Active — Not RecruitingNot Applicable

Evaluation of Healing Following Open Gluteus Medius Repair With Biointegrative Implant

United States30 participantsStarted 2022-08-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients at least 18 years of age
✓. Patients healthy enough to undergo procedure
✓. Large partial tear and full thickness gluteal tendon tear requiring augmentation
✓. Willing and able to make all required visits
✓. Able to read and write in English

Exclusion criteria

✕. Hypersensitivity or objection to using bovine derived materials
✕. Significant atrophy or major retraction of gluteal tendon
✕. Women who are pregnant or nursing
✕. History of poor compliance with medical treatment
✕. Patients who are incarcerated

What they're measuring

Assess overall tissue quality by ultrasound assessment

Timeframe: 6 month

Assess overall tissue thickness by ultrasound assessment

Timeframe: 6 month

Assess overall tissue organization by ultrasound assessment

Timeframe: 6 month

Trial details

NCT IDNCT05492396

SponsorOhio State University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-25

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