Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

NCT05002335 | Active Not Recruiting

• 1 other identifier: P06.001.05
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

This is a post-market surveillance study 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

  5 years

Secondary Outcomes (5)

• Clinical outcome; Constant and Murley score

  1, 2, and 5 years

• Functional outcome: Oxford Shoulder Score

  1, 2, and 5 years

• Radiographic performance of the implants: Presence of radiolucencies

  3 months, 1, 2, and 5 years

• Quality of life assesed by EQ-5D-5L score

  1, 2, and 5 years

• Number of Intraoperative and postoperative Adverse events

  intraop, 3 months, 1, 2, and 5 years

Interventions

Medacta Shoulder System DEVICE

Performance of Total Shoulder Arthroplasty (anatomic/reverse) with Medacta Shoulder System

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 Total Shoulder Arthroplasty (anatomic/reverse) and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-market 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 (3)

AZ Sint-Jan

Bruges, 8000, Belgium

Location

AZ Sint-Lucas

Bruges, 8310, Belgium

Location

Clinique St-Luc Bouge

Namur, 5004, Belgium

Location

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

• Bart Berghs, MD

  AZ Sint-Jan (Brugge, Belgium)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: October 6, 2020
• Primary Completion: February 28, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)