Clinical and Radiological Outcomes of Medacta Shoulder System FR

Avascular Necrosis Clinical Trial

Official title:

Clinical and Radiological Outcomes of Medacta Shoulder System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926622
• Other study ID #: P06.001.03
• Status: Recruiting
• 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
• 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)

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

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