Clinical and Radiological Outcomes of Medacta Shoulder System FR

NCT05926622 | Recruiting

• 1 other identifier: P06.001.03
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a post-marketing surveillance on Medacta Shoulder System

Conditions

Primary Osteoarthritis; Secondary Osteoarthritis; Rotator Cuff Tear Arthropathy; Rheumatoid Arthritis Shoulder; Avascular Necrosis; Fracture; Revision of Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Survival Rate

  Kaplan Meier method

  10 years

Secondary Outcomes (5)

• Clinical outcome evaluating Constant & Murley Score

  1, 2, 5 and 10 years

• Functional outcome evaluating Oxford Shoulder Score

  1, 2, 5 and 10 years

• Radiographic performance of the implants evaluating presence of radiolucencies

  3 months, 1, 2, 5 and 10 years

• Patient evaluation quality of life

  1, 2, 5 and 10 years

• Adverse events

  up to 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring TSA and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

Clinique Générale Annecy

Annecy, 74000, France

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy; Osteonecrosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Bruno Toussaint

  Clinique Générale Annecy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arianna Girardi

CONTACT

+41 91 696 60 60; girardi@medacta.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: March 15, 2022
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2037
• Last Updated: September 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)