Evaluation of Healing Following Open Gluteus Medius Repair With Biointegrative Implant

Hip Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492396
• Other study ID #: 2021H0451
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: Michael Keller
• Phone: (614) 293-2410
• Email: michael.keller[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. As such, we expect that the results from 15 subjects will give an adequate understanding of post surgical healing.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Injuries
• Orthopedic Procedures
• Tendon Injuries
• Wounds and Injuries

Intervention

Device:
• Standard gluteus medius repair with Tapestry Biointegrative implant
Patients will undergo standard gluteus medius repair utilizing augmentation.

Locations

Country	Name	City	State
United States	Jameson Crane Sports Medicine Institute	Columbus	Ohio
United States	The Ohio State University Hospital East	Columbus	Ohio
United States	Ohio State Outpatient Care New Albany	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess overall tissue quality by ultrasound assessment	Graded as 'Intact/Attenuated/Disrupted'. Intact being the positive outcome, disrupted being the negative outcome.	6 month
Primary	Assess overall tissue thickness by ultrasound assessment	Unit measured in centimeters	6 month
Primary	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	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
Secondary	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