TESS Shoulder Arthroplasty Data Collection

This study is currently recruiting participants.

Verified by Biomet, Inc., December 2009

First Received: September 11, 2008 Last Updated: December 11, 2009 History of Changes

Sponsor:	Biomet, Inc.
Information provided by:	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:	Cohort, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2019
Estimated Primary Completion Date:	December 2019 (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

Contacts

Contact: Gregoire Edorh

+ 33 (0)4 75 75 91 19

gregoire.edorh@biomet.com

Locations

Belgium
De Dreef Van Zonnebos 13	Recruiting
Schilde, Belgium
Contact: Geert Declercq, MD
France
Clinique Mutualiste	Recruiting
St Etienne, France
Contact: Laurent BEGUIN, MD
Institut Calot	Recruiting
Berck Sur Mer, France
Contact: Denis BOUTTENS, MD
Institut A. Tzanck	Recruiting
St Laurent Du Var, France
Contact: Charles COHN, MD
IRCOS	Recruiting
Paris, France
Contact: Jean Grimberg, MD
Polyclinique de l'Atlantique	Recruiting
Saint Herblain, France
Contact: Dominique Huguet, MD
Polyclinique Jean Villar	Recruiting
Bruges, France
Contact: Frederic Liquois, MD
Clinique St Joseph	Recruiting
Chambery, France
Contact: Pierre Massart, MD
Clinique Chirurgicale Orthopédique A.D.R.	Recruiting
Maxeville, France
Contact: Bruno Rio, MD
Clinique St Jean	Recruiting
Montpellier, France
Contact: Jacques Teissier, MD
Clinique Générale	Recruiting
Annecy, France
Contact: Bruno Toussaint, MD
Centre Hospitalier Général	Recruiting
Dax, France
Contact: Bruno Zipoli, MD
Clinique St Martin	Recruiting
Pessac, France
Contact: Eric Lesprit, MD

Sponsors and Collaborators

Biomet, Inc.

Investigators

Principal Investigator:

Laurent BEGUIN, MD

Centre hospitalier Bellevue

More Information

No publications provided

Responsible Party:	Biomet France ( Gregoire Edorh, Clinical Manager )
Study ID Numbers:	BMET FR 01
Study First Received:	September 11, 2008
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00751673 History of Changes
Health Authority:	France: French Data Protection Authority

ClinicalTrials.gov processed this record on February 08, 2010