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TESS Shoulder Arthroplasty Data Collection

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00751673
First Posted: September 12, 2008
Last Update Posted: March 13, 2017
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.
Collaborator:
Biomet France SARL
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
This observational study intends to collect efficacy and safety data on TESS 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 T.E.S.S Anatomic and Reverse Shoulder Prostheses

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Constance and oxford Scores [ Time Frame: 6m, 1yr, 2yr, 3yr, 4yr, 5 yr, 7yr and 10yr ]

Secondary Outcome Measures:
  • Complication [ Time Frame: Any time ]
  • Patient Satisfaction [ Time Frame: 6m,1yr,2yr,3yr,4yr, 5yr, 7yr and 10yr ]

Enrollment: 600
Study Start Date: January 2006
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
TESS prosthesis
Consecutive series of patients with a TESS prosthesis.

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.
  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
Belgium
De Dreef Van Zonnebos 13
Schilde, Belgium
France
Clinique Générale
Annecy, France
Institut Calot
Berck sur Mer, France
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
Principal Investigator: Laurent BEGUIN, MD Clinique Mutualiste (Saint Etienne)
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00751673     History of Changes
Other Study ID Numbers: BMETEU.CR.EU74
First Submitted: September 11, 2008
First Posted: September 12, 2008
Last Update Posted: March 13, 2017
Last Verified: July 2016