S.E.S Shoulder Arthroplasty Data Collection

NCT ID: NCT00754416

Last Updated: 2017-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-03-31

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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S.E.S prosthesis

Consecutive series of patients with a S.E.S prosthesis.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomet France SARL

INDUSTRY

Sponsor Role collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent BEGUIN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier Bellevue

Locations

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De Dreef Van Zonnebos 13

Schilde, , Belgium

Site Status

Clinique Générale

Annecy, , France

Site Status

Clinique St Joseph

Chambéry, , France

Site Status

Centre Hospitalier Général

Dax, , France

Site Status

Clinique Chirurgicale Orthopédique A.D.R.

Maxéville, , France

Site Status

Clinique St Jean

Montpellier, , France

Site Status

IRCOS

Paris, , France

Site Status

Clinique St Martin

Pessac, , France

Site Status

Clinique Mutualiste

Saint-Etienne, , France

Site Status

Polyclinique de l'Atlantique

Saint-Herblain, , France

Site Status

Institut A. Tzanck

Saint-Laurent-du-Var, , France

Site Status

Institut Calot

Saint-Laurent-du-Var, , France

Site Status

Countries

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Belgium France

Other Identifiers

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BMET FR 02

Identifier Type: -

Identifier Source: org_study_id

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