Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05492396
Other study ID # 2021H0451
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Withdrawn NCT04720274 - Utilizing EMG Shorts in Hip Population N/A
Not yet recruiting NCT05484778 - Analysis of Balance and Functional Hop Tests Used for Return to Sports in Athletes With Lower Extremity Injuries by Dual Task Study N/A
Withdrawn NCT05030688 - Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty N/A
Completed NCT04070430 - Crutch Use After Arthroscopic Hip Surgery N/A
Completed NCT03172923 - Nail Versus Sliding Hip Screw for Trochanteric Hip Fractures N/A
Active, not recruiting NCT04925791 - Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy N/A
Completed NCT06087549 - PENG Block vs. ESP Block for Pediatric Hip Surgery Phase 4
Recruiting NCT05038709 - Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness N/A
Recruiting NCT04934462 - Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability N/A
Recruiting NCT05397145 - Iliopsoas Plane Block vs PENG Block for Hip Arthroplasty N/A
Recruiting NCT06212622 - Is the Rate of Early Mobilisation in Hip Fracture Patients Using Alfentanil Better Than Standard Opioid Analgesia?
Not yet recruiting NCT05762588 - JuggerKnot With Broadband PMCF Study
Completed NCT05245097 - Mitigation of Major Hip Injury Due to Fall With a Smart Belt N/A
Recruiting NCT06064136 - Psoas Tenotomy Under Ultrasound N/A
Completed NCT02990234 - Capsular Repair in FAI Impingement Surgery N/A
Completed NCT02630160 - The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement Phase 4
Recruiting NCT06332443 - Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty. N/A
Completed NCT05343195 - Balance and Leg Function After Hip Replacement N/A
Completed NCT04210440 - The Treatment of Initial Stage of Hip Osteonecrosis: the Core Decompression N/A
Completed NCT01833481 - THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches