Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2020-10-20
2023-12-31
Brief Summary
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Detailed Description
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Rehabilitative exercises would be advanced per the physical therapists' discretion with similar exercises for patients in both groups for direct comparison. These exercises are part of an already-established post-operative protocol that is in place, with the only difference being the addition of the blood flow restriction protocol in the intervention group. All patients would undergo their supervised post-operative rehabilitation at our institution.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Blood flow restriction
The blood flow restriction arm will include the use of the pneumatic tourniquet applied to the operative lower extremity throughout post-operative rehabilitation sessions. The tourniquet pressure will be titrated to 80% of the measured extremity arterial limb occlusion pressure with the participant lying supine.
Blood flow restriction (Delfi Personalized Tourniquet System)
The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.
Standard rehabilitation
Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.
Standard rehabilitation
The standard rehabilitation arm will undergo the same rehabilitation protocol as the experimental arm. A tourniquet will still be applied, but will only be inflated to 20 mmHg, a pressure that will not occlude blood flow.
Standard rehabilitation
Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.
Interventions
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Blood flow restriction (Delfi Personalized Tourniquet System)
The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.
Standard rehabilitation
Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with Diabetes Mellitus, vascular disease, or infections of the involved extremity
18 Years
60 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Sachin Allahabadi, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-29641
Identifier Type: -
Identifier Source: org_study_id
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