TESS Shoulder Arthroplasty Data Collection

This study is ongoing, but not recruiting participants.

First Received on September 11, 2008. Last Updated on December 5, 2011 History of Changes

Sponsor:	Biomet, Inc.
Collaborator:	Biomet France SARL
Information provided by (Responsible Party):	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00751673

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:	December 5, 2011
Health Authority:	France: French Data Protection Authority

ClinicalTrials.gov processed this record on February 12, 2012