Shoulder PainNCT04003272
MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere
An observational study of Shoulder Pain and Shoulder Injuries, run by Zimmer Biomet at 2 sites in United States.
Trial summary
The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7, and 10- year… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures
- What is being tested?
- Comprehensive Reverse Versa-Dial Titanium Glenosphere
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2019to 1 Sep 2035
- 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: Consecutive series of subjects implanted with the Comprehensive Versa-Dial Reverse Titanium (Ti) Glenosphere in primary, fracture and revision total shoulder arthroplasty according to the approved indications. Inclusion/exclusion criteria are identical to the indications and contraindications in the IFU.
Who may be able to join
- Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
- The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
- Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.
- Interlok™ finish humeral stems are intended for cemented use and the MacroBond™ coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
- For the specific components, Titanium (Ti) Glenospheres are intended for patients with Cobalt Alloy material sensitivity.
Who cannot join
- Absolute contraindications include infection, sepsis, and osteomyelitis.
- Relative contraindications include:
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Osteoporosis.
- Metabolic disorders which may impair bone formation.
- Osteomalacia.
Show all 12Show fewer
- Distant foci of infections which may spread to the implant site.
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
- Patient is a prisoner.
- Current alcohol or drug abuser.
- If female, patient is known to be pregnant or breastfeeding.
- Patient has a psychiatric illness or cognitive deficit that will not allow from proper informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Buffalo
Buffalo, New York, 14215
Norton Orthopaedic and Sports Medicine
Louisville, Kentucky, 40241
About this study
Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Versa-Dial Reverse Titanium (Ti) Glenosphere in Primary, Fracture and Revision Total Shoulder Arthroplasty
The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7, and 10- year follow-up* to meet EU Medical Device and other Regulatory Requirements for Post-Market Surveillance. Because Comprehensive Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well to collect long-term data.
*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.
Read the detailed description
The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7, and 10- year follow-up* to meet EU Medical Device and other Regulatory Requirements for Post-Market Surveillance. Because Comprehensive Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well to collect long-term data.
The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to either implant or instrumentation should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).
*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Arthritis, Shoulder Disease
- Being tested
- Comprehensive Reverse Versa-Dial Titanium Glenosphere
- Medical subject headings
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Reverse Versa-Dial Titanium GlenosphereDevice
Implant used for patients with allergy to typical device material metals to repair shoulder malfunction/disease.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Reverse Versa-Dial Titanium Glenosphere | Patients who have an allergy to typical cobalt chrome or other metal allergies had surgery to repair shoulder malfunction/disease. Receives: Device: Comprehensive Reverse Versa-Dial Titanium Glenosphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Safety assessed through the incidence and frequency of revisions, complications and adverse events
The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to either implant or instrumentation should be specified.
Measured: Out to 10 years
Secondary outcomes (2)
Product Clinical Benefits and Performance evaluated through the Oxford Shoulder Scale OSS or Oxford Shoulder Questionnaire.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) using the Oxford Shoulder Scale or Oxford Shoulder Questionnaire. The Scale ranges from 0-48 with 48 indicating a satisfactory joint function score. A score of 30-39 indicated moderate to mild arthritis, a score of 20-29 indicates moderate to severe arthritis and a score of 0-19 indicates severe arthritis.
Measured: Out to10 years
Product Clinical Benefits and Performance evaluated through the Patient Assessment Questionnaire
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs). This will be accomplished through the use of the Patient Assessment Questionnaire where adverse events and/or complications (yes or no- if yes, an Adverse Event Report would be completed), patient's activity level with regard to operative side (wholly inactive, mostly inactive, sometimes participates in mild activities, regularly participates in mild activities, sometimes participates in moderate activities, regularly participates in moderate activities, regularly participates in active events, regularly participates in very active events, sometimes participates in impact sports, regularly participates in impact sports, or not recorded), and the Reported Score if Individual Scores are not available. (This would be the reported score of the Oxford Shoulder Scale as described above in Outcome 2).
Measured: Out to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start28 Oct 2019
- Primary completion19 Aug 2034 (estimated)
- Study completion1 Sep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Osborn, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003272
- Sponsor's protocol ID
- MDRG2017-89MS-40E
- Status last verified
- Feb 2026
- First submitted
- 18 Jun 2019
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Versa-Dial Reverse Titanium (Ti) Glenosphere in Primary, Fracture and Revision Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT04003272
- Acronym / sponsor ID
- MDRG2017-89MS-40E
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Arthritis, Shoulder Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 19 Aug 2034 (estimated)
- Study completion
- 1 Sep 2035 (estimated)
- First posted
- 1 Jul 2019 (actual)
- 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 objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7, and 10- year follow-up* to meet EU Medical Device and other Regulatory Requirements for Post-Market Surveillance. Because Comprehensive Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well to collect long-term data.
*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.
Detailed description
The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7, and 10- year follow-up* to meet EU Medical Device and other Regulatory Requirements for Post-Market Surveillance. Because Comprehensive Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well to collect long-term data.
The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to either implant or instrumentation should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).
*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Reverse Versa-Dial Titanium Glenosphere | – | Device: Comprehensive Reverse Versa-Dial Titanium GlenospherePatients who have an allergy to typical cobalt chrome or other metal allergies had surgery to repair shoulder malfunction/disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive series of subjects implanted with the Comprehensive Versa-Dial Reverse Titanium (Ti) Glenosphere in primary, fracture and revision total shoulder arthroplasty according to the approved indications. Inclusion/exclusion criteria are identical to the indications and contraindications in the IFU.
Key inclusion criteria (5 listed)
- Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
- The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
- Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.
- Interlok™ finish humeral stems are intended for cemented use and the MacroBond™ coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
- For the specific components, Titanium (Ti) Glenospheres are intended for patients with Cobalt Alloy material sensitivity.
Key exclusion criteria (12 listed)
- Absolute contraindications include infection, sepsis, and osteomyelitis.
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Osteoporosis.
- Metabolic disorders which may impair bone formation.
- Osteomalacia.
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 |
|---|---|---|
| Comprehensive Reverse Versa-Dial Titanium GlenosphereImplant used for patients with allergy to typical device material metals to repair shoulder malfunction/disease. | Device | Comprehensive Reverse Versa-Dial Titanium Glenosphere |
Primary outcome
Product Safety assessed through the incidence and frequency of revisions, complications and adverse events
Time frame: Out to 10 years
The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to either implant or instrumentation should be specified.
2 secondary outcomes
Product Clinical Benefits and Performance evaluated through the Oxford Shoulder Scale OSS or Oxford Shoulder Questionnaire.
Time frame: Out to10 years
Product Clinical Benefits and Performance evaluated through the Patient Assessment Questionnaire
Time frame: Out to 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 6 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Erin Osborn study director
Zimmer Biomet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Shoulder Injuries, run by Zimmer Biomet at 2 sites in United States.
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 5 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 6 Feb 2026. 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 United States. 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?
Product Safety assessed through the incidence and frequency of revisions, complications and adverse events (time frame: Out to 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 6 Feb 2026.