Overview

This trial is active, not recruiting.

Condition arthritis
Sponsor Biomet, Inc.
Collaborator Biomet France SARL
Start date January 2006
End date October 2020
Trial size 600 participants
Trial identifier NCT00751673, BMETEU.CR.EU74

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Consecutive series of patients with a TESS prosthesis.

Primary Outcomes

Measure
Constance and oxford Scores
time frame: 6m, 1yr, 2yr, 3yr, 4yr, 5 yr, 7yr and 10yr

Secondary Outcomes

Measure
Complication
time frame: Any time
Patient Satisfaction
time frame: 6m,1yr,2yr,3yr,4yr, 5yr, 7yr and 10yr

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective, Multicentre Study Evaluating the Clinical Performance of the T.E.S.S Anatomic and Reverse Shoulder Prostheses
Principal investigator Laurent BEGUIN, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..