Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
Recruiting
Observational Study
Glenohumeral Osteoarthritis
Proximal Humerus Fracture
Rotator Cuff Arthropathy
Rheumatoid Arthritis
Avascular Necrosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 54 (estimated)
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co. · Industry
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About This Trial
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…
Trial Locations
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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 …
Contacts