Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

This is a post-market surveillance study on Medacta Shoulder System

Study Overview

• Status: Active, not recruiting
• Conditions: Avascular Necrosis; Fracture; Primary Osteoarthritis; Secondary Osteoarthritis; Rotator Cuff Tear Arthropathy; Rheumatoid Arthritis Shoulder; Revision of Shoulder Arthroplasty
• Intervention / Treatment: Device: Medacta Shoulder System

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Belgium
  • Bruges, Belgium, 8000
    • AZ Sint-Jan
  • Bruges, Belgium, 8310
    • AZ Sint-Lucas
  • Namur, Belgium, 5004
    • Clinique St-Luc Bouge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• Patients older than 18 years

• Patient with one of the following diagnosis:

  1. Primary osteoarthritis
  2. Secondary osteoarthritis
  3. Cuff tear arthropathy; insufficient rotator cuff
  4. Acute fracture (<21d)
  5. Rheumatoid or inflammatory arthritis
  6. Avascular necrosis
  7. Other posttraumatic condition
  8. 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	Kaplan Meier method	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome; Constant and Murley score	Constant & Murley Score: Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. The pain experienced during normal activities of daily living was scored as: no pain = 15 points, mild = 10, moderate = 5 and severe = 0 points.	1, 2, and 5 years
Functional outcome: Oxford Shoulder Score	Oxford Shoulder Score: It contains 12 items, each with 5 potential answers. A mark between 1 (best/fewest symptoms) and 5 (worst/most severe) is awarded to correspond to the patient's symptoms. The combined total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability	1, 2, and 5 years
Radiographic performance of the implants: Presence of radiolucencies	Presence of radiolucencies	3 months, 1, 2, and 5 years
Quality of life assesed by EQ-5D-5L score	EQ-5D-5L score: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.	1, 2, and 5 years
Number of Intraoperative and postoperative Adverse events	Intraoperative and postoperative adverse events	intraop, 3 months, 1, 2, and 5 years

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Bart Berghs, MD, AZ Sint-Jan (Brugge, Belgium)

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2020
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Crystal Arthropathies; Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Arthritis; Joint Diseases; Necrosis; Chondrocalcinosis; Pathological Conditions, Signs and Symptoms; Rotator Cuff Tear Arthropathy; Fractures, Bone; Osteonecrosis
• Other Study ID Numbers: P06.001.05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No