Evaluation of Healing Following Open Gluteus Medius Repair With Biointegrative Implant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hip Injuries Tendon Injuries Orthopedic Procedures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard gluteus medius repair

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

Standard gluteus medius repair with Tapestry Biointegrative implant

Intervention Type DEVICE

Patients will undergo standard gluteus medius repair utilizing augmentation.

Interventions

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Standard gluteus medius repair with Tapestry Biointegrative implant

Patients will undergo standard gluteus medius repair utilizing augmentation.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No