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S.E.S Shoulder Arthroplasty Data Collection

Sponsor
Zimmer Biomet (Industry)
Overall Status
Terminated
CT.gov ID
NCT00754416
Collaborator
Biomet France SARL (Industry)
100
Enrollment
12
Locations
162.1
Duration (Months)
8.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Mar 1, 2003
    Actual Primary Completion Date :
    Sep 1, 2016
    Actual Study Completion Date :
    Sep 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    S.E.S prosthesis

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

    Outcome Measures

    Primary Outcome Measures

    1. Constance and oxford Scores [6m, 1yr, 2yr, 3yr, 4yr and 5 yr]

    Secondary Outcome Measures

    1. Complication [Any time]

    2. Patient Satisfaction [6m,1yr,2yr,3yr,4yr and 5yr]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 De Dreef Van Zonnebos 13 Schilde Belgium
    2 Clinique Générale Annecy France
    3 Clinique St Joseph Chambery France
    4 Centre Hospitalier Général Dax France
    5 Clinique Chirurgicale Orthopédique A.D.R. Maxeville France
    6 Clinique St Jean Montpellier France
    7 IRCOS Paris France
    8 Clinique St Martin Pessac France
    9 Polyclinique de l'Atlantique Saint Herblain France
    10 Clinique Mutualiste St Etienne France
    11 Institut A. Tzanck St Laurent du Var France
    12 Institut Calot St Laurent du Var France

    Sponsors and Collaborators

    • Zimmer Biomet
    • Biomet France SARL

    Investigators

    • Principal Investigator: Laurent BEGUIN, MD, Centre hospitalier Bellevue

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zimmer Biomet
    ClinicalTrials.gov Identifier:
    NCT00754416
    Other Study ID Numbers:
    • BMET FR 02
    First Posted:
    Sep 18, 2008
    Last Update Posted:
    Mar 7, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by Zimmer Biomet
    Shoulder Replacement
    Additional relevant MeSH terms:
    Arthritis

    Study Results

    No Results Posted as of Mar 7, 2017