Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Rotator Cuff Tear
- 发起方
- Xiros Ltd
- 入组人数
- 37
- 主要终点
- Device Related or Procedure Related Adverse Events
- 状态
- 尚未招募
- 最后更新
- 3个月前
概览
简要总结
This is a clinical investigation study. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions.
The medical device in this study is already on the market and is manufactured by Xiros Ltd.
The Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair.
The study will collect data on patients who meet the entry criteria and have received the device.
This is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the is expected to be 3 years.
A minimum of 37 patients will be enrolled into the study. Patients will be enrolled at a study specific follow up visit 2-2.5 years after implant, and data for baseline and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.
详细描述
This is a clinical investigation study with both a prospective and retrospective study design. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions. The medical device in this study is already on the market and is manufactured by Xiros Ltd. The Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair. The study will collect data on patients who meet the entry criteria and have received the device. This is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the is expected to be 3 years. A minimum of 37 patients will be enrolled into the study. Patients will be enrolled at a study specific follow up visit 2-2.5 years after implant, and data for baseline and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.
研究者
入排标准
入选标准
- •Patient has been treated using a Pitch-Patch device for augmentation or reinforcement of the rotator cuff 2-2.5years prior to enrolment.
- •Patient has a baseline Constant Murley Score (CMS), assessed within 30 days prior to implantation of the device.
- •Patient must be 16 years old or above.
- •Patient is willing to participate in the study, and having been informed of the nature of the study, has provided written informed consent as approved by the Ethics Committee (EC).
排除标准
- •\- The Pitch-Patch has been used outside its intended use.
结局指标
主要结局
Device Related or Procedure Related Adverse Events
时间窗: 2 years
Device related and/ or procedure related adverse events up to at least 2 years after surgery
Constant Murley Score (CMS)
时间窗: 2 years
The primary performance endpoint is the change in the CMS from baseline (if available) and between post-surgery timepoints up to at least 2 years after surgery. CMS comprises of 4 parts: Pain reported by the patient (max 15 points), activities of daily living reported by patient (max 20 points), range of movement assess by the examiner (max 40 points), and strength assessed by the examiner (max 25 points). Scores range from 0 to 100. Better functioning shoulders will have a greater number of points, up to a maximum of 100 points.
次要结局
- Normal Daily Work/ Normal Recreational Activities(2 years)
- Tissue Integration into the Pitch Patch(2 years)
- Re-tear Rate(2 years)
- Subjective Shoulder Value(2 years)
- Constant Murley Score (subscale)(2 years)
- Tegner Score(2 years)