TESS Shoulder Arthroplasty Data Collection - Full Text View

Sponsored by:	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

U.S. FDA Resources

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 and 5 yr ] [ 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 and 5yr ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	January 2006
Estimated Study Completion Date:	September 2016
Estimated Primary Completion Date:	September 2010 (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@biometeurope.com

Locations

France
Centre hospitalier Bellevue	Recruiting
St Etienne, France
Contact: Laurent BEGUIN, MD
Institut Calot	Recruiting
St Laurent du Var, France
Contact: Denis BOUTTENS, MD
Institut A. Tzanck	Recruiting
St Laurent du Var, France
Contact: Charles COHN, 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:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00751673
Health Authority:	France: French Data Protection Authority

ClinicalTrials.gov processed this record on February 12, 2009