A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Turkey
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
RECRUITING
Balıkesir
Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital
NOT_YET_RECRUITING
Istanbul
Dokuz Eylül University Research and Application Hospital
NOT_YET_RECRUITING
Izmir
Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital
NOT_YET_RECRUITING
Izmir
Contact Information
Primary
Yasemin Önel, Sponsor Rep
yaseminonel@tipmed.com
+90 232 479 33 22
Time Frame
Start Date:2025-06-16
Estimated Completion Date:2030-06-15
Participants
Target number of participants:54
Treatments
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.
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