A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Functional Capacity Assessment via Modified Constant-Murley Score (MCMS)
研究概览
简要总结
This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively. The study population includes adult patients who undergo reverse shoulder arthroplasty (RSA) or shoulder hemiarthroplasty (HA) using the Tipmed™ implant systems due to various clinical indications such as osteoarthritis, rotator cuff arthropathy, or proximal humerus fractures. The main objective is to gather real-world clinical evidence on the 12-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.
详细描述
The European Medical Device Regulation (MDR 2017/745) and corresponding national regulations dictate that additional safety and performance data must be systematically collected for CE-marked medical devices commercialized in the market. This clinical follow-up trial focuses on patients who are treated within routine medical practice, meaning no intervention or clinical assessment outside of standard scientific guidelines is forced upon the participants. Data regarding the preoperative status and operative details will be collected retrospectively from patient medical charts. Postoperative data will be gathered prospectively through regular follow-up visits scheduled at the 6th week, 3rd month, 6th month, and 12th month. Functional performance will be objectively quantified using the Modified Constant-Murley Score (MCMS). Quality of life metrics will be assessed via the Short Form-12 (SF-12) questionnaire. Safety reporting will encompass the continuous tracking and recording of all Adverse Events (AEs), Serious Adverse Events (SAEs), and specific device-related orthopedic complications (e.g., aseptic loosening, infection, dislocation, and scapular notch formation) over the complete 12-month postoperative follow-up period. Statistical comparisons will be managed separately for the two distinct treatment cohorts: the Reverse Shoulder Arthroplasty cohort and the Hemiarthroplasty cohort.
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
- •Individuals aged 18 years and older,
- •Male or female participants,
- •Participants who have undergone Reverse Shoulder Arthroplasty or Shoulder Hemiarthroplasty for any valid indication,
- •Participants in whose surgical procedure the Tipmed™ Shoulder Prosthesis System product configurations were utilized.
- •Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship).
- •Participants who have voluntarily signed the written Informed Consent Form (ICF).
排除标准
- •Concurrent participation in any other interventional clinical trial.
结局指标
主要结局
Functional Capacity Assessment via Modified Constant-Murley Score (MCMS)
时间窗: 12 months postoperatively
The proportion of participants achieving "excellent" (90-100 points) or "good" (80-89 points) functional outcomes based on the total MCMS score. The MCMS evaluates shoulder function across four domains: pain (15 points), activities of daily living (20 points), active range of motion (40 points), and strength (25 points). The total score ranges from 0 to 100, where higher scores indicate better functional capacity and superior clinical outcomes.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to 12 months postoperatively
Continuous monitoring, documentation, and cumulative tracking of the incidence of all adverse events (AEs) and serious adverse events (SAEs) occurring throughout the study period, regardless of their causal relationship to the investigational medical device or surgical procedure. Events will be systematically classified by severity (mild, moderate, severe), outcome, and causality pattern.
Incidence of Clinical Complications
时间窗: Up to 12 months postoperatively
Evaluation of the rate, frequency, and types of all clinical complications recorded throughout the 12-month study period. This assessment includes intraoperative complications captured retrospectively from surgical medical records (such as humeral or glenoid fractures, vascular injuries, and nerve lesions) as well as longitudinal complications documented prospectively during the postoperative follow-up phase (such as joint dislocation, component loosening, implant breakage, scapular notching, osteolysis, or deep and superficial surgical site infections) associated with the routine clinical utilization of the Tipmed™ Shoulder Prosthesis System.
次要结局
- Longitudinal Change in Functional Capacity via Modified Constant-Murley Score (MCMS)(Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, and 12 months post-operatively.)
- Change in Quality of Life via Short Form-12 (SF-12)(Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, and 12 months post-operatively.)