Blood Flow Restriction with Delfi Tourniquet System Cuff for Hip Fractures

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, AL
Hip Fractures+4 More
Blood Flow Restriction with Delfi Tourniquet System Cuff - Device
Eligibility
65+
All Sexes
Eligible conditions
Hip Fractures

Study Summary

This study is evaluating whether blood flow restriction therapy can help improve physical therapy for elderly patients recovering from hip fractures.

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Eligible Conditions

  • Hip Fractures
  • Atrophy
  • Fractures, Bone
  • Muscular Atrophy
  • Wasting;Muscle(S)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Blood Flow Restriction with Delfi Tourniquet System Cuff will improve 5 primary outcomes, 8 secondary outcomes, and 5 other outcomes in patients with Hip Fractures. Measurement will happen over the course of Post op 2 weeks.

Post op 2 weeks
12-Item Short Form Health Survey (SF-12) (Mental Health Component)
12-Item Short Form Health Survey (SF-12) (Physical Health Component)
Five-times sit to stand test
Functional testing performed
Modified 30-second sit-to-stand test
Number of patient-reported falls
Objective muscle strength measured by a handheld dynamometer
Pain medicine requirements during 2-week stay
Participant self-reported outcome for pain
Participant self-reported outcome: Perceived Exertion (Borg Rating of Perceived Exertion)
Participants thigh circumference measurement
Patient-Reported Outcomes Measurement Information System (PROMIS)
Post-operative complications: Blood Clots
Post-operative complications: Deep Infection
Post-operative complications: Mortality
Post-operative complications: Nerve Damage
Therapist-reported compliance and adverse event logs
Timed Up and Go Test (TUG)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Routine Post-operative Physical Therapy
Routine Physical Therapy + Blood Flow Restriction and Neuromuscular Electrical Stimulation (NMES)

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Blood Flow Restriction With Delfi Tourniquet System Cuff is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Routine Physical Therapy + Blood Flow Restriction and Neuromuscular Electrical Stimulation (NMES)
Device
The intervention group will start with a Delfi tourniquet system cuff set on a limb occlusion pressure (LOP) of 60-100%. The intervention group will also use a neuromuscular electrical stimulation device at therapeutic level in addition to BFR.
Routine Post-operative Physical Therapy
Other
The control group will undergo routine post-op and undergo a modified version of the graduated therapy protocol.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post op 2 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly post op 2 weeks for reporting.

Who is running the study

Principal Investigator
C. S.
Clay Spitler, Principle Investigator
University of Alabama at Birmingham

Closest Location

University of Alabama at Birmingham - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient has a fracture of their proximal femur that has not been surgically treated or had orthopedic implants placed in the area show original
The patient is able to weight bear as tolerated after surgery, as deemed by the treating orthopedic surgeon. show original
Fractures that occur in the femur are excluded if they are due to a segmental or pathologic condition. show original
The person was able to walk around without any assistance before they got injured. show original
-care The person is alert and able to answer questions about their surroundings and what is happening show original
English speaking
People aged 65 years or older, of any gender or ethnicity. show original
OTA codes 31A, 31B, and 31C
was more beneficial to mental health than living alone after injury show original
No recent lower extremity injury or surgery on the opposite (contralateral) side. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common side effects of blood flow restriction with delfi tourniquet system cuff?

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One of the common side effects of blood flow restriction with delfi tourniquet system cuff was pain-associated with application of high level of pressure on the tourniquet cuff. We believe that further studies are needed before recommending its applications to a wide group of patients.

Unverified Answer

Can hip fractures be cured?

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Patients sustaining a hip fracture are at high risk of dying, even after controlling for confounding factors. The risk of death at 1 year doubles the risk of death at 2 years. The risk of death after 2 years differs by age and by fracture location.

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What is hip fractures?

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It was shown, that in Sweden as well as in other developed countries hip fractures are frequent. Hip fractures are classified as intrafemoral and extrafemoral. In Sweden, they occur in over 80% of male, and about 70% of female patients. Although they occur more often in elderly people, hip fractures also occur in middle-aged population. The occurrence of intrafemoral fractures increases with age, especially in geriatric females. In both sexes, type and place of occurrence and cause of the fractures vary greatly with age group and type of fracture.

Unverified Answer

How many people get hip fractures a year in the United States?

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These data suggest that hip fracture is prevalent in older Americans. Hip fracture accounts for 8 percent of all medical incidents and 16 percent of all hospital stays in the US.

Unverified Answer

What are the signs of hip fractures?

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Fracture line may be visible on x-rays of the pelvis. If a patient develops complications, such as persistent pain, it is important to suspect hip fracture.

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What causes hip fractures?

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In a recent study, findings proposes that occupational physical activity is a major causal factor for hip fracture among older adults in the community. Therefore, exercise should be strongly promoted among people aged 60 years and over.

Unverified Answer

What are common treatments for hip fractures?

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Many patients are treated following a diagnosis of hip fracture through a wide variety of methods. Fracture fixation is commonly performed, and immobilization is common following fixation. However, most treatments are palliative treatments in that they are not aimed at minimizing the extent of a patient's disability, but rather are meant to manage complications related to fractures. These include pressure sores, and respiratory complications such as pneumonia and a decreased level of oxygen. In most cases, surgical intervention is not necessary.

Unverified Answer

How does blood flow restriction with delfi tourniquet system cuff work?

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A brief period of blood flow restriction with the DFB cuff system induces a redistribution of blood volume to muscle capillaries, and may reduce postoperative edema formation.

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What is the latest research for hip fractures?

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We have found only one clinical trial to investigate hip fractures in the past 10 years, and it has not been well equipped or funded to examine this important issue (NCT00547782, ClinicalTrials.gov). Patients are the best ambassadors for research topics, so we have initiated a short-term collaborative clinical trial to evaluate the effects of [combination medication management for hip fractures in older adults with diabetes mellitus, osteoporosis, dementia, frailty, and chronic kidney disease (COMPARATE), which is funded by the UK NHS Clinical Trials Register (UKCTR)-CTR25331638 (http://www.nhs.

Unverified Answer

What is blood flow restriction with delfi tourniquet system cuff?

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There is adequate collateral blood flow to the ischemic limb, which is sufficient to keep the limb perfused, without causing ischemic complications. There are no signs of tissue damage and blood flow is improved from three to five minutes after application of the cuff.

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What is the average age someone gets hip fractures?

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About 45% of hip fracture patients suffer a hip fracture in their fifth decade of life. It is important to educate these patients about what to do after a hip fracture to prevent further complications.

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Have there been any new discoveries for treating hip fractures?

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Currently, no new treatments are approved for hip fractures for the treatment of post-fracture pain. However, we have been continually evaluating and improving our treatment algorithms based on advancements in fracture management. In order to provide more effective care to patients with hip fractures, we propose an improvement in fracture healing to prevent the development of post-fracture pain as well as prevention of complications.

Unverified Answer
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