Can a tourniquet help you recover from a broken leg faster?
NCT ID NCT02746458
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether briefly restricting blood flow to the leg during physical therapy could help people regain strength and muscle after a broken femur (thigh bone). 219 adults aged 18-55 with a closed femur fracture took part. The approach uses a special tourniquet system during exercise to potentially boost recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Blood flow restriction device (Delfi PTSII Tourniquet System)
- What this could lead to
- If it works, this could offer a simple, non-drug way to speed up muscle recovery after a broken leg.
- What could go wrong
- This is a completed study, but the approach is still experimental and may not work for everyone. The device is used only during therapy sessions and results may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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219 people
The number who actually took part.
- Started
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Apr 2016
- Finished
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Sep 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adults ages 18-55 inclusive 2. 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). Exclusion Criteria: 1. Open diaphyseal femur fracture (except low velocity gunshot wounds) or severe crushing injuries to study limb. 2. 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. 3. 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. 4. 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). 5. 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). 6. Use of blood flow restriction (BFR) at any time between treatment and the start of physical therapy for the study. 7. Non-ambulatory pre-injury. 8. Morbidly obese (BMI \> 40). 9. History of Peripheral Artery Disease and/or Peripheral Vascular Disease (PAD/PVD). 10. Current or history of venous thromboembolism. 11. Impaired circulation or peripheral vascular compromise. 12. Previous revascularization at the study injury site. 13. Extremities with dialysis access. 14. Current diagnosis of acidosis. 15. Diagnosis of sickle cell anemia. 16. Current infection of the study injury. 17. Current tumor (malignant or benign) distal to study injury and future tourniquet placement. 18. Current use of medications or supplements that are known to increase clotting risk. 19. Diagnosis of severe hypertension (blood pressure of 180/110). 20. Skin grafts in which all bleeding points must be readily distinguished. 21. Secondary or delayed surgical procedures to study injury after immobilization. 22. Vascular grafting to the study injury. 23. History of lymphotomies. 24. Current diagnosis of cancer. 25. Unable to speak either English or Spanish. 26. 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). 27. Unable to provide informed consent. 28. Patient has not been cleared to start physical therapy at the time of consent. 29. Patient is pregnant. 30. Patient received BFR between date of injury and start of Physical Therapy.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
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Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
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Methodist Hospital
Indianapolis, Indiana, 46202, United States
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MetroHealth
Cleveland, Ohio, 44109, United States
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San Antonio Military Medical Center
San Antonio, Texas, 78219, United States
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University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
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University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
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Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States