Clinical trial NCT05492396: Evaluation of Healing Following Open Gluteus Medius Repair With Biointegrative Implant
Official title: Evaluation of Healing Following Open Gluteus Medius Repair Augmented With a Biointegrative Implant
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hip Injuries
Tendon Injuries
Orthopedic Procedures
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess overall tissue quality by ultrasound assessment
timeFrame: 6 month
measure: Assess overall tissue thickness by ultrasound assessment
timeFrame: 6 month
measure: Assess overall tissue organization by ultrasound assessment
timeFrame: 6 month
Secondary outcomes:
measure: Modified Harris Hip Score questionnaire
timeFrame: Screening, 6 weeks, 3 month, 6 month, 12 months
measure: International Hip Outcome Tool questionnaire
timeFrame: Screening, 6 weeks, 3 month, 6 month, 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Jameson Crane Sports Medicine Institute
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Hospital East
state: Ohio
city: Westerville
country: United States
facility: Ohio State Outpatient Care New Albany
state: Ohio
Study officials:
affiliation: Ohio State University
name: William K Vasileff, MD
role: PRINCIPAL_INVESTIGATOR
References: