Post-market Clinical Follow-up Study to Collect Safety, Performance and Clinical Benefits of the ComposiTCP™ Suture Anchors Double Loaded With BroadBand Tape, Sliding
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff)
研究概览
简要总结
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding implants when used in rotator cuff repair.
The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient.
The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Oxford Shoulder Score and EQ-5D-5L) at 1 year post-operative.
The safety will be assessed by monitoring the incidence and frequency of device- and/or procedure-related adverse events.
详细描述
The ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding implants are intended for use in rotator cuff repairs. They are intended for for the reattachment of soft tissue to bone.
Up to two sites will be involved in this study. The aim is to include a total of 43 consecutive series cases who received the device. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1 years post-op, the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was treated with the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding for rotator cuff repair;
- •At least 18 years old and skeletally mature;
- •Willing and able to comply with the study procedures;
- •Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
- •Subject is able to read and understand the ICF and has voluntarily provided written informed consent or non-opposition.
排除标准
- •Subject is vulnerable (is unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response);
- •The subject is unwilling or unable to give consent or to comply with the follow-up program;
- •Subject meets any contraindications of the appropriate Instruction for Use;
- •Off-Label Use.
研究组 & 干预措施
Patients who received the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding
No specific interventions will be administered.
结局指标
主要结局
Assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff)
时间窗: From operation to study completion, 0-1 year
The investigator will clinically evaluate at 1 year follow-up visit if soft tissue to bone healing has occurred by the absence of device-related revisions and re-tears that were not previously reported. The following question will be asked to the investigator: "Did soft tissue to bone healing occur"? If "yes" is answered, then the soft tissue to bone healing is successful, if "no" is answered, then the soft tissue to bone healing is considered unsuccessful.
次要结局
- The incidence and frequency of device and/or procedure related adverse events(From operation to study completion, 0-1 year)
- Oxford Shoulder Score(From surgery until study completion, 0-1 year)
- EQ-5D-5L Score(From operation to study completion, 0-1 year)