TESS Shoulder Arthroplasty Data Collection

Terminated

• Conditions: Arthritis

• Registration Number: NCT00751673
• Lead Sponsor: Zimmer Biomet

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Status Verified: 2019-10
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Constant Murley Score	6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year	Improvement in this score will be collected at every follow-up visit.This is a 100-point score, containing 8 questions. Higher score indicate a better outcome.
Change in Oxford Score	6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year	Improvement in this score will be collected at every follow-up visit.This is a 60-point score, containing 12 questions. Higher score indicate a better outcome.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year	Binary question.
Complications	Any time	General and shoulder specific complicatons are collected any time.

Trial Locations

Locations (13)

De Dreef Van Zonnebos 13; 🇧🇪 Schilde, Belgium

Clinique Générale; 🇫🇷 Annecy, France

Institut Calot; 🇫🇷 Berck, France

Polyclinique Jean Villar; 🇫🇷 Bruges, France

Clinique St Joseph; 🇫🇷 Chambery, France

Polyclinique de l'Atlantique; 🇫🇷 Saint Herblain, France

IRCOS; 🇫🇷 Paris, France

Institut A. Tzanck; 🇫🇷 St Laurent du Var, France

Clinique Mutualiste; 🇫🇷 St Etienne, France

Centre Hospitalier Général; 🇫🇷 Dax, France

Clinique St Jean; 🇫🇷 Montpellier, France

Clinique Chirurgicale Orthopédique A.D.R.; 🇫🇷 Maxeville, France

Clinique St Martin; 🇫🇷 Pessac, France