ArthritisNCT00751673
TESS Shoulder Arthroplasty Data Collection
An observational study of Arthritis, run by Zimmer Biomet at 13 sites in 2 countries.
Trial summary
This observational study intends to collect efficacy and safety data on TESS shoulder system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- How many people
- 600 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jan 2006to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive series of patients received TESS prostheses
Who may be able to join
- 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
Who cannot join
- Glenohumeral joint infection, osteomyelitis
- Neuro-muscular complications
- Inability to co-operate with and complete the study
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
France12 sites
Clinique Générale
Annecy
Institut Calot
Berck, 59
Polyclinique Jean Villar
Bruges
Clinique St Joseph
Chambéry
Centre Hospitalier Général
Dax
Clinique Chirurgicale Orthopédique A.D.R.
Maxéville
Clinique St Jean
Montpellier
IRCOS
Paris
Clinique St Martin
Pessac
Clinique Mutualiste
Saint-Etienne
Polyclinique de l'Atlantique
Saint-Herblain
Institut A. Tzanck
Saint-Laurent-du-Var
About this study
Official title: 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
Read the 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.
- Conditions
- Arthritis
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TESS prosthesis | Consecutive series of patients with a TESS prosthesis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
Secondary outcomes (2)
Complications
General and shoulder specific complicatons are collected any time.
Measured: Any time
Patient Satisfaction
Binary question.
Measured: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startJan 2006
- Primary completionOct 2019
- Study completionOct 2019
Why it stopped: No more data collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet France SARL
- Responsible party
- Sponsor
- Investigators
- Laurent BEGUIN, MD, Principal investigator, Clinique Mutualiste (Saint Etienne)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751673
- Sponsor's protocol ID
- BMETEU.CR.EU74
- Status last verified
- Oct 2019
- First submitted
- 11 Sep 2008
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre Study Evaluating the Clinical Performance of the T.E.S.S Anatomic and Reverse Shoulder Prostheses
- ClinicalTrials.gov ID
- NCT00751673
- Acronym / sponsor ID
- BMETEU.CR.EU74
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No more data collected.
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet France SARL
- Study start
- Jan 2006
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TESS prosthesis | – | –Consecutive series of patients with a TESS prosthesis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive series of patients received TESS prostheses
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Glenohumeral joint infection, osteomyelitis
- Neuro-muscular complications
- Inability to co-operate with and complete the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Complications
Time frame: Any time
Patient Satisfaction
Time frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
Results and safety
The study was stopped early (reason given: No more data collected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent BEGUIN, MD principal investigator
Clinique Mutualiste (Saint Etienne)
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Zimmer Biomet at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No more data collected.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Constant Murley Score (time frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.