Quattro® X Suture Anchor With BroadBand™ Tape Post Market Clinical Follow-up Study (Incl. Instruments)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 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 Quattro® X Suture Anchor with BroadBand™ Tape and Instruments 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. Constant & Murley 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 Quattro® X Suture Anchor with BroadBand™ Tape is intended for use in rotator cuff repairs. It is intended for for the reattachment of soft tissue to bone.
Up to three sites will be involved in this study. The aim is to include a total of 109 consecutive series cases who received the Quattro® X Suture Anchor with BroadBand™ Tape. 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 treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair;
- •Older than 18 years 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.
排除标准
- •Presence of infection;
- •Insufficient or immature bone;
- •Insufficient blood supply or previous infections which may hinder the healing process;
- •Foreign body sensitivity;
- •Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
- •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.
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
- Constant and Murley Score(From operation to study completion, 0-1 year)
- EQ-5D-5L Score(From operation to study completion, 0-1 year)
- Patient Satisfaction(1 year after surgery)
- Assessment of Safety(From operation to study completion, 0-1 year)
- Subjective Shoulder Value(From operation to study completion, 0-1 year)
- Would The Patient Have This Surgery Again?(1 year after surgery)
- Pain / Anti-Inflammatory Medication(1 year after surgery)