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

Recruitingn/aAges 18 Years - anyAllTIPMED Medical Device Manufacturing Ltd. Co.
NCT07678034 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Tipmed™ Reverse Shoulder Prosthesis System
  • Tipmed™ Shoulder Prosthesis System (Hemiarthroplasty Configuration)
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Where

4 sites
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
Balıkesir, Turkey (Türkiye)
Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Turkey (Türkiye)
Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital
Izmir, Turkey (Türkiye)
Dokuz Eylül University Research and Application Hospital
Izmir, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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