NCT06287853暂停不适用
A Multi-Center, Prospective Post Market Clinical Follow-Up Evaluating Arthroscopic Rotator Cuff Repair Augmented With TAPESTRY® Biointegrative Implant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 170
- 试验地点
- 3
- 主要终点
- Re-tear rate after arthroscopic rotator cuff repair
研究概览
简要总结
The study design is a prospective, multi-center, single-arm, non-randomized, and noncontrolled post market clinical follow-up study involving orthopedic surgeons skilled in arthroscopic rotator cuff repair as determined by the Sponsor.
详细描述
The objectives of the study are to calculate the overall clinical success rate, the performance, and clinical benefits, and confirm the safety of the Tapestry RC Biointegrative Implant System.
- The clinical success will be evaluated by absence of rotator cuff re-tear.
- The performance and clinical benefits will be evaluated by functional outcomes measured using standard scoring systems such as the American Shoulder and Elbow Surgeons Shoulder Score (ASES), Visual Analogue Scale (VAS), Constant-Murley Score (CMS), Single Assessment Numeric Evaluation (SANE), Return to Activity, Patient Satisfaction, EQ-5D-5L, and rotator cuff repair outcomes measured using MRI evaluation for repair integrity, quality, tendon tissue thickness and regeneration.
- The safety of the Tapestry RC Biointegrative Implant System will be assessed by monitoring the frequency and incidence of adverse events.
The primary endpoint of this study is defined by the rotator cuff re-tear rate post-operatively. This will be measured against the success criteria of the re-tear rate in 18.3% of cases at two years.
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
- 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 with a diagnosis of a symptomatic primary partial-thickness or full-thickness tear of the supraspinatus and/or infraspinatus tendons amenable to repair that meets one of the following criteria:
- •Partial-thickness tear planned for standalone treatment (no surgical repair with sutures/suture anchors) with the Tapestry Biointegrative Implant, or
- •Full-thickness tear planned for treatment with the Tapestry Biointegrative Implant as an adjunct to surgical repair (single or double row repair with sutures/suture anchors);
- •Patient is able and willing to complete the protocol required follow-up;
- •Patient is able and willing to sign the IRB approved informed consent;
- •Independent of study participation, patient qualifies for arthroscopic rotator cuff repair and meets the approved indications for use of the commercially available Tapestry RC Biointegrative Implant System
排除标准
- •Hypersensitivity to bovine-derived materials or poly(D,L-lactide) materials;
- •Patient with an irreparable or partially reparable rotator cuff tear;
- •Revision rotator cuff repair;
- •Off-label use of the study device;
- •Patient is known to be pregnant or nursing;
- •Patient is a prisoner;
- •Patient is a known alcohol or drug abuser;
- •Patient has a psychiatric illness, neurologic disorder, or cognitive deficit that will not allow for proper informed consent or compliance with study requirements;
- •Patient is unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
- •Patient is unwilling or unable to give consent or to comply with the follow-up program;
- •Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
结局指标
主要结局
Re-tear rate after arthroscopic rotator cuff repair
时间窗: 6-month Post-operatively
Assessed by MRI evaluation at 6 months post-operatively defined using Sugaya classification system.
次要结局
- The American Shoulder and Elbow Surgeons (ASES) Score(Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively)
- The Single Assessment Numeric Evaluation (SANE) Score(Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively)
- Adverse Event(Screening/Pre-Op, Op, Imme-Post-op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively)
- EQ-5D-5L (EuroQol)(Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively)
- Patient Satisfaction(6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively)
- MRI Goutallier Classification(Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively)
- Constant-Murley Score (CMS)(Screening/Pre-Op, 6 weeks, 3-month, 6-month, 12-month 24-month Post-operatively)
- Return to Work/Activity(6 weeks, 3-month, 6-month, 12-month 24-month post-operatively)
- MRI Sugaya Classification(Screening/Pre-Op, 3-month, 6-month, 12-month 24-month post-operatively)
研究者
研究点 (3)
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