跳至主要内容
临床试验/NCT05492396
NCT05492396进行中(未招募)不适用

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

Ohio State University3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
3
主要终点
Assess overall tissue quality by ultrasound assessment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Assess overall tissue quality by ultrasound assessment

时间窗: 6 month

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

Assess overall tissue thickness by ultrasound assessment

时间窗: 6 month

Unit measured in centimeters

Assess overall tissue organization by ultrasound assessment

时间窗: 6 month

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

次要结局

  • International Hip Outcome Tool questionnaire(Screening, 6 weeks, 3 month, 6 month, 12 months)
  • Modified Harris Hip Score questionnaire(Screening, 6 weeks, 3 month, 6 month, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Vasileff

Associate Professor

Ohio State University

研究点 (3)

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