Hip InjuriesNCT05492396
Evaluation of Healing Following Open Gluteus Medius Repair With Biointegrative Implant
An observational study of Hip Injuries and Tendon Injuries, run by Ohio State University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Injuries, Tendon Injuries, Orthopedic Procedures
- What is being tested?
- Standard gluteus medius repair with Tapestry Biointegrative implant
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2022to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Jameson Crane Sports Medicine Institute
Columbus, Ohio, 43202
The Ohio State University Hospital East
Columbus, Ohio, 43203
Ohio State Outpatient Care New Albany
Westerville, Ohio, 43081
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Injuries, Tendon Injuries, Orthopedic Procedures
- Being tested
- Standard gluteus medius repair with Tapestry Biointegrative implant
- Medical subject headings
- Hip Injuries, Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard gluteus medius repair with Tapestry Biointegrative implantDevice
Patients will undergo standard gluteus medius repair utilizing augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Standard gluteus medius repair | Subjects will all undergo standard gluteus medius repair that includes augmentation with the biointegrative implant. Receives: Device: Standard gluteus medius repair with Tapestry Biointegrative implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess overall tissue quality by ultrasound assessment
Graded as 'Intact/Attenuated/Disrupted'. Intact being the positive outcome, disrupted being the negative outcome.
Measured: 6 month
Assess overall tissue thickness by ultrasound assessment
Unit measured in centimeters
Measured: 6 month
Assess overall tissue organization by ultrasound assessment
Hypoechoic signal present or absent. Present being the positive outcome, absent being the negative outcome
Measured: 6 month
Secondary outcomes (2)
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
Measured: 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.
Measured: Screening, 6 weeks, 3 month, 6 month, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Aug 2022
- Primary completion25 Jun 2025
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Vasileff, Ohio State University
- Investigators
- William K Vasileff, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492396
- Sponsor's protocol ID
- 2021H0451
- Status last verified
- Mar 2026
- First submitted
- 2 Aug 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Healing Following Open Gluteus Medius Repair Augmented With a Biointegrative Implant
- ClinicalTrials.gov ID
- NCT05492396
- Acronym / sponsor ID
- 2021H0451
- Conditions
- Hip Injuries, Tendon Injuries, Orthopedic Procedures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard gluteus medius repair | – | Device: Standard gluteus medius repair with Tapestry Biointegrative implantSubjects will all undergo standard gluteus medius repair that includes augmentation with the biointegrative implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard gluteus medius repair with Tapestry Biointegrative implantPatients will undergo standard gluteus medius repair utilizing augmentation. | Device | Standard gluteus medius repair |
Primary outcome
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.
Assess overall tissue thickness by ultrasound assessment
Time frame: 6 month
Unit measured in centimeters
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
2 secondary outcomes
Modified Harris Hip Score questionnaire
Time frame: Screening, 6 weeks, 3 month, 6 month, 12 months
International Hip Outcome Tool questionnaire
Time frame: Screening, 6 weeks, 3 month, 6 month, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William K Vasileff, MD principal investigator
Ohio State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Injuries and Tendon Injuries, run by Ohio State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess overall tissue quality by ultrasound assessment (time frame: 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.