Observing outcomes of the Medacta Shoulder System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on the clinical and radiological outcomes of the Medacta Shoulder System in patients with various shoulder conditions. It aims to gather data on the effectiveness and safety of this shoulder implant in real-world settings following its market release. Patients over 18 years old with specific shoulder diagnoses will be monitored for their recovery and overall satisfaction post-surgery. The study will include a diverse range of shoulder-related conditions to assess the implant's performance across different patient profiles.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients older than 18 years
* Patient with one of the following diagnosis:

Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (\<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty

Exclusion Criteria:

* Patients with malignant diseases (at the time of surgery)
* Patients with proven or suspect infections (at the time of surgery)
* Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)
* Patients with known incompatibility or allergy to products materials (at the time of surgery)

Where it's running

• Clinique du Sport et de Chirurgie Orthopédique
  Marcq-en-Barœul, France Recruiting
• Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation
  München, Germany Recruiting
• Orthopädie Sonnenhof
  Bern, Switzerland Recruiting
• Inselspital
  Bern, Switzerland Recruiting
• Lindenhofspital
  Bern, Switzerland Recruiting
• Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen,
  Saint Gallen, Switzerland Recruiting

Study contacts

• Principal investigator: Matthias Zumstein, Prof Dr. Med — Insel Gruppe AG, University Hospital Bern
• Study coordinator: Mara Colombo
• Email: colombo@medacta.ch
• Phone: 0041916966060

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tipmed Shoulder Prosthesis PMCF: safety and outcomes after shoulder replacement

  This PMCF study tests the safety and function of the Tipmed shoulder prosthesis in adults undergoing reverse shoulder or hemiarthroplasty in real-world practice.

  Recruiting TIPMED Medical Device Manufacturing Ltd. Co. · Balıkesir and 3 other locations · NCT07678034

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.