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TESS 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:
NCT00751673
First received: September 11, 2008
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition
Shoulder Replacement

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 Biomet, Inc.:

Primary Outcome Measures:
  • Constance and oxford Scores [ Time Frame: 6m, 1yr, 2yr, 3yr, 4yr, 5 yr, 7yr and 10yr ] [ 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, 5yr, 7yr and 10yr ] [ Designated as safety issue: No ]

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
1
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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Biomet, Inc.
Biomet France SARL
Investigators
Principal Investigator: Laurent BEGUIN, MD Clinique Mutualiste (Saint Etienne)
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00751673     History of Changes
Other Study ID Numbers: EU74
Study First Received: September 11, 2008
Last Updated: July 12, 2012
Health Authority: France: French Data Protection Authority

ClinicalTrials.gov processed this record on May 22, 2013