Evaluation of Healing Following Open Gluteus Medius Repair With Biointegrative Implant

Evaluation of Healing Following Open Gluteus Medius Repair Augmented With a Biointegrative Implant

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tendon Injuries; Hip Injuries; Orthopedic Procedures
• Intervention / Treatment: Device: Standard gluteus medius repair with Tapestry Biointegrative implant

Detailed Description

Surgical gluteal tendon repair is a procedure performed regularly in operating rooms everywhere. This procedure is normally recommended to address gluteal tendon tears after nonoperative treatment options have been exhausted. However, less than satisfactory long-term outcomes can be common after open gluteal tendon repair. The augmentation of tendon repairs via various biointegrative implants is becoming more common in clinical practice, however very little, if any, of the literature details the healing after surgical intervention.

Biointegrative implants have been studied for the use of augmenting other tendon repairs, such as rotator cuff tears. Successful complete rotator cuff repairs augmented with a collagen-based implant have indicated that biointegrative implants are a safe option that may provide greater rates of healing and more positive long-term outcomes (Thon SG, 2019). Rates of healing and long-term outcomes when using a patch of this sort in other tendons such as the gluteal tendon in the hip show promise and demonstrate that there is a need for this area of study.

A 2016 study evaluated augmenting gluteus medius repair with a bioinductive implant, but the surgery was performed using endoscopic technique. There is no literature studying the healing of collagen-based implants for open gluteal tendon repairs. Although clinical outcomes show similar level of improvement for endoscopic and open gluteal tendon tear repair (Maslaris A, 2020), open repair technique with more anchors may be required for larger or more intricate tears.

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43202
      • Jameson Crane Sports Medicine Institute
    • Columbus, Ohio, United States, 43203
      • The Ohio State University Hospital East
    • Westerville, Ohio, United States, 43081
      • Ohio State Outpatient Care New Albany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patients will undergo standard gluteus medius repair utilizing augmentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Harris Hip Score questionnaire	Measures the functional status of the hip. Scores range from 0-100 where 100 means best functional outcome and least pain	Screening, 6 weeks, 3 month, 6 month, 12 months
International Hip Outcome Tool questionnaire	Assesses deficiencies with respect to outcome assessment of patients with hip disorders. Scores range from 0-100. Higher scores represent better quality of life.	Screening, 6 weeks, 3 month, 6 month, 12 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: William K Vasileff, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): June 25, 2025
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries; Hip Injuries
• Other Study ID Numbers: 2021H0451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No