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NCT Number: NCT05492396

Evaluation of Healing Following Open Gluteus Medius Repair With 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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jameson Crane Sports Medicine Institute, Columbus, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard gluteus medius repair with Tapestry Biointegrative implant

Device

Patients will undergo standard gluteus medius repair utilizing augmentation.

Primary outcomes

  1. Assess overall tissue quality by ultrasound assessment

    Time frame: 6 month

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

  2. Assess overall tissue thickness by ultrasound assessment

    Time frame: 6 month

    Unit measured in centimeters

  3. Assess overall tissue organization by ultrasound assessment

    Time frame: 6 month

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

Secondary outcomes

  1. Modified Harris Hip Score questionnaire

    Time frame: Screening, 6 weeks, 3 month, 6 month, 12 months

    Measures the functional status of the hip. Scores range from 0-100 where 100 means best functional outcome and least pain

  2. International Hip Outcome Tool questionnaire

    Time frame: Screening, 6 weeks, 3 month, 6 month, 12 months

    Assesses deficiencies with respect to outcome assessment of patients with hip disorders. Scores range from 0-100. Higher scores represent better quality of life.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Aug 8, 2022
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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