Clinical and Radiological Outcomes of Medacta Shoulder System FR

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedacta International SA

About this trial

This is a post-marketing surveillance on Medacta Shoulder System

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients older than 18 years

Disqualifiers

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)

Trial population

Patients requiring TSA and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Survival Rate

Kaplan Meier method

Time frame
10 years

Secondary outcomes

1

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

Time frame
1, 2, 5 and 10 years
2

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.

Time frame
1, 2, 5 and 10 years
3

Radiographic performance of the implants evaluating presence of radiolucencies

presence of radiolucencies

Time frame
3 months, 1, 2, 5 and 10 years
4

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)

Time frame
1, 2, 5 and 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.