TESS Shoulder Arthroplasty Data Collection

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00751673
• Other study ID #: BMETEU.CR.EU74
• Status: Terminated
• Start date: January 2006
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 600
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis

Locations

Country	Name	City	State
Belgium	De Dreef Van Zonnebos 13	Schilde
France	Clinique Générale	Annecy
France	Institut Calot	Berck
France	Polyclinique Jean Villar	Bruges
France	Clinique St Joseph	Chambery
France	Centre Hospitalier Général	Dax
France	Clinique Chirurgicale Orthopédique A.D.R.	Maxeville
France	Clinique St Jean	Montpellier
France	IRCOS	Paris
France	Clinique St Martin	Pessac
France	Polyclinique de l'Atlantique	Saint Herblain
France	Clinique Mutualiste	St Etienne
France	Institut A. Tzanck	St Laurent du Var

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Biomet	Biomet France SARL

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Constant Murley Score	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.	6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
Primary	Change in Oxford Score	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.	6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
Secondary	Complications	General and shoulder specific complicatons are collected any time.	Any time
Secondary	Patient Satisfaction	Binary question.	6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year