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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05002335
Other study ID # P06.001.05
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 6, 2020
Est. completion date December 31, 2027

Study information

Verified date March 2023
Source Medacta International SA
Contact Denise Falcone
Phone +41916966060
Email falcone@medacta.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2027
Est. primary completion date February 28, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
Belgium AZ Sint-Jan Brugge
Belgium AZ Sint-Lucas Brugge
Belgium Clinique St-Luc Bouge Namur

Sponsors (1)

Lead Sponsor Collaborator
Medacta International SA

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival rate Kaplan Meier method 5 years
Secondary 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
Secondary 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
Secondary Radiographic performance of the implants: Presence of radiolucencies Presence of radiolucencies 3 months, 1, 2, and 5 years
Secondary 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
Secondary Number of Intraoperative and postoperative Adverse events Intraoperative and postoperative adverse events intraop, 3 months, 1, 2, and 5 years
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