A Post-Market, Multicenter, Randomized Controlled Trial of the ROSA® Partial Knee System for Unicompartmental Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Accuracy of implant position
研究概览
简要总结
This is a prospective, multi-center, two-arm, randomized, controlled post-market study to evaluate and compare the clinical accuracy of component placement in robotic-assisted UKA and that of traditional methods.
详细描述
Sites will enroll participants into two separate arms for this study (rUKA and Conventional Instrumentation), following the assigned randomization. Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study and will be pre-screened for participation in the informed consent process.
The primary objective of this study is to evaluate and compare the accuracy of the ROSA® Partial Knee System in regards to implant placement with that of traditional instrumentation. This will include the assessment of the planned vs. actual component positioning.
Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results and patient reported outcome measures.
Data collection will occur at the following intervals: Pre-operative, Operative, 6-weeks, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 12-18 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 42 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participant will be randomized into one of the two available study arms, and will be blinded from treatment until surgery has occurred.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient meets the approved indications for use in accordance with product labeling for both the Persona Partial Knee System and the ROSA® Partial Knee System.
- •Body mass index ≤40 kg/m2
- •Patient is of legal age and skeletally mature
- •Patient is willing and able to provide informed consent.
- •Patient is willing to be randomized into one of two study groups of UKA performed using ROSA® and UKA using Conventional Instrumentation
- •Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol.
- •Patient qualifies for primary UKA based on investigator's clinical judgement and has an intact anterior cruciate ligament.
- •Independent of study participation, patient is a candidate for the commercially available Persona Partial Knee System.
排除标准
- •Independent of study participation, patient meets any of the contraindications for use in accordance with product labeling of the Persona Partial Knee System and/or the ROSA® Partial Knee System.
- •Orthopaedic procedure or pain management study of any joint within the last or next 6 months; furthermore, bilateral enrollment is excluded in this study.
- •Prior ACL Repair
- •Moderate to severe patello-femoral arthritis, that in the opinion of the investigator, would require patella-femoral arthroplasty.
- •Patient is unwilling to sign the Informed Consent.
- •Would, in the investigator's opinion, be unwilling or unable to comply with the postoperative care instructions or study follow-up schedule.
- •Patient is considered a member of a protected/vulnerable population (Pregnant, prisoner, mentally incompetent, etc.).
- •Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation.
- •Patient has a condition which would, in the judgement of the investigator, place the patient at undue risk or interfere with the conduct of the study.
研究组 & 干预措施
Robotic-Assisted UKA
Randomized participant will receive UKA via the ROSA Partial Knee System.
干预措施: Persona Partial Knee System (Device)
Traditional/Conventional UKA
Randomized participant will receive the UKA via Conventional/Traditional UKA Methods.
干预措施: Persona Partial Knee System (Device)
结局指标
主要结局
Accuracy of implant position
时间窗: 6 Weeks
To compare and evaluate the accuracy of implant position of robotic-arm surgical assistant (ROSA® Partial Knee System) with that of conventional instrumentation (Traditional UKA). Accuracy of the Implemented Plan will be evaluated by assessing Implant alignment post-operatively for participants enrolled for both Conventional Instrumentation and the ROSA® Partial Knee System.
次要结局
- Patient Reported Outcome Measure (KOOS-12)(24 months)
- Evaluation of range of motion(24 months)
- Evaluation of Instability(24 months)
- Numeric Pain Rating Scale (NPRS)(24 Months)
- Patient Reported Outcome Measure (Oxford Knee Score)(24 months)
- Subject Satisfaction(24 Months)
- Evaluation of Patient safety(24 months)