamometer
Five muscle actions were tested using a handheld dynamometer with the patient in the seated (knee extension, hip flexion), supine (hip abduction), and prone (knee flexion, hip extension) position.
Measured: up to 6 months
Muscle Volume assessed using mid-thigh girth circumference measurement
Two measures of thigh circumference were taken using a flexible measuring tape to estimate muscle volume; one measure was taken at 6 centimeters and one measure taken at 16 centimeters from the superior pole of the patella.
Measured: up to 6 months
Hip and Knee Range of Motion
Four assessments of active joint range of motion (hip and knee flexion and extension) were conducted using a goniometer
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start1 Apr 2016
- Primary completion1 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Femur FractureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Reider, PhD, Study director, Major Extremity Trauma Research Consortium Coordinating CenterDaniel J Stinner, MD, Principal investigator, San Antonio Military Medical CenterEllen J MacKenzie, PhD, Principal investigator, Major Extremity Trauma Research Consortium Coordinating Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746458
- Sponsor's protocol ID
- W81XWH-15-2-0067
- Acronym
- REPAIR
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2016
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REPAIR: Rehabilitation Enhanced by Partial Arterial Inflow Restrictions
- ClinicalTrials.gov ID
- NCT02746458
- Acronym / sponsor ID
- REPAIR / W81XWH-15-2-0067
- Conditions
- Closed Femur Fracture
- Keywords
- Blood Flow Restriction, Muscle Weakness, Physical therapy techniques, closed femoral fracture injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 21 Apr 2016 (estimated)
- 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.
The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be conducted in a patient population of individuals recovering from a traumatic diaphyseal fracture of the femur. Although the intervention can be used for any patient with muscle weakness following trauma, the persistent thigh weakness that follows a femur fracture provides a perfect model for evaluating the effectiveness of the REPAIR protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Physical Therapy | No intervention | –This group will receive the standard of care physical therapy program for 6 weeks. |
| Blood Flow Restriction Plus Standard of Care Physical Therapy | Experimental | Other: Blood Flow Restriction, Device: Delfi PTSII Tourniquet SystemThis group will receive the same standard of care physical therapy program for 6 weeks plus blood flow restriction. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults ages 18-55 inclusive
- Admitted to one of the participating clinical centers for operative treatment of a closed diaphyseal femur fracture with one of the following OTA codes: 32A, 32B or 32C (treated with an IM Nail).
Key exclusion criteria (30 listed)
- Open diaphyseal femur fracture (except low velocity gunshot wounds) or severe crushing injuries to study limb.
- Additional fracture, dislocations or soft tissue injuries to the study limb that would compromise the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation.
- Any fractures, dislocations or soft tissue injuries to the contralateral limb or pelvis that would compromise the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation.
- Any treatment of the study injury in either group that would preclude application of the tourniquet cuff (e.g. vascular reconstruction, wound, flap, or skin graft).
- Injuries to other body systems (or other medical conditions) that would preclude the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation (e.g. spinal cord deficit; severe traumatic brain injury).
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 RestrictionBrief and intermittent blood flow restriction via a Delfi PTSII Tourniquet System will be used during physical therapy. | Other | Blood Flow Restriction Plus Standard of Care Physical Therapy |
| Delfi PTSII Tourniquet System | Device | Blood Flow Restriction Plus Standard of Care Physical Therapy |
Primary outcome
Hip and Knee Strength measured using a stabilized hand held dynamometer
Time frame: up to 6 months
Five muscle actions were tested using a handheld dynamometer with the patient in the seated (knee extension, hip flexion), supine (hip abduction), and prone (knee flexion, hip extension) position.
Muscle Volume assessed using mid-thigh girth circumference measurement
Time frame: up to 6 months
Two measures of thigh circumference were taken using a flexible measuring tape to estimate muscle volume; one measure was taken at 6 centimeters and one measure taken at 16 centimeters from the superior pole of the patella.
Hip and Knee Range of Motion
Time frame: up to 6 months
Four assessments of active joint range of motion (hip and knee flexion and extension) were conducted using a goniometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
Lisa Reider, PhD study director
Major Extremity Trauma Research Consortium Coordinating Center
Daniel J Stinner, MD principal investigator
San Antonio Military Medical Center
Ellen J MacKenzie, PhD principal investigator
Major Extremity Trauma Research Consortium Coordinating Center
8 sites 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 and Delfi PTSII Tourniquet System in people with Closed Femur Fracture, run by Major Extremity Trauma Research Consortium at 8 sites 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 30 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: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hip and Knee Strength measured using a stabilized hand held dynamometer (time frame: up to 6 months). The study lists 3 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 26 May 2026.