Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

Recruiting

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

• Registration Number: NCT05002335
• Lead Sponsor: Medacta International SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-06
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16
• Primary Completion: 2026-02-28
• Study Completion: 2027-12-31

Recruitment & Eligibility

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

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate	5 years	Kaplan Meier method

Secondary Outcome Measures

Name	Time	Method
Radiographic performance of the implants: Presence of radiolucencies	3 months, 1, 2, and 5 years	Presence of radiolucencies
Number of Intraoperative and postoperative Adverse events	intraop, 3 months, 1, 2, and 5 years	Intraoperative and postoperative adverse events
Clinical outcome; Constant and Murley score	1, 2, and 5 years	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.
Functional outcome: Oxford Shoulder Score	1, 2, and 5 years	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
Quality of life assesed by EQ-5D-5L score	1, 2, and 5 years	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.

Trial Locations

Locations (3)

AZ Sint-Jan; 🇧🇪 Brugge, Belgium

AZ Sint-Lucas; 🇧🇪 Brugge, Belgium

Clinique St-Luc Bouge; 🇧🇪 Namur, Belgium