Active, Not Recruiting

NCT Number: NCT03547947

Clinical and Radiological Outcomes of Medacta Shoulder System

This is a post-marketing surveillance on Medacta Shoulder System

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Osteoarthritis Arthritis Avascular Necrosis Bone Diseases Chondrocalcinosis Crystal Arthropathies Fracture Fractures, Bone Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Revision of Shoulder Arthroplasty Rheumatoid Arthritis Shoulder Rotator Cuff Tear Arthropathy Secondary Osteoarthritis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du Sport et de Chirurgie Orthopédique, Marcq-en-Barœul, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Medacta Shoulder System

Device

Total Shoulder Arthroplasty

Primary outcomes

Survival rate

Time frame: 10 years

Kaplan Meier method

Secondary outcomes

Clinical outcome

Time frame: 1, 2, 5 and 10 years

Constant & Murley Score
Functional outcome

Time frame: 1, 2, 5 and 10 years

Oxford Shoulder Score
Radiographic performance of the implants

Time frame: 3 months, 1, 2, 5 and 10 years

presence of radiolucencies
Quality of life

Time frame: 1, 2, 5 and 10 years

EQ-5D
Adverse events

Time frame: up to 10 years

record of adverse event

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2031
Study completion: 2031
First posted: Jun 6, 2018
Registry last updated: Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting