Clinical and Radiological Outcomes of Medacta Shoulder System FR

Recruiting

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

• Registration Number: NCT05926622
• Lead Sponsor: Medacta International SA

Brief Summary

This is a post-marketing surveillance on Medacta Shoulder System

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• Status Verified: 2023-06
• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06
• Primary Completion: 2032-03
• Study Completion: 2037-03

Recruitment & Eligibility

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

Inclusion Criteria

• 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

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	10 years	Kaplan Meier method

Secondary Outcome Measures

Name	Time	Method
Adverse events	up to 10 years	record of adverse event
Clinical outcome evaluating Constant & Murley Score	1, 2, 5 and 10 years	Constant \& Murley Score (CMS): The CMS is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively
Radiographic performance of the implants evaluating presence of radiolucencies	3 months, 1, 2, 5 and 10 years	presence of radiolucencies
Functional outcome evaluating Oxford Shoulder Score	1, 2, 5 and 10 years	Oxford Shoulder Score (OSS): The Oxford Shoulder Score is a unidimensional score comprising 12 questions. Starting with 1 (best/fewest symptoms) to 5 (worst/most severe) which is awarded to correspond to the patient's symptoms. The total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability.
Patient evaluation quality of life	1, 2, 5 and 10 years	EQ-5D-5L: The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.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. Typically it is calculated by assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions)

Trial Locations

Locations (1)

Clinique Générale Annecy; 🇫🇷 Annecy, France