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TESS 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.
 
ClinicalTrials.gov Identifier: NCT00751673
Recruitment Status : Terminated (No more data collected.)
First Posted : September 12, 2008
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Biomet France SARL
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease
Arthritis

Detailed Description:
The T.E.S.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 : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the T.E.S.S Anatomic and Reverse Shoulder Prostheses
Study Start Date : January 2006
Actual Primary Completion Date : October 2019
Actual Study Completion Date : October 2019

Group/Cohort
TESS prosthesis
Consecutive series of patients with a TESS prosthesis.



Primary Outcome Measures :
  1. Change in Constant Murley Score [ Time Frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year ]
    Improvement in this score will be collected at every follow-up visit.This is a 100-point score, containing 8 questions. Higher score indicate a better outcome.

  2. Change in Oxford Score [ Time Frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year ]
    Improvement in this score will be collected at every follow-up visit.This is a 60-point score, containing 12 questions. Higher score indicate a better outcome.


Secondary Outcome Measures :
  1. Complications [ Time Frame: Any time ]
    General and shoulder specific complicatons are collected any time.

  2. Patient Satisfaction [ Time Frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year ]
    Binary question.



Information from the National Library of Medicine

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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 TESS 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

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 ClinicalTrials.gov identifier (NCT number): NCT00751673


Locations
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Belgium
De Dreef Van Zonnebos 13
Schilde, Belgium
France
Clinique Générale
Annecy, France
Institut Calot
Berck, France, 59
Polyclinique Jean Villar
Bruges, 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
Sponsors and Collaborators
Zimmer Biomet
Biomet France SARL
Investigators
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Principal Investigator: Laurent BEGUIN, MD Clinique Mutualiste (Saint Etienne)
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00751673    
Other Study ID Numbers: BMETEU.CR.EU74
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases