Evaluation of Healing Following Open Gluteus Medius Repair With Biointegrative Implant
Sponsored by Ohio State University
About this trial
Last updated 2 years ago
Study ID
2021H0451
Status
Recruiting
Type
Observational
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended a year ago
What is this trial about?
This is a prospective, single-center study design with enrollment of 15 subjects. The 15
subjects will all undergo standard gluteus medius repair that includes augmentation with the
biointegrative implant. This is a small observational study. As such, we expect that the
results from 15 subjects will give an adequate understanding of post surgical healing.
What are the participation requirements?
Inclusion Criteria
1. Patients at least 18 years of age
2. Patients healthy enough to undergo procedure
3. Large partial tear and full thickness gluteal tendon tear requiring augmentation
4. Willing and able to make all required visits
5. Able to read and write in English
Exclusion Criteria
1. Hypersensitivity or objection to using bovine derived materials
2. Significant atrophy or major retraction of gluteal tendon
3. Women who are pregnant or nursing
4. History of poor compliance with medical treatment
5. Patients who are incarcerated
Locations
Location
Status
Recruiting
Recruiting
Recruiting