A Study to Evaluate Low-Intensity Blood Flow Restriction Training to Improve Post-Operative Outcomes for ACL Reconstruction
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-008473
NCT ID: NCT04302558
Sponsor Protocol Number: 19-008473
About this study
The purpose of this study is to analyze the difference between the Blood Flow Restriction (BFR) and SHAM-BFR groups in change in muscle diameter (hypertrophy) from 2 weeks pre-operative to 8-10 days post-operative.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subjects must be between 13 and 40 years old.
- Subjects must have been previously diagnosed with a tear of the anterior cruciate ligament in one of the lower extremities that requires surgical reconstruction.
- Subjects must be able to understand study procedures and comply with them for the entire duration of the study.
- Subjects must have normal contralateral limb strength.
Exclusion Criteria:
- Subjects with any personal history of deep vein thrombosis or with such history in their immediate family.
- Subjects who have any multi-ligamentous injuries to the knee that require modified post-operative unloading.
- Subjects who have history of previous anterior cruciate ligament reconstructions in either the affected or unaffected leg.
- Subjects with an inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Anikar Chhabra, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available