A Prospective, Multi-center, Post-market, Registry-based Evaluation of the Clinical Outcomes in Patients Receiving a Stryker Implant With Use of the Mako Robotic-Arm Assisted System (Mako-MORE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 950
- 试验地点
- 5
- 主要终点
- Implant Survivorship at 2 Years Postoperative
研究概览
简要总结
This is a prospective, post-market, multi-center, registry-based observational study designed to collect real-world clinical data on patients undergoing joint arthroplasty with Stryker implants, with or without the use of the Mako Robotic-Arm Assisted System. The registry will collect prospective data on patient characteristics, procedural details, patient-reported outcomes, radiographic assessments, and adverse events. Patients will be enrolled into procedure-specific cohorts and followed for up to five years postoperatively.
详细描述
The Mako-MORE Registry is a prospective, post-market, multi-center registry-based evaluation of the Mako Robotic-Arm Assisted System used in total hip arthroplasty (primary and revision), total knee arthroplasty, and partial knee arthroplasty. The registry includes both Mako-assisted and manual arthroplasty cohorts to support real-world data collection.
Eligible patients undergoing arthroplasty using cleared Mako SmartRobotics™ applications or manual procedures will be enrolled and followed according to standard-of-care clinical practice. Data collected include demographics, procedural details, patient-reported outcomes, health utility measures, radiographic imaging, and adverse event information. Follow-up assessments will occur from the preoperative period through five years postoperatively.
The primary purpose of the registry is observational and descriptive. No investigational devices or experimental interventions are used, and all procedures are performed in accordance with FDA-cleared labeling and institutional standards of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is skeletally mature, and ≥ 18 years old.
- •The Subject has signed and dated an IRB/EC approved, study specific Informed Patient Consent Form (ICF).
- •The subject is scheduled to undergo manual arthroplasty or Mako Robotic-Arm Assisted Arthroplasty according to IFU.
- •The subject is willing and able to comply with postoperative scheduled clinical evaluations.
排除标准
- •The subject is not able to express his/her consent as deemed by the investigator.
- •The subject is not able to fulfill a self-assessment questionnaire or follow-up visits as deemed by the investigator.
- •The subject is a prisoner.
- •Per surgeon discretion the subject is not a candidate for the study.
- •The subject is pregnant or breastfeeding.
结局指标
主要结局
Implant Survivorship at 2 Years Postoperative
时间窗: 2-years postoperative
To evaluate survival rate at 2-years postoperative for Stryker devices implanted with the Mako Robotic-Arm Assisted System. Survival is defined as the absence of revision for implanted devices.
次要结局
- Implant Survivorship at 5 Years Postoperative(5-years postoperative)
- Change in Patient-Reported Outcomes From Baseline(5-years postoperative)