OsteoarthritisNCT01480440
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 5 sites in 2 countries.
Trial summary
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
- What is being tested?
- Trabecular Metal Reverse Shoulder System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2011to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Each investigator will screen from his/her patients who suffer from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ununited humeral head fracture, irreduciable 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff dificiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision) who meet the inclusion/exclusion criteria stated in the protocol
Who may be able to join
- Patient is > 18 years of age;
- Patient is skeletally mature;
- Patient qualifies for primary or revision unilateral or bilateral reverse total shoulder arthroplasty based on physical exam and medical history including the following: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ununited humeral head fracture, irreducible 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff deficiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision);
- Patient is willing and able to provide written informed consent;
- Patient is willing and able to cooperate in the required post-operative therapy;
- Patient is willing and able to complete scheduled follow-up evaluations/questionnaires as described in the Informed Consent;
- Patient has participated in the Informed Consent process and has signed the Institutional Review Board (IRB)/Ethical Review Board (ERB) approved informed consent.
Who cannot join
- The patient is a prisoner;
- The patient is mentally incompetent or unable to understand what participation in the study entails;
- The patient is a known alcohol or drug abuser;
- The patient is anticipated to be non-compliant;
- The patient has one of the following compromising the affected limb: a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable;
- The patient has a local/systemic infection;
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- The patient is known to be pregnant;
- The patient has marked bone loss;
- The patient has a known sensitivity or allergic reaction to one or more of the implanted materials;
- The patient is unwilling or unable to give consent or to comply with the follow-up program.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
The Rothman Institute
Egg Harbor, New Jersey, 08234
Norton Orthopaedic & Sports Medicine
Louisville, Kentucky, 40241
The Rothman Institute
Philadelphia, Pennsylvania, 19107
University of California, San Francisco
San Francisco, California, 94143
United Kingdom1 site
Royal Blackburn Hospital
Blackburn, Lancashire, BB2 3HH
About this study
Official title: Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Reverse Should System Used in Primary or Revision Reverse Total Shoulder Arthroplasty
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
Read the detailed description
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be collected and analyzed to monitor pain, function, and survivorship and to confirm the performance of the Trabecular Metal Reverse Shoulder System.
Performance will be evaluated by monitoring the frequency and incidence of adverse events as well as by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Trabecular metal Reverse Shoulder System.
Pain and functional performance will be measured using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE), survivorship will be based on removal or intended removal of the device, health status will be determined by evaluation of the Short Form Survey12 (SF-12) as well as Adverse Events (AEs) and radiographic parameters analysis of x-rays.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture, Irreducible 3-and 4-part Proximal Humeral Fractures, Avascular Necrosis
- Being tested
- Trabecular Metal Reverse Shoulder System
- Keywords
- Reverse Total Shoulder Arthroplasty (TSA), Reverse TSA, Osteoarthritis, Rheumatoid Arthritis, Post-traumatic arthritis, Ununited humeral head fracture, Irreducible 3-and 4-part proximal humeral fractures, Avascular necrosis, Gross rotator cuff deficiency, Failed total shoulder arthroplasty, Revision total shoulder arthroplasty
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabecular Metal Reverse Shoulder SystemDevice
Also called TM Reverse Shoulder System, TM Reverse System, TM Reverse
Trabecular Metal Reverse Shoulder System used in primary or revision total shoulder arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Trabecular Metal Reverse Shoulder System | Patients requiring primary or revision reverse total shoulder arthroplasty who receive the Trabecular Metal Reverse Shoulder System Receives: Device: Trabecular Metal Reverse Shoulder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Measured: 10 Years
Secondary outcomes (1)
Pain and Functional Performance
Measurements will be based on the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE)
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480440
- Sponsor's protocol ID
- CMU2010-28E
- Status last verified
- Apr 2026
- First submitted
- 23 Nov 2011
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Reverse Should System Used in Primary or Revision Reverse Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT01480440
- Acronym / sponsor ID
- CMU2010-28E
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture, Irreducible 3-and 4-part Proximal Humeral Fractures, Avascular Necrosis
- Keywords
- Reverse Total Shoulder Arthroplasty (TSA), Reverse TSA, Osteoarthritis, Rheumatoid Arthritis, Post-traumatic arthritis, Ununited humeral head fracture, Irreducible 3-and 4-part proximal humeral fractures, Avascular necrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Nov 2011 (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.
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
Detailed description
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be collected and analyzed to monitor pain, function, and survivorship and to confirm the performance of the Trabecular Metal Reverse Shoulder System.
Performance will be evaluated by monitoring the frequency and incidence of adverse events as well as by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Trabecular metal Reverse Shoulder System.
Pain and functional performance will be measured using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE), survivorship will be based on removal or intended removal of the device, health status will be determined by evaluation of the Short Form Survey12 (SF-12) as well as Adverse Events (AEs) and radiographic parameters analysis of x-rays.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trabecular Metal Reverse Shoulder System | – | Device: Trabecular Metal Reverse Shoulder SystemPatients requiring primary or revision reverse total shoulder arthroplasty who receive the Trabecular Metal Reverse Shoulder System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each investigator will screen from his/her patients who suffer from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ununited humeral head fracture, irreduciable 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff dificiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision) who meet the inclusion/exclusion criteria stated in the protocol
Key inclusion criteria (7 listed)
- Patient is > 18 years of age;
- Patient is skeletally mature;
- Patient qualifies for primary or revision unilateral or bilateral reverse total shoulder arthroplasty based on physical exam and medical history including the following: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ununited humeral head fracture, irreducible 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff deficiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision);
- Patient is willing and able to provide written informed consent;
- Patient is willing and able to cooperate in the required post-operative therapy;
Key exclusion criteria (10 listed)
- The patient is a prisoner;
- The patient is mentally incompetent or unable to understand what participation in the study entails;
- The patient is a known alcohol or drug abuser;
- The patient is anticipated to be non-compliant;
- The patient has one of the following compromising the affected limb: a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable;
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 |
|---|---|---|
| Trabecular Metal Reverse Shoulder SystemAlso: TM Reverse Shoulder System, TM Reverse System, TM ReverseTrabecular Metal Reverse Shoulder System used in primary or revision total shoulder arthroplasty | Device | Trabecular Metal Reverse Shoulder System |
Primary outcome
Survivorship
Time frame: 10 Years
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
1 secondary outcome
Pain and Functional Performance
Time frame: 10 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 and Rheumatoid Arthritis, run by Zimmer Biomet at 5 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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Survivorship (time frame: 10 Years). 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 28 Apr 2026.