MissoBOT-A prospective, single-arm, multi-center, post-marketing surveillance study to evaluate the safety and efficacy of the MISSOâ„¢ ROBOTIC SYSTEM.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 9
- 主要终点
- 1. Component Alignment - TKA
研究概览
简要总结
MissoBOT: A Prospective, Single-arm, Multi-Center, Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of the MISSO ROBOTIC SYSTEM.
Study Objectives: To Evaluate the Safety and Efficacy of the MISSO ROBOTIC SYSTEM has application throughout the MISSO and is intended for use as a stereotaxic device for knee arthroplasty.
Study Design: A Prospective, Single-arm, Multi-Center, Post-Marketing Surveillance Study.
Background: The surgeon uses a bone saw to remove the arthritically damaged areas at the bottom of the femur and the top of the tibia. Each bone is reshaped to fit its new prosthesis exactly. The procedure is performed manually by the orthopedic surgeons. The MISSO is intended for use as a stereotaxic device for knee arthroplasty. It is to assist a surgeon in planning pre-operation using medical diagnostic images obtained from the patient and to provide orientation and reference information during intra-operative procedures. The surgical tools, under the supervision of the surgeon, perform the pre-operative surgical plan.
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 subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form.
- •2.In the case of a subject and LAR being illiterate a literate impartial witness is required during consenting.
- •3.If the subject is not able to write on behalf of the subject the subjects LAR (Legally acceptable representative) can fill out the informed consent.
- •4.The subject is willing and able to comply with postoperative scheduled clinical evaluations.
- •5.Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •6.The inclusion criteria for the use of MISSO as a stereotaxic device for knee arthroplasty include surgeons seeking assistance in preoperative planning using patients medical diagnostic images and requiring orientation and reference information during intraoperative procedures.
- •7.Only the participating surgeons who oversee the utilization of surgical tools will execute the preoperative surgical plan while using MISSO as a stereotaxic device for knee arthroplasty.
排除标准
- •1.Without informed consent, the subject is not eligible for the study
- •If the robotic system of any other brand is used, the subject shouldn’t be included in the study
- •Individuals with any active infections are excluded.
- •Individuals exhibiting skeletal immaturity are not considered.
- •Individuals who can be in situations wherein strong infrared sources or infrared reflectors are present in the vicinity of the trackers are excluded.
- •Pregnant ladies shall be excluded from the study.
- •Subjects with a short life expectancy of fewer than 1 year
- •Subject with a known sensitivity to device materials
- •Subjects with neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
- •Subjects with a history of deep vein thrombosis or other thrombotic disorders
- •Subjects with conditions such as severe Parkinsonism and locomotor ataxia that would affect their locomotor stability and interfere with the assessment of the Range of Motion of the target knee
- •Subjects with severe osteoporosis (T score greater than -3) shall be excluded.
结局指标
主要结局
1. Component Alignment - TKA
时间窗: 1. Time Frame: Post-operative | (Day-0) | 2. TimeFrame:3months | 3. Time Frame: 3 weeks,3months ,6months, 1 year | 4. Time Frame :Pre-Cut and Intraoperative measurements | 5. Time Frame: Intra-operative | 6. TimeFrame:Intra-operative | 7. TimeFrame:PreoperativePlan,3weeks,3months,6months, | 1 year | 8. Time Frame: Postoperative, 3 weeks, 3months, 6months, 1 year
2. Component Alignment-TKA
时间窗: 1. Time Frame: Post-operative | (Day-0) | 2. TimeFrame:3months | 3. Time Frame: 3 weeks,3months ,6months, 1 year | 4. Time Frame :Pre-Cut and Intraoperative measurements | 5. Time Frame: Intra-operative | 6. TimeFrame:Intra-operative | 7. TimeFrame:PreoperativePlan,3weeks,3months,6months, | 1 year | 8. Time Frame: Postoperative, 3 weeks, 3months, 6months, 1 year
3. Component Alignment - TKA
时间窗: 1. Time Frame: Post-operative | (Day-0) | 2. TimeFrame:3months | 3. Time Frame: 3 weeks,3months ,6months, 1 year | 4. Time Frame :Pre-Cut and Intraoperative measurements | 5. Time Frame: Intra-operative | 6. TimeFrame:Intra-operative | 7. TimeFrame:PreoperativePlan,3weeks,3months,6months, | 1 year | 8. Time Frame: Postoperative, 3 weeks, 3months, 6months, 1 year
4. Bonecutaccuracy
时间窗: 1. Time Frame: Post-operative | (Day-0) | 2. TimeFrame:3months | 3. Time Frame: 3 weeks,3months ,6months, 1 year | 4. Time Frame :Pre-Cut and Intraoperative measurements | 5. Time Frame: Intra-operative | 6. TimeFrame:Intra-operative | 7. TimeFrame:PreoperativePlan,3weeks,3months,6months, | 1 year | 8. Time Frame: Postoperative, 3 weeks, 3months, 6months, 1 year
5. Intra-Operative Complications
时间窗: 1. Time Frame: Post-operative | (Day-0) | 2. TimeFrame:3months | 3. Time Frame: 3 weeks,3months ,6months, 1 year | 4. Time Frame :Pre-Cut and Intraoperative measurements | 5. Time Frame: Intra-operative | 6. TimeFrame:Intra-operative | 7. TimeFrame:PreoperativePlan,3weeks,3months,6months, | 1 year | 8. Time Frame: Postoperative, 3 weeks, 3months, 6months, 1 year
6. Post-resection Soft Tissue Release(STR)and reosteotomy
时间窗: 1. Time Frame: Post-operative | (Day-0) | 2. TimeFrame:3months | 3. Time Frame: 3 weeks,3months ,6months, 1 year | 4. Time Frame :Pre-Cut and Intraoperative measurements | 5. Time Frame: Intra-operative | 6. TimeFrame:Intra-operative | 7. TimeFrame:PreoperativePlan,3weeks,3months,6months, | 1 year | 8. Time Frame: Postoperative, 3 weeks, 3months, 6months, 1 year
7. Accuracy of total knee arthroplasty component placement
时间窗: 1. Time Frame: Post-operative | (Day-0) | 2. TimeFrame:3months | 3. Time Frame: 3 weeks,3months ,6months, 1 year | 4. Time Frame :Pre-Cut and Intraoperative measurements | 5. Time Frame: Intra-operative | 6. TimeFrame:Intra-operative | 7. TimeFrame:PreoperativePlan,3weeks,3months,6months, | 1 year | 8. Time Frame: Postoperative, 3 weeks, 3months, 6months, 1 year
8. Adverse Events
时间窗: 1. Time Frame: Post-operative | (Day-0) | 2. TimeFrame:3months | 3. Time Frame: 3 weeks,3months ,6months, 1 year | 4. Time Frame :Pre-Cut and Intraoperative measurements | 5. Time Frame: Intra-operative | 6. TimeFrame:Intra-operative | 7. TimeFrame:PreoperativePlan,3weeks,3months,6months, | 1 year | 8. Time Frame: Postoperative, 3 weeks, 3months, 6months, 1 year
次要结局
- 1.Radiographic assessment of Limb Alignment(2.Radiographic assessment of prosthesisposition)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd