TESS Shoulder Arthroplasty Data Collection

Condition(s) targeted: Shoulder Replacement

Phase: N/A

Status: Recruiting

Sponsored by: Biomet, Inc.

Official(s) and/or principal investigator(s):
Laurent BEGUIN, MD, Principal Investigator, Affiliation: Centre hospitalier Bellevue

Overall contact:
Gregoire Edorh, Phone: + 33 (0)4 75 75 91 19, Email: gregoire.edorh@biomet.com

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

Official title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the T.E.S.S Anatomic and Reverse Shoulder Prostheses

Study design: Cohort, Prospective

Primary outcome: Constance and oxford Scores

Secondary outcome:

Complication

Patient Satisfaction

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Gregoire Edorh, Phone: + 33 (0)4 75 75 91 19, Email: gregoire.edorh@biomet.com

De Dreef Van Zonnebos 13, Schilde, Belgium; Recruiting
Geert Declercq, MD

Clinique Mutualiste, St Etienne, France; Recruiting
Laurent BEGUIN, MD

Institut Calot, Berck sur Mer, France; Recruiting
Denis BOUTTENS, MD

Institut A. Tzanck, St Laurent du Var, France; Recruiting
Charles COHN, MD

IRCOS, Paris, France; Recruiting
Jean Grimberg, MD

Polyclinique de l'Atlantique, Saint Herblain, France; Recruiting
Dominique Huguet, MD

Clinique St Martin, Pessac, France; Recruiting
Eric Lesprit, MD

Clinique St Joseph, Chambery, France; Recruiting
Pierre Massart, MD

Clinique Chirurgicale Orthopédique A.D.R., Maxeville, France; Recruiting
Bruno Rio, MD

Clinique St Jean, Montpellier, France; Recruiting
Jacques Teissier, MD

Clinique Générale, Annecy, France; Recruiting
Bruno Toussaint, MD

Centre Hospitalier Général, Dax, France; Recruiting
Bruno Zipoli, MD

Polyclinique Jean Villar, Bruges, France; Recruiting
Frederic Liquois, MD

Starting date: January 2006
Ending date: December 2019
Last updated: June 18, 2009