A Multi-Center, Prospective Post-Market Clinical Follow-Up Study: Subscapularis Repair Augmented With Tapestry Biointegrative Implant After Shoulder Arthroplasty Evaluation (RAISE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Subscapularis repair integrity
研究概览
简要总结
A multi-center, prospective post-market clinical follow-up study: subscapularis repair augmented with Tapestry Biointegrative Implant after shoulder arthroplasty. The primary objective of this study is to evaluate the long-term integrity of the subscapularis tendon repair after shoulder arthroplasty augmented with Tapestry Biointegrative Implant, assessed by ultrasound 6 months postoperatively. Secondary objectives are to assess shoulder function (internal rotation strength), safety, and patient reported outcomes. Patients will be evaluated preoperatively, at the time of surgery, 3, 6, 12 and 24 months after surgery.
详细描述
The proposed investigation is a multi-center, prospective patient registry: subscapularis repair augmented with TAPESTRY® Biointegrative Implant after shoulder arthroplasty. The primary objective of this study is to evaluate the long-term integrity of the subscapularis tendon repair after shoulder arthroplasty augmented with TAPESTRY Biointegrative Implant, assessed by ultrasound 6 months postoperatively. Secondary objectives are to assess shoulder function (internal rotation strength), safety, and patient reported outcomes. Patients will be evaluated preoperatively, at the time of surgery, 3, 6, 12 and 24 months after surgery. A total of 100 patients will be enrolled. Enrolled subjects will include adults undergoing shoulder arthroplasty, who meet the study eligibility criteria. The Tapestry Biointegrative Implant was FDA 510(k) cleared (K201572) on October 22, 2020, for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The primary analysis of subscapularis tendon repair integrity assessed by ultrasound will occur when all study subjects reach 6 months post-surgery. The goal of the analysis is to show that the tendon failure rate for subscapularis repair with Tapestry is lower than the failure rate for subscapularis repair without Tapestry a receiving surgery with the Tapestry and the literature-defined failure rate for tendon healing. Secondary endpoints will be analyzed when the last subject reaches the 24 month timepoint.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, 21 years and older.
- •Patient requires shoulder arthroplasty (anatomic or reverse) with subscapularis repair due to osteoarthritis, rotator cuff injury, rheumatoid arthritis and/or other inflammatory disorder, osteonecrosis, and/or post-traumatic injury (e.g., humerus fractures).
- •Patients healthy enough to undergo primary anatomic or reverse shoulder arthroplasty, in the opinion of the investigator;
- •Patients receiving shoulder arthroplasty with anticipated subscapularis tenotomy (ST) or subscapularis peel (SP).
- •Intact rotator cuff including subscapularis tendon for anatomic shoulder arthroplasty or a repairable subscapularis tendon for reverse shoulder arthroplasty, as determined by preoperative examination or imaging, if indicated or available preoperatively. Imaging is not required for this assessment.
- •Ability and willingness to comply with prescribed post-operative rehabilitation program.
- •Ability and willingness to comply with follow-up visit schedule.
- •Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures.
- •Ability to read, understand, and complete subject-reported outcomes in English.
排除标准
- •Shoulder arthroplasty requiring a lesser tuberosity osteotomy or revision arthroplasty.
- •Prior index shoulder surgery requiring treatment to the subscapularis.
- •Intraoperative identification of irreparable subscapularis tear (rTSA)
- •Diabetic patients with hemoglobin A1c (HbA1c) level >8% prior to surgery.
- •Patients with inflammatory arthritis or patients that are immunocompromised, or patients that have a glenoid deficiency.
- •Patients with a known history of hypersensitivity to bovine-derived materials.
- •Hypersensitivity to poly(D,L-lactide) materials.
- •Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study.
- •Currently involved in any injury litigation or worker's compensation claims relating to the index shoulder.
- •Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study.
- •History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation.
研究组 & 干预措施
Subscapularis Tendon Injuries
Tapestry Biointegrative Implant
干预措施: Tapestry Biointegrative Implant (Device)
结局指标
主要结局
Subscapularis repair integrity
时间窗: 6 months postoperatively
Assessed by ultrasound evaluation per the EMBODY-003 ultrasound procedure manual.
次要结局
- Subscapularis tendon tissue quality(6 months postoperatively)
- Internal rotation strength in the belly-press (11,12) position, measured by an electronic handheld dynamometer.(Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)
- Subscapularis repair integrity(Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)
- Adverse events(Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)
- Serious adverse events(Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)
- Serious adverse events necessitating a second surgical intervention (SSI)(Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)
- Patient Questionnaire(3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)
- Forward evaluation(Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)
- Abduction(Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)
- External rotation(Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)
- Internal rotation(Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)
- American Shoulder and Elbow Surgeon Evaluation (ASES)(Baseline/3 months/6 months/12 months/24 months postoperatively)
- Visual Analog Scale (VAS)(Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)
- Simple Shoulder Test (SST)(Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively)