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S.E.S Shoulder Arthroplasty Data Collection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00754416
Recruitment Status : Terminated (Product no more sold)
First Posted : September 18, 2008
Last Update Posted : March 7, 2017
Biomet France SARL
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the S.E.S Shoulder Prosthesis
Study Start Date : March 2003
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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

Primary Outcome Measures :
  1. Constance and oxford Scores [ Time Frame: 6m, 1yr, 2yr, 3yr, 4yr and 5 yr ]

Secondary Outcome Measures :
  1. Complication [ Time Frame: Any time ]
  2. Patient Satisfaction [ Time Frame: 6m,1yr,2yr,3yr,4yr and 5yr ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive series of patients received S.E.S prostheses

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00754416

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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
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
Sponsors and Collaborators
Zimmer Biomet
Biomet France SARL
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Principal Investigator: Laurent BEGUIN, MD Centre hospitalier Bellevue
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Responsible Party: Zimmer Biomet Identifier: NCT00754416    
Other Study ID Numbers: BMET FR 02
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Keywords provided by Zimmer Biomet:
Shoulder Replacement
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases