A Prospective, Multi-centre, Single-arm, Open-label, Post market clinical follow-up study to Evaluate Safety and Performance of the Arthroscopy Implants for Shoulder In a Real-World Setting.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- 1.Implant failure rate
研究概览
简要总结
Study Name: A Prospective, Observational, Multi-centre, Single-arm, Openlabel, Post-market Clinical Follow-up Study to Evaluate Safety and Performance of the Arthroscopy Implants for Shoulder in a Real-World Setting.
Short Title: Arthroscopy ImplantsFor Shoulder
Protocol ID, Version and Date: MHCPL/Arthroscopy Implants for Shoulder_Version 1.0.0_12- Sep-2024
Study Device: Arthroscopy Implants for Shoulder
Indication: 1.Arthroscopy implants for the shoulder: These are indicated in all connective tissue tendon repairs together with the indications for shoulder-bankart lesion, rotator cuff rupture, slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, capsular shift, capsulolabral reconstruction, biceps tendon separation, ulnar and radial collateral ligament rupture/separation, scapholunate ligament tear/separation, and ulnar or radial collateral ligament. 2. Suture: Indicated in general soft tissue approximation, and/or ligation, including orthopedic procedures.
Objective: The study aims to evaluate the safety and performance of arthroscopy implants for the shoulder in subjects who require arthroscopy implantation in a real-world setting.
Study Design: A Prospective, Observational, Multi-centre, Single-arm, Open label, Post-market Clinical Follow-up Study.
Rationale of the Study Arthroscopy implants have become essential tools in minimally invasive orthopedic procedures, particularly for treating conditions in the shoulder, elbow, and hand/wrist joints. These procedures allow for targeted interventions, offering Subjects faster recovery times, less postoperative pain, and improved mobility compared to traditional open surgeries. However, there remains a need to comprehensively assess the safety and performance of these implants in realworld settings, where subject populations may vary significantly from clinical trials.This study is designed to evaluate the safety profile and performance of arthroscopy implants in diverse subject populations undergoing shoulder, elbow, and hand/wrist surgeries.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The Subjects who are eligible for the arthroscopy system, which is used in the surgical procedures related to shoulder ligament fracture fixation, are included in the study.
- •2.Arthroscopy Shoulder System implants are intended to be used in both men and non-pregnant women of age 18 years or above.
- •3.The Subjects who require connective tissue tendon repairs for elbow, hand/wrist, and shoulder.
- •4.Subjects who require general soft tissue approximation and/or ligation, including orthopedic procedures, are included in the study.
- •5.The Subject must be willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form.
- •If the Subject is not able to write on behalf of the Subject, the Subject`s Legally acceptable representative (LAR) can fill out the informed consent.
- •When a Subject and LAR are illiterate, a literate impartial witness is required during consenting.
排除标准
- •1.Systemic or acute or chronic infection at the surgical site.
- •2.Known allergy or sensitivity to product materials.
- •4.A subject who is unwilling or unsuitable for postoperative instructions.
- •5.Pregnant women are excluded from the study.
- •6.Any medical or surgical condition that would preclude the potential benefit of the operation.
- •7.Fever or leukocytosis.
- •8.Any medical or surgical condition that could affect the potential benefit of the operation.
- •9.The Subject who is unwilling or unable to sign the Informed Consent Document will be excluded from the study.
结局指标
主要结局
1.Implant failure rate
时间窗: 1.Time Frame: Intra-operative, 3 weeks ± 10 days, 3 months ± 15 days, 6 months ± 15 days, 1 year ± 30 days, 2 years ± 30 days | 2.Time Frame: 3 weeks ± 10 days, 3 months ± 15 days, 6 months ± 15 days, 1 year ± 30 | days, 2 years ± 30 days | 3.Time Frame: Intraoperative
2.Reoperation rate
时间窗: 1.Time Frame: Intra-operative, 3 weeks ± 10 days, 3 months ± 15 days, 6 months ± 15 days, 1 year ± 30 days, 2 years ± 30 days | 2.Time Frame: 3 weeks ± 10 days, 3 months ± 15 days, 6 months ± 15 days, 1 year ± 30 | days, 2 years ± 30 days | 3.Time Frame: Intraoperative
3.Intra-operative Complications
时间窗: 1.Time Frame: Intra-operative, 3 weeks ± 10 days, 3 months ± 15 days, 6 months ± 15 days, 1 year ± 30 days, 2 years ± 30 days | 2.Time Frame: 3 weeks ± 10 days, 3 months ± 15 days, 6 months ± 15 days, 1 year ± 30 | days, 2 years ± 30 days | 3.Time Frame: Intraoperative
次要结局
- 1.Implant failure rate(2.Sugaya Score)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd