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S.E.S Shoulder Arthroplasty Data Collection

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Biomet France SARL
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00754416
First received: September 16, 2008
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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


Condition
Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the S.E.S Shoulder Prosthesis

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Constance and oxford Scores [ Time Frame: 6m, 1yr, 2yr, 3yr, 4yr and 5 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complication [ Time Frame: Any time ] [ Designated as safety issue: Yes ]
  • Patient Satisfaction [ Time Frame: 6m,1yr,2yr,3yr,4yr and 5yr ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2003
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
S.E.S prosthesis
Consecutive series of patients with a S.E.S prosthesis.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive series of patients received S.E.S prostheses

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754416

Locations
Belgium
De Dreef Van Zonnebos 13
Schilde, Belgium
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, France
Sponsors and Collaborators
Biomet, Inc.
Biomet France SARL
Investigators
Principal Investigator: Laurent BEGUIN, MD Centre hospitalier Bellevue
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00754416     History of Changes
Other Study ID Numbers: BMET FR 02
Study First Received: September 16, 2008
Last Updated: May 19, 2014
Health Authority: France: French Data Protection Authority

Keywords provided by Biomet, Inc.:
Shoulder Replacement

ClinicalTrials.gov processed this record on November 27, 2014