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

NCT07678034

RecruitingN/A

Sponsor: TIPMED Medical Device Manufacturing Ltd. Co.

Conditions: Glenohumeral Osteoarthritis, Proximal Humerus Fracture, Rotator Cuff Arthropathy, Rheumatoid Arthritis, Avascular Necrosis

Interventions: Tipmed™ Reverse Shoulder Prosthesis System, Tipmed™ Shoulder Prosthesis System (Hemiarthroplasty Configuration)

Countries: Turkey (Türkiye)

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* Concurrent participation in any other interventional clinical trial.
Locations (4)
  • Balıkesir, Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
  • Izmir, Turkey (Türkiye)
  • Izmir, Turkey (Türkiye)