Arthroscopy Implants for Knee:A Prospective, Observational, Multi-centre, Single-arm, Open-label, Post-market Clinical Followup Study to Evaluate Safety and Performance of the Arthroscopy Implants for Knee in a RealWorld Setting.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 107
- 试验地点
- 4
- 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 Knee in a RealWorld Setting.
Short Title: Arthroscopy Implants for Knee
Objective: The study aims to evaluate the safety and performance of arthroscopy implants in participants undergoing knee surgeries.
Study Design: A Prospective, Observational, Multi-centre, Single-arm, Openlabel, 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 participants faster recovery times, less post- operative 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 real- world settings, where participant populations may vary significantly from clinical trials. This study is designed to evaluate the safety and performance of arthroscopy implants in Participants undergoing knee 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
- •Arthroscopy Knee System implants are intended to be used in both men and non-pregnant women of age 18 years or above.
- •The Participants who are eligible for the arthroscopy system which is used in the surgical procedures related to knee ligament fracture fixation are included in the study.
- •The Participants who require connective tissue tendon repairs for the knees.
- •Participants who require the attachment of soft tissue grafts or bone-tendon grafts to the tibia and/or femur during cruciate ligament reconstruction surgeries and fixation of soft tissue.
- •The patient is willing and able to comply with postoperative scheduled clinical evaluations.
排除标准
- •1.Systemic or acute or chronic infection at the surgical site.
- •Known allergy or sensitivity to product materials.
- •Any medical or surgical condition that would preclude the potential benefit of the operation.
- •Fever or leukocytosis.
- •Long-term infection, pregnancy and nursing, radiation bone therapy, cardiovascular diseases, metabolic bone disease, renal diseases, and pediatric Participants should not be included in the study.
- •Participants within whom cooperation or mental competence is lacking, thereby reducing Participants compliance.
- •The Participants, being considered for treatment by a doctor, would not comply with the follow-up schedule.
- •Participants who is unwilling or unsuitable for postoperative instructions.
- •The Participants 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, 3 months, 6 months, 1 year, 2 years | 2.Time Frame: 3 weeks, 3 months, 6 months, 1 year, 2 years | 3.Time Frame: Pre-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years
2.Reoperation rate
时间窗: 1.Time Frame: Intra-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years | 2.Time Frame: 3 weeks, 3 months, 6 months, 1 year, 2 years | 3.Time Frame: Pre-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years
3.Physical Function
时间窗: 1.Time Frame: Intra-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years | 2.Time Frame: 3 weeks, 3 months, 6 months, 1 year, 2 years | 3.Time Frame: Pre-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years
次要结局
- 1.Implant failure rate(2.Reoperation rate)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd