Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

Avascular Necrosis Clinical Trial

Official title:

Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05002335
• Other study ID #: P06.001.05
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

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

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