Follow-up of adults with a Tipmed shoulder replacement implant
Follows adults with shoulder replacements for one year to check safety and function.
Plain-language title generated from the registry record
Registry title: Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
Key facts
- Where
- Balıkesir, Istanbul, and Izmir, TürkiyeSee the 4 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had shoulder replacement surgery with the Tipmed™ Shoulder Prosthesis System, either reverse shoulder or half shoulder replacement.
- Age
- 18 years and older
- Sex
- Men and women can join.
- Disease stage
- Any valid reason for reverse shoulder arthroplasty or shoulder hemiarthroplasty. The conditions listed include shoulder osteoarthritis, rotator cuff arthropathy, proximal humerus fracture, rheumatoid arthritis and avascular necrosis.
- Earlier treatment
- People must already have had reverse shoulder arthroplasty or shoulder hemiarthroplasty, using the Tipmed™ Shoulder Prosthesis System.
Main reasons for not taking part
- Taking part in another interventional clinical trial at the same time
- People who are legally restricted, such as military personnel, convicts or people under legal guardianship
- People who have not signed the written informed consent form
Read by machine on 13 November 2026.
Where in Türkiye
- Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City HospitalBalıkesir, TürkiyeContact: Özgün Karakuş, Assoc. Prof.Taking people
- Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research HospitalIstanbul, TürkiyeContact: Oğuzhan Bulut, MD, Spec.Not yet recruiting
- Dokuz Eylül University Research and Application HospitalIzmir, TürkiyeContact: Onur Başçı, Assoc. Prof.Not yet recruiting
- Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research HospitalIzmir, TürkiyeContact: Sercan Çapkın, MD, Spec.Not yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- TIPMED Medical Device Manufacturing Ltd. Co.
- Trial code
- NCT07678034
- Record updated
- 1 July 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
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.
Inclusion: 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).
Exclusion: Concurrent participation in any other interventional clinical trial.