OsteoarthritisNCT03423953
Comprehensive Nano - Post Market Clinical Follow-Up Study
An observational study of Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 5 sites in 4 countries.
Trial summary
This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- What is being tested?
- Comprehensive Nano
- Type of treatment
- Medical device
- How many people
- 194 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 30 Oct 2013to 31 Jul 2030
- 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
- Adult, Older adult
Study population: Patients in need of an uncemented shoulder arthroplasty and who meet all of the inclusion and none of the exclusion criteria.
Who may be able to join
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity.
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate
Who cannot join
- Infection
- Sepsis
- osteomyelitis
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
South Korea2 sites
Chonnam National University Hospital
Gwangju, Gwangju
Samsung Medical Centre
Seoul, Seoul, 06351
United Kingdom1 site
University of Liverpool
Liverpool, Merseyside, L69 3BX
About this study
Official title: Comprehensive Nano Post Market Data Collection
This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.
Read the detailed description
The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head.
This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Revision, Correction of Functional Deformity
- Being tested
- Comprehensive Nano
- Keywords
- osteoarthritis, avascular necrosis, rheumatoid arthritis
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive NanoDevice
Patients requiring the Comprehensive Nano shoulder system.
| Study group | Role | What they receive |
|---|---|---|
| Anatomic | Patients receiving the Anatomic or Hemi verison of the Comprehensive Nano. Receives: Device: Comprehensive Nano | |
| Reverse | Patients who have received the Reverse version of the Comprehensive Nano. Receives: Device: Comprehensive Nano |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
Kaplan Meier method
Measured: 10 years
Secondary outcomes (4)
ASES Score (American Shoulder and Elbow Surgeons)
Improvement in this score from preop to 10 year follow-up. This score includes 2 scales: 1 scale for pain, from 0 to 10 where 0 stands for "no pain at all" and 10 for "pain as bad as it can be". The second scale is for the stability of the shoulder, from 0 to 10 (0 stands for "very stable" and 10 for "very unstable").
Measured: 10 years
SANE Score (Single Assessment Numeric Evaluation)
Improvement in this score from preop to 10 year follow-up. This is a simple, single-question, patient-based shoulder function assessment tool: "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Measured: 10 years
Constant-Murley Score
Improvement in this score from preop to 10 year follow-up. This is a 100-point score. Higher scores indicate a better outcome.
Measured: 10 years
X-rays evaluated for radiolucencies, osteolysis, migration and subsidence
Standard evaluation performed on both humeral and glenoid components
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 posted6 Feb 2018
- Study start30 Oct 2013
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (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
- 194 participants (estimated)
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
- NCT03423953
- Sponsor's protocol ID
- ORTHO.CR.GE2.13
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2018
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Nano Post Market Data Collection
- ClinicalTrials.gov ID
- NCT03423953
- Acronym / sponsor ID
- ORTHO.CR.GE2.13
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Revision, Correction of Functional Deformity
- Keywords
- osteoarthritis, avascular necrosis, rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2013 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 6 Feb 2018 (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.
This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.
Detailed description
The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head.
This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomic | – | Device: Comprehensive NanoPatients receiving the Anatomic or Hemi verison of the Comprehensive Nano. |
| Reverse | – | Device: Comprehensive NanoPatients who have received the Reverse version of the Comprehensive Nano. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients in need of an uncemented shoulder arthroplasty and who meet all of the inclusion and none of the exclusion criteria.
Key inclusion criteria (6 listed)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity.
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate
Key exclusion criteria (3 listed)
- Infection
- Sepsis
- osteomyelitis
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 NanoPatients requiring the Comprehensive Nano shoulder system. | Device | Anatomic, Reverse |
Primary outcome
Survivorship
Time frame: 10 years
Kaplan Meier method
4 secondary outcomes
ASES Score (American Shoulder and Elbow Surgeons)
Time frame: 10 years
SANE Score (Single Assessment Numeric Evaluation)
Time frame: 10 years
Constant-Murley Score
Time frame: 10 years
X-rays evaluated for radiolucencies, osteolysis, migration and subsidence
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 21 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.
Paola Vivoda study director
Zimmer Biomet
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 5 sites in 4 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: under way, not looking for participants, as of the sponsor's last update on 21 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 South Korea, Austria, Canada, 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 21 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.