A prospective, single-arm, multi-centre, observational study to evaluate the safety and performance of Opulentâ„¢ Knee System (Uni Knee) in patients who underwent Uni Knee Replacement in the real-world setting.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 194
- 试验地点
- 4
- 主要终点
- 1.Range of Motion
研究概览
简要总结
OpT Uni Knee: A prospective, single-arm, multi-centre, observational study to evaluate the safety and performance of Opulentâ„¢ Knee System (Uni Knee) in patients who underwent Uni Knee Replacement in the real-world setting.
Device Used: Opulentâ„¢ Knee System (Uni Knee)
Objectives: The objective of the study is to evaluate the safety and performance of the Opulentâ„¢ Knee System (Uni Knee) in patients who underwent Uni Knee Replacement in a real-world setting.
Study Design: A prospective, single-arm, multi-centre, observational study, realworld, post-marketing surveillance.
Rationale of the Study: The study design is a prospective, single-arm, multi-centre, observational study, post-marketing surveillance of the commercially available Opulent™ Knee System (Uni Knee). The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical and radiographic evaluations prior to their Uni Knee arthroplasty. The postoperative clinical and radiographic evaluations will be conducted at 3 weeks ± 3 days, 3 months ± 15 days, 6 months ± 15 days, 1 year ± 30 days, 2 years ± 30 days, 3 years ± 30 days, 5 years ± 30 days. The primary objective of this study is to obtain implant/component survivorship and clinical outcomes data for commercially available Opulent™ Knee System (Uni Knee) used in Uni Knee arthroplasty. (The assessment will include implant survivorship and clinical performance by pain and function, Range of motion, quality of life data, radiographic parameters, and survivorship).
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
- •The Subject is a male or non-pregnant female aged 18 years or older at the time of study.
- •The Subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent Form in the presence of an impartial witness.
- •The Subject is eligible for a partial arthroplasty only.
- •The Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
- •The Subject has non-inflammatory degenerative joint disease, including osteoarthritis, traumatic arthritis, or avascular necrosis.
- •The Subject has an inflammatory degenerative joint disease, excluding severe rheumatoid arthritis.
- •The Subject has functional deformities such as varus, valgus, or flexion deformities.
- •The Subject has fractures that are unmanageable using other techniques.
- •The Subject has a correction of functional deformities.
排除标准
- •The Subject with a BMI greater than or equal to
- •Subjects with a known sensitivity to device materials.
- •The Subject is unwilling or unable to sign the Informed Consent Document.
- •The Subject has a history of infection in the affected joint that may affect the function of the implanted prosthetic.
- •Subjects with less-than-optimal bone stock on femoral or tibial surfaces resulting from a history of disease, infection, or prior surgical procedures non-conducive towards adequate support for the implantation.
- •Any Subject has compromised skeletal bone quality.
- •Any Subject has neuropathic disease that adversely affects the prosthetic joint.
- •Any Subject has osteoporosis or a deficiency of musculature that compromises the affected limb.
- •Any Subject with pain-free and stable arthrodesis in an adequate functional position.
- •Any Subject with unstable knee joint secondary to negative collateral ligament integrity.
- •Any Subject, being considered for treatment by a doctor, would not comply with the follow-up schedule.
- •Subjects with rheumatoid arthritis shall be excluded.
结局指标
主要结局
1.Range of Motion
时间窗: 1. Time Frame: Pre-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years | 2. Discharge, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years | 3. Time Frame: 3 weeks, 3 | months, 6 months, 1 year, 2 | years, 3 years, 5 years | 4. Time Frame: During | procedure
2.Implant Survivorship
时间窗: 1. Time Frame: Pre-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years | 2. Discharge, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years | 3. Time Frame: 3 weeks, 3 | months, 6 months, 1 year, 2 | years, 3 years, 5 years | 4. Time Frame: During | procedure
3. Cumulative Revision Rate
时间窗: 1. Time Frame: Pre-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years | 2. Discharge, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years | 3. Time Frame: 3 weeks, 3 | months, 6 months, 1 year, 2 | years, 3 years, 5 years | 4. Time Frame: During | procedure
4. Intra-operative complications
时间窗: 1. Time Frame: Pre-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years | 2. Discharge, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years | 3. Time Frame: 3 weeks, 3 | months, 6 months, 1 year, 2 | years, 3 years, 5 years | 4. Time Frame: During | procedure
次要结局
- 1. Knee Society Score(2. Oxford Knee Score)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd