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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05926622
Other study ID # P06.001.03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date March 2037

Study information

Verified date June 2023
Source Medacta International SA
Contact Arianna Girardi
Phone +41 91 696 60 60
Email girardi@medacta.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a post-marketing surveillance on Medacta Shoulder System


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 2037
Est. primary completion date March 2032
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: 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


Locations

Country Name City State
France Clinique Générale Annecy Annecy

Sponsors (1)

Lead Sponsor Collaborator
Medacta International SA

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival Rate Kaplan Meier method 10 years
Secondary Clinical outcome evaluating Constant & Murley Score 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 1, 2, 5 and 10 years
Secondary Functional outcome evaluating Oxford Shoulder Score 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. 1, 2, 5 and 10 years
Secondary Radiographic performance of the implants evaluating presence of radiolucencies presence of radiolucencies 3 months, 1, 2, 5 and 10 years
Secondary Patient evaluation quality of life 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) 1, 2, 5 and 10 years
Secondary Adverse events record of adverse event up to 10 years
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