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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTIPMED Medical Device Manufacturing Ltd. Co.

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 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 criteria

Qualifiers

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.

Disqualifiers

Concurrent participation in any other interventional clinical trial.

Trial design

Treatments tested in this trial

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

Treatment groups

54 Participants
are divided into 2 treatment groups