Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System

NCT07678034 | Recruiting

• 2 other identifiers: INFO TPMSP2024-199
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Glenohumeral Osteoarthritis; Proximal Humerus Fracture; Rotator Cuff Arthropathy; Rheumatoid Arthritis; Avascular Necrosis

Keywords

Reverse Shoulder Arthroplasty; Shoulder Prosthesis; Shoulder Hemiarthroplasty; Post-Market Clinical Follow-Up (PMCF); Modified Constant-Murley Score

Outcome Measures

Primary Outcomes (3)

• Functional 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.

  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.

  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.

  Up to 12 months postoperatively

Secondary Outcomes (2)

• 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.

Study Arms (2)

Reverse Shoulder Arthroplasty (RSA) Cohort

Patients who undergo reverse shoulder arthroplasty using the Tipmed™ Reverse Shoulder Prosthesis System components (including Humeral Stem, Humeral Tray, Humeral Cup, Glenosphere, Baseplate, and Screws). Target enrollment: 40 participants.

Device: Tipmed™ Reverse Shoulder Prosthesis System

Shoulder Hemiarthroplasty (HA) Cohort

Patients who undergo shoulder hemiarthroplasty involving isolated replacement of the humeral head, using Tipmed™ Humeral Stems and Modular Humeral Heads interacting with the patient's natural glenoid. Target enrollment: 14 participants

Device: Tipmed™ Shoulder Prosthesis System (Hemiarthroplasty Configuration)

Interventions

Tipmed™ Reverse Shoulder Prosthesis System DEVICE

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.

Reverse Shoulder Arthroplasty (RSA) Cohort

Tipmed™ Shoulder Prosthesis System (Hemiarthroplasty Configuration) DEVICE

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.

Shoulder Hemiarthroplasty (HA) Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises adult patients aged 18 years and older, of both sexes, who have undergone either reverse shoulder arthroplasty or shoulder hemiarthroplasty at the participating multi-center orthopedic clinics. The study population is stratified into two distinct clinical cohorts representing individuals whose surgical treatment involved the standard clinical implantation of the Tipmed™ Shoulder Prosthesis System component options under specific anatomical configurations. Eligible individuals who are legally competent and provide written informed consent to allow their routine clinical findings to be documented for the study will be consecutively enrolled.

You may qualify if:

• 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).

You may not qualify if:

• Concurrent participation in any other interventional clinical trial.

Sponsors & Collaborators

• TIPMED Medical Device Manufacturing Ltd. Co.: lead

Study Sites (4)

Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital

Balıkesir, 10100, Turkey (Türkiye)

RECRUITING

Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

NOT YET RECRUITING

Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital

Izmir, 35140, Turkey (Türkiye)

NOT YET RECRUITING

Dokuz Eylül University Research and Application Hospital

Izmir, 35340, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Özgün Karakuş, Assoc. Prof.

  Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate, Atatürk City Hospital

  STUDY DIRECTOR

Central Study Contacts

Yasemin Önel, Sponsor Rep

CONTACT

+90 232 479 33 22; yaseminonel@tipmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 1, 2026
• Study Start: June 16, 2025
• Primary Completion (Estimated): March 15, 2030
• Study Completion (Estimated): June 15, 2030
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)