Evaluation of Healing Following Open Gluteus Medius Repair With Biointegrative Implant

NCT05492396 | Active Not Recruiting FDA Device

• 1 other identifier: 2021H0451
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Tendon Injuries; Hip Injuries; Orthopedic Procedures

Outcome Measures

Primary Outcomes (3)

• Assess overall tissue quality by ultrasound assessment

  Graded as 'Intact/Attenuated/Disrupted'. Intact being the positive outcome, disrupted being the negative outcome.

  6 month

• Assess overall tissue thickness by ultrasound assessment

  Unit measured in centimeters

  6 month

• Assess overall tissue organization by ultrasound assessment

  Hypoechoic signal present or absent. Present being the positive outcome, absent being the negative outcome

  6 month

Secondary Outcomes (2)

• Modified Harris Hip Score questionnaire

  Screening, 6 weeks, 3 month, 6 month, 12 months

• International Hip Outcome Tool questionnaire

  Screening, 6 weeks, 3 month, 6 month, 12 months

Study Arms (1)

Standard gluteus medius repair

Subjects will all undergo standard gluteus medius repair that includes augmentation with the biointegrative implant.

Device: Standard gluteus medius repair with Tapestry Biointegrative implant

Interventions

Standard gluteus medius repair with Tapestry Biointegrative implant DEVICE

Patients will undergo standard gluteus medius repair utilizing augmentation.

Standard gluteus medius repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a gluteal tendon tear where surgical repair is indicated will be screened for inclusion. Those that meet all inclusion criteria and no exclusion criteria will be invited to participate

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (3)

Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202, United States

Location

The Ohio State University Hospital East

Columbus, Ohio, 43203, United States

Location

Ohio State Outpatient Care New Albany

Westerville, Ohio, 43081, United States

Location

MeSH Terms

Conditions

Hip Injuries; Tendon Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• William K Vasileff, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 8, 2022
• Study Start: August 1, 2022
• Primary Completion: June 25, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)