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NCT00754416 Clinical Trial

S.E.S Shoulder Arthroplasty Data Collection

Arthritis Clinical Trial

Official title:
A Prospective, Multicentre Study Evaluating the Clinical Performance of the S.E.S Shoulder Prosthesis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00754416
Other study ID # BMET FR 02
Secondary ID
Status Terminated
Phase N/A
First received September 16, 2008
Last updated March 6, 2017
Start date March 2003
Est. completion date September 2016

Study information
Verified date March 2017
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational study intends to collect efficacy and safety data on S.E.S shoulder system

Description:

The S.E.S.® shoulder system has been developed to provide a complete solution for all the indications for Shoulder Arthroplasty, Arthritis, Rotator Cuff Arthropathy, Proximal Humeral Fracture, minimising bone resection and restoring the natural anatomy of the patient.

Recruitment information / eligibility
Status Terminated
Enrollment 100
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- A pre-operative level of pain and function the same as for conventional joint replacement

- A likelihood of obtaining relief of pain and improved function

- Full skeletal maturity

- Ability to follow instructions

- Good general health for age

- Willing to return for follow-up evaluations

Exclusion Criteria:

- Glenohumeral joint infection, osteomyelitis

- Neuro-muscular complications

- Inability to co-operate with and complete the study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium De Dreef Van Zonnebos 13 Schilde
France Clinique Générale Annecy
France Clinique St Joseph Chambery
France Centre Hospitalier Général Dax
France Clinique Chirurgicale Orthopédique A.D.R. Maxeville
France Clinique St Jean Montpellier
France IRCOS Paris
France Clinique St Martin Pessac
France Polyclinique de l'Atlantique Saint Herblain
France Clinique Mutualiste St Etienne
France Institut A. Tzanck St Laurent du Var
France Institut Calot St Laurent du Var

Sponsors (2)
Lead Sponsor Collaborator
Zimmer Biomet Biomet France SARL

Countries where clinical trial is conducted

Belgium,  France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Constance and oxford Scores 6m, 1yr, 2yr, 3yr, 4yr and 5 yr
Secondary Complication Any time
Secondary Patient Satisfaction 6m,1yr,2yr,3yr,4yr and 5yr
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