Osteoarthritis ShoulderNCT03431857
Multi Centre Study on TESS V2 Shoulder System
An observational study of Osteoarthritis Shoulder and Fracture, run by Zimmer Biomet at 2 sites in 2 countries.
Trial summary
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis
- What is being tested?
- TESS V2
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Oct 2010to 31 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients in need of Total Shoulder Arthroplasty (primary or revision) who receive the TESS V2 and who meet all of the inclusion and none of the exclusion criteria.
Who may be able to join
- Except in special cases, the "anatomic" type is indicated for:
- Centered osteoarthritis of the shoulder
- Humeral head fractures
- Rheumatoid arthritis (with intact rotator cuff)
- Avascular necrosis of the humeral head
- Except in special cases, the "reversed" type is indicated for:
Show all 19Show fewer
- Offset osteoarthritis of the shoulder
- Massive and non-repairable rotator cuff tears
- Rheumatoid arthritis (with degenerative rotator cuff)
- Revision in cases of:
- Replacement of an "anatomic" prosthesis with a "reversed" prosthesis
- Conversion of a hemi-arthroplasty into a total arthroplasty
- Increasing the size of the stem (length and/or diameter)
- Replacing a glenoid prosthesis
- Replacing a competitor's prosthesis
- In rare cases, removing a "reversed" prosthesis and replacing it with an "anatomic" prosthesis
- Additional inclusion criteria include
- Patient who read, understood study information and gave informed consent (oral or written depending on specific local regulatory requirements)
- Willing to return for follow-up evaluations
Who cannot join
- Local or systemic infections.
- Severe muscular, neurological, or vascular deficiency of the affected joint.
- Bone destruction or poor bone quality liable to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
- Cases where the corolla cannot be two-thirds covered with bone stock and including the stem/corolla junction.
- Any concomitant complaint likely to affect the functioning of the implant.
- Allergy to any of the implant components.
- Local bone tumors.
- Patient over 18 under law supervision
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Retrospective and Prospective, Multi Centre Study on T.E.S.S® V2 Shoulder System
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
Read the detailed description
The objective of this retrospective and prospective, multicenter, non-controlled Post Market Clinical Follow-up study is to evaluate the mid-term (5-year) clinical performance of the TESS Version 2 Anatomic and Reverse prostheses in shoulder arthroplasty. The primary outcome is defined as the clinical performance determined using Constant Score. The secondary outcomes are the passive and active mobility, the radiographic evaluation, the complications (including dislocation and revisions/removals) and survivorship.
- Conditions
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis, Rotator Cuff Tear, Revision
- Being tested
- TESS V2
- Keywords
- Shoulder arthroplasty, Medical device, Shoulder prosthesis, Performance
- Medical subject headings
- Fractures, Bone, Arthritis, Rheumatoid, Osteonecrosis, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TESS V2Device
Patients requiring the TESS V2 prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| TESS V2 Prosthesis | Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis. Receives: Device: TESS V2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Shoulder Score
The Constant Murley score is a multi-item scale assessing the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). The results are here reported as final score, which ranges from 0 to 100, with 0 representing the worst and 100 the best shoulder function.
Measured: Pre-operative, 5 years follow-up
Secondary outcomes (8)
Active Anterior Elevation
The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active anterior elevation measures the extent to which a patient can elevate the arm anteriorly and is here reported in degrees.
Measured: Pre-operative, 5 years follow-up
Active Lateral Elevation
The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active lateral elevation measures the extent to which a patient can elevate the arm laterally and is here reported in degrees.
Measured: Pre-operative, 5 years follow-up
Active External Rotation RE1
The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE1 measures the extent to which a patient can rotate the bent arm externally and is here reported in degrees.
Measured: Pre-operative, 5 years follow-up
Active External Rotation RE2
The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE2 measures the extent to which a patient can rotate the arm externally from a position of 90° of abduction and is here reported in degrees.
Measured: Pre-operative, 5 years follow-up
Passive Elevation
The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive elevation measures the extent to which the arm of the patient can be passively elevated in the plane of the scapula and is here reported in degrees.
Measured: Pre-operative, 5 years follow-up
Passive External Rotation
The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive external rotation elbow to body (RE 1) measures the extent to which the bent arm of the patient can be passively rotated externally and is here reported in degrees.
Measured: Pre-operative, 5 years follow-up
Radiographic Evaluation
A complete radiographic evaluation (front view 3 rotations, lateral view) is completed pre-operatively. For the post-operative radiographic evaluations, the form is simplified and contains two options: "unchanged" or "changed" when compared to the preoperative x-ray, with presence of radiolucencies and/or notching. The number of "changed" radiographic evaluations per time point are here reported.
Measured: Immediate post-operative, 6 weeks follow-up, 6 months follow-up, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up.
Survivorship
The Kaplan-Meier method is used to report implant survivorship. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 5 years post-operatively.
Measured: 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start20 Oct 2010
- Primary completion31 Dec 2015
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis ShoulderStudies 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
- Other
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paola Vivoda, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431857
- Sponsor's protocol ID
- ORTHO.CR.E13
- Status last verified
- Sep 2021
- First submitted
- 29 Jan 2018
- Last updated
- 19 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective, Multi Centre Study on T.E.S.S® V2 Shoulder System
- ClinicalTrials.gov ID
- NCT03431857
- Acronym / sponsor ID
- ORTHO.CR.E13
- Conditions
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis, Rotator Cuff Tear, Revision
- Keywords
- Shoulder arthroplasty, Medical device, Shoulder prosthesis, Performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2010 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Posted 19 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
Detailed description
The objective of this retrospective and prospective, multicenter, non-controlled Post Market Clinical Follow-up study is to evaluate the mid-term (5-year) clinical performance of the TESS Version 2 Anatomic and Reverse prostheses in shoulder arthroplasty. The primary outcome is defined as the clinical performance determined using Constant Score. The secondary outcomes are the passive and active mobility, the radiographic evaluation, the complications (including dislocation and revisions/removals) and survivorship.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TESS V2 Prosthesis | – | Device: TESS V2Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in need of Total Shoulder Arthroplasty (primary or revision) who receive the TESS V2 and who meet all of the inclusion and none of the exclusion criteria.
Key inclusion criteria (19 listed)
- Except in special cases, the "anatomic" type is indicated for:
- Except in special cases, the "reversed" type is indicated for:
- Revision in cases of:
- Additional inclusion criteria include
Key exclusion criteria (8 listed)
- Local or systemic infections.
- Severe muscular, neurological, or vascular deficiency of the affected joint.
- Bone destruction or poor bone quality liable to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
- Cases where the corolla cannot be two-thirds covered with bone stock and including the stem/corolla junction.
- Any concomitant complaint likely to affect the functioning of the implant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TESS V2Patients requiring the TESS V2 prosthesis. | Device | TESS V2 Prosthesis |
Primary outcome
Constant Shoulder Score
Time frame: Pre-operative, 5 years follow-up
The Constant Murley score is a multi-item scale assessing the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). The results are here reported as final score, which ranges from 0 to 100, with 0 representing the worst and 100 the best shoulder function.
8 secondary outcomes
Active Anterior Elevation
Time frame: Pre-operative, 5 years follow-up
Active Lateral Elevation
Time frame: Pre-operative, 5 years follow-up
Active External Rotation RE1
Time frame: Pre-operative, 5 years follow-up
Active External Rotation RE2
Time frame: Pre-operative, 5 years follow-up
Passive Elevation
Time frame: Pre-operative, 5 years follow-up
Passive External Rotation
Time frame: Pre-operative, 5 years follow-up
Radiographic Evaluation
Time frame: Immediate post-operative, 6 weeks follow-up, 6 months follow-up, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up.
Survivorship
Time frame: 5 years follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paola Vivoda study director
Zimmer Biomet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis Shoulder and Fracture, run by Zimmer Biomet at 2 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 19 inclusion and 8 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: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. 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?
Yes. Results are posted in the registry (first posted 19 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Constant Shoulder Score (time frame: Pre-operative, 5 years follow-up). 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 19 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.