Clinical and Radiological Outcomes of Medacta Shoulder System

Recruiting

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

• Registration Number: NCT03547947
• Lead Sponsor: Medacta International SA

Brief Summary

This is a post-marketing surveillance on Medacta Shoulder System

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-06
• Study Start: 2018-06-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-13
• Primary Completion: 2031-04
• Study Completion: 2031-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate	10 years	Kaplan Meier method

Secondary Outcome Measures

Name	Time	Method
Adverse events	up to 10 years	record of adverse event
Quality of life	1, 2, 5 and 10 years	EQ-5D
Functional outcome	1, 2, 5 and 10 years	Oxford Shoulder Score
Clinical outcome	1, 2, 5 and 10 years	Constant \& Murley Score
Radiographic performance of the implants	3 months, 1, 2, 5 and 10 years	presence of radiolucencies

Trial Locations

Locations (6)

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

Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation; 🇩🇪 München, Germany

Inselspital; 🇨🇭 Bern, Switzerland

Lindenhofspital; 🇨🇭 Bern, Switzerland

Orthopädie Sonnenhof; 🇨🇭 Bern, Switzerland

Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen,; 🇨🇭 Saint Gallen, Switzerland