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.
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.
Study Type
OBSERVATIONAL
Enrollment
54
Prospective clinical follow-up and observational data collection for adult patients who have already undergone reverse shoulder arthroplasty using the CE-marked Tipmed™ Reverse Shoulder Prosthesis System in routine clinical practice. Since participants are enrolled postoperatively, the intervention does not involve any experimental surgical assignment. No investigational or nonroutine interventions are performed as part of this observational registry. The tracked device components include a combination of humeral stems available in various dimensional configurations, humeral trays, ultra-high molecular weight polyethylene (UHMWPE) humeral cups, glenospheres, and porous + hydroxyapatite (HA)-coated baseplates with locking or non-locking fixation screws, which were tailored intraoperatively during the index surgery according to the participant's specific shoulder anatomy and bone quality.
Prospective clinical follow-up and observational data collection for adult patients who have already undergone shoulder hemiarthroplasty surgery utilizing specific components of the CE-marked Tipmed™ Shoulder Prosthesis System in routine clinical practice. Since participants are enrolled postoperatively, this observational study does not involve any active or experimental surgical intervention assigned by the protocol. No investigational or nonroutine procedures are performed as part of this study. The tracked intervention evaluates the post-surgical performance of the explicitly isolated replacement of the humeral head interacting with the patient's natural glenoid fossa. Observational data tracking focuses on the implanted configuration consisting of a modular humeral stem paired with a modular humeral head connected via a tapered conical assembly, which were selected and tailored intraoperatively during the prior surgery based on patient-specific anatomical requirements.
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
Balıkesir, Turkey (Türkiye)
RECRUITINGRepublic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Turkey (Türkiye)
NOT_YET_RECRUITINGRepublic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital
Izmir, Turkey (Türkiye)
NOT_YET_RECRUITINGDokuz Eylül University Research and Application Hospital
Izmir, Turkey (Türkiye)
NOT_YET_RECRUITINGFunctional Capacity Assessment via Modified Constant-Murley Score (MCMS)
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.
Time frame: 12 months postoperatively
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Up to 12 months postoperatively
Incidence of Clinical Complications
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.
Time frame: Up to 12 months postoperatively
Longitudinal Change in Functional Capacity via Modified Constant-Murley Score (MCMS)
Evaluation of the chronological change and improvement in shoulder functional capacity from baseline (preoperative status) across all postoperative follow-up intervals. Total MCMS scores (0-100 points) will be tracked to capture the transition rates between functional categories: Excellent (90-100), Good (80-89), Fair (70-79), and Poor (\<70). Higher scores reflect progressive functional recovery.
Time frame: 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)
Evaluation of the change in health-related quality of life from baseline across all postoperative follow-up points. The SF-12 is a generic instrument assessing eight dimensions of health status across physical and mental components. Each subscale is transformed and scored from 0 to 100, where 0 represents the worst health state and 100 represents the optimal health state. Higher values indicate a superior quality of life.
Time frame: Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, and 12 months post-operatively.
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