Study Stopped
No more data collected.
TESS Shoulder Arthroplasty Data Collection
A Prospective, Multicentre Study Evaluating the Clinical Performance of the T.E.S.S Anatomic and Reverse Shoulder Prostheses
1 other identifier
observational
600
2 countries
13
Brief Summary
This observational study intends to collect efficacy and safety data on TESS shoulder system
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2006
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 11, 2008
CompletedFirst Posted
Study publicly available on registry
September 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedOctober 8, 2019
October 1, 2019
13.8 years
September 11, 2008
October 4, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Complications
Any time
Patient Satisfaction
6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
Study Arms (1)
TESS prosthesis
Consecutive series of patients with a TESS prosthesis.
Eligibility Criteria
Consecutive series of patients received TESS prostheses
You may qualify if:
- 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
You may not qualify if:
- Glenohumeral joint infection, osteomyelitis
- Neuro-muscular complications
- Inability to co-operate with and complete the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
- Biomet France SARLcollaborator
Study Sites (13)
De Dreef Van Zonnebos 13
Schilde, Belgium
Clinique Générale
Annecy, France
Institut Calot
Berck, 59, France
Polyclinique Jean Villar
Bruges, France
Clinique St Joseph
Chambéry, France
Centre Hospitalier Général
Dax, France
Clinique Chirurgicale Orthopédique A.D.R.
Maxéville, France
Clinique St Jean
Montpellier, France
IRCOS
Paris, France
Clinique St Martin
Pessac, France
Clinique Mutualiste
Saint-Etienne, France
Polyclinique de l'Atlantique
Saint-Herblain, France
Institut A. Tzanck
Saint-Laurent-du-Var, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent BEGUIN, MD
Clinique Mutualiste (Saint Etienne)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2008
First Posted
September 12, 2008
Study Start
January 1, 2006
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
October 8, 2019
Record last verified: 2019-10