Shoulder PainNCT04003311
MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head
An observational study of Shoulder Pain and Shoulder Injuries, run by Zimmer Biomet at 4 sites in United States.
Trial summary
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and… 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 Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Head
- Type of treatment
- Medical device
- How many people
- 146 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Dec 2019to 29 Jul 2028
- 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: A consecutive series of subjects implanted with the Comprehensive Primary Micro Stem and/or the Comprehensive Anatomic Versa-Dial Titanium Humeral Heads in primary and/or revision total shoulder arthroplasty according to the approved indications.
Who may be able to join
- Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads
- Patient must be 18 years of age or older.
- Patient must have undergone a primary or revision shoulder arthroplasty with the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads for a cleared indication. Cleared indications include the following:
- non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- rheumatoid arthritis,
- revision where other devices or treatments have failed,
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- correction of functional deformity,
- fractures of the proximal humerus where other methods of treatment are deemed inadequate,
- difficult clinical management problems including cuff arthroplasty where other treatment methods may not be suitable or may be inadequate.
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
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- 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.
- Patient is a current alcohol or drug abuser.
- Patient is known to be pregnant or breastfeeding.
- Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Shoulder Clinic of Idaho
Boise, Idaho, 83704
Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont
Burlington, Vermont, 05405
University of Rochester
Rochester, New York, 14642
Beaumont Health
Royal Oak, Michigan, 48073
About this study
Official title: Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.
Read the detailed description
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,2,3,5,7 and 10 years*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.
The primary objective of this study 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 Disease, Shoulder Arthritis
- Being tested
- Comprehensive Primary Micro Stem, Comprehensive Anatomic Versa-Dial Titanium Humeral Head
- 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 Primary Micro StemDevice
Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.
Comprehensive Anatomic Versa-Dial Titanium Humeral HeadDevice
Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral head to repair shoulder malfunction/disease.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Primary Micro Stem | Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease. Receives: Device: Comprehensive Primary Micro Stem | |
| Comprehensive Anatomic Versa-Dial Titanium Humeral Heads | Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral Heads to repair shoulder malfunction/disease. Receives: Device: Comprehensive Anatomic Versa-Dial Titanium Humeral Head |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events
The primary objective of this study 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)
Device Performance and Benefits evaluated through the Oxford Shoulder Score outcome measure.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs), through the use of the Oxford Shoulder Score (OSS). The OSS is a 12 item questionnaire, each with 5 potential answers. Patients rate their symptoms from 1 (minimal symptoms) to 5 (severe symptoms). The combined total gives a minimum score of 12 and a maximum of 60. Higher scores in the OSS imply worse functionality.
Measured: Out to 10 years
Device Performance and Benefits 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), through the use of the Patient Assessment Questionnaire where adverse events and/or complications (yes or no), patient's activity level with regard to operative side, based on the UCLA Activity Score(wholly inactive 10, mostly inactive 9, sometimes participates in mild activities 8, regularly participates in mild activities 7, sometimes participates in moderate activities 6, regularly participates in moderate activities 5, regularly participates in active events 4, regularly participates in very active events 3, sometimes participates in impact sports 2, regularly participates in impact sports 1, or not recorded), and the Reported Score if Individual Scores are not available of the Oxford Shoulder Score. The UCLA Activity score rating is from 10 being the best outcome score, and 1 being the worst.
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 start13 Dec 2019
- Primary completion29 Jul 2028 (estimated)
- Study completion29 Jul 2028 (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
- 146 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
- NCT04003311
- Sponsor's protocol ID
- MDRG2017-89MS-46E
- Status last verified
- Oct 2025
- First submitted
- 18 Jun 2019
- Last updated
- 30 Oct 2025
- 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 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT04003311
- Acronym / sponsor ID
- MDRG2017-89MS-46E
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease, Shoulder Arthritis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 29 Jul 2028 (estimated)
- Study completion
- 29 Jul 2028 (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 enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.
Detailed description
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,2,3,5,7 and 10 years*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.
The primary objective of this study 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Primary Micro Stem | – | Device: Comprehensive Primary Micro StemPatients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease. |
| Comprehensive Anatomic Versa-Dial Titanium Humeral Heads | – | Device: Comprehensive Anatomic Versa-Dial Titanium Humeral HeadPatients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral Heads 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
- A consecutive series of subjects implanted with the Comprehensive Primary Micro Stem and/or the Comprehensive Anatomic Versa-Dial Titanium Humeral Heads in primary and/or revision total shoulder arthroplasty according to the approved indications.
Key inclusion criteria (9 listed)
- Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads
- Patient must be 18 years of age or older.
- Patient must have undergone a primary or revision shoulder arthroplasty with the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads for a cleared indication. Cleared indications include the following:
Key exclusion criteria (12 listed)
- Absolute contraindications include infection, sepsis, and osteomyelitis.
- Relative contraindications include:
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Patient is known to be pregnant or breastfeeding.
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 Primary Micro StemPatients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease. | Device | Comprehensive Primary Micro Stem |
| Comprehensive Anatomic Versa-Dial Titanium Humeral HeadPatients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral head to repair shoulder malfunction/disease. | Device | Comprehensive Anatomic Versa-Dial Titanium Humeral Heads |
Primary outcome
Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events
Time frame: Out to 10 years
The primary objective of this study 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
Device Performance and Benefits evaluated through the Oxford Shoulder Score outcome measure.
Time frame: Out to 10 years
Device Performance and Benefits 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 30 Oct 2025.
- 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
4 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 4 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 9 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 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Device Safety assessed through the frequency and incidence 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 30 Oct 2025.