TESS Shoulder Arthroplasty Data Collection

October 4, 2019 updated by: Zimmer Biomet

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

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

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Schilde, Belgium
        • De Dreef Van Zonnebos 13
  • France
      • Annecy, France
        • Clinique Générale
      • Berck, France, 59
        • Institut Calot
      • Bruges, France
        • Polyclinique Jean Villar
      • Chambery, France
        • Clinique St Joseph
      • Dax, France
        • Centre Hospitalier Général
      • Maxeville, France
        • Clinique Chirurgicale Orthopédique A.D.R.
      • Montpellier, France
        • Clinique St Jean
      • Paris, France
        • IRCOS
      • Pessac, France
        • Clinique St Martin
      • Saint Herblain, France
        • Polyclinique de l'Atlantique
      • St Etienne, France
        • Clinique Mutualiste
      • St Laurent du Var, France
        • Institut A. Tzanck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive series of patients received TESS prostheses

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TESS prosthesis
Consecutive series of patients with a TESS prosthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Constant Murley Score
Time Frame: 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.
6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
Change in Oxford Score
Time Frame: 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.
6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Collaborators

Biomet France SARL

Investigators

  • Principal Investigator: Laurent BEGUIN, MD, Clinique Mutualiste (Saint Etienne)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (Estimate)

September 12, 2008

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 4, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMETEU.CR.EU74

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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