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S.E.S Shoulder Arthroplasty Data Collection

Information source: Biomet, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis

Phase: N/A

Status: Terminated

Sponsored by: Biomet, Inc.

Official(s) and/or principal investigator(s):
Laurent BEGUIN, MD, Principal Investigator, Affiliation: Centre hospitalier Bellevue

Summary

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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Constance and oxford Scores

Secondary outcome:

Complication

Patient Satisfaction

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

De Dreef Van Zonnebos 13, Schilde, Belgium

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, France

Additional Information

Starting date: March 2003
Last updated: June 4, 2015

Page last updated: August 20, 2015

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