Osteoarthritis ShoulderNCT06032416
DenCT Shoulder Bone Quality Evaluation
A study testing Preoperative CT Scan in people with Osteoarthritis Shoulder and Rotator Cuff Tears, run by Zimmer Biomet at 1 site in Japan.
Trial summary
The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Shoulder, Rotator Cuff Tears
- What is being tested?
- Preoperative CT Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2025to Apr 2027
- Phase
- Interventional
- 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
Who may be able to join
- Patient must be older than 18 years and skeletally mature.
- Patient must undergo the SHA, TSA, or RSA according to the Instructions for Use (IFU).
- Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
- Patient is a candidate for lateral or bi-lateral shoulder arthroplasty due to one or more of the following:
- Non-inflammatory degenerative joint disease including osteoarthritis.
- Avascular necrosis of the humeral head.
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- Autoimmune disease including rheumatoid arthritis.
- Irreparable rotator cuff tears.
- Correction of functional deformity.
- Patient must be able and willing to sign the IRB/EC approved informed consent.
- Patient must be able to undergo a preoperative CT scan
- Patient must be willing to share their CT images with sponsor
Who cannot join
- Patient is a candidate for shoulder arthroplasty due to one or more of the following:
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- Revision TSA/RSA after the prior TSA/RSA.
- Patient has experienced the traumatic fractures to the implant site.
- Patient is unwilling or unable to give consent
- Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study, e.g., any neuromuscular disease compromising the affected limb.
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- Patient is known to be pregnant or breastfeeding.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non- compliant).
- Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.
- Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ghislain Maquer contact
Japan1 site
Joint Surgery, Sports Clinic Ishinomaki
Ishinomaki, Miyagi
Taku Hatta, PhD, +81-225-98-9901, t-hatta@jss-clinic.com
About this study
Official title: Collection of CT Images to Evaluate Bone Quality Before Total Shoulder Arthroplasty
The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.
Read the detailed description
The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality. Therefore, this study is not centered around a specific device and any primary shoulder arthroplasty system from Zimmer Biomet including anatomical, hemi, or reverse, stemmed or stemless configurations can be used for the target population. The indications of this study are the shoulder joint diseases such as osteoarthritis and the irreparable rotator cuff tears which are needed with TSA/RSA. The subjects should be also met the inclusion/exclusion criteria. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
- Conditions
- Osteoarthritis Shoulder, Rotator Cuff Tears
- Being tested
- Preoperative CT Scan
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative CT ScanRadiation
Preoperative CT Scan including a bone density calibration phantom. This data will be compared with surgeon intra-operative CRF responses.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Arthroplasty | Other | Patients in need of a shoulder arthroplasty Receives: Radiation: Preoperative CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT scan data acquisition
The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality.
Measured: Immediate post-op
Intra-op bone quality evaluation: Thumb Test
The first test is the Thumb test that occurs just after the head resection. The surgeon presses his/her thumb on the resected humeral surface to assess bone quality. If he can depress the thumb into the humerus without much resistance, then primary stability of the stemless implant may be insufficient.
Measured: Intra-op
Intra-op bone quality evaluation: Pin Test
The second test is the Pin test where the central pin used to position the trial head is wiggled to assess bone quality. If the central pin is unstable in the humerus, then this may indicate that the bone is soft/weak.
Measured: Intra-op
Intra-op bone quality evaluation: Broach Test
The third test is the Broach (or Puncher test) where the impactor is wiggled to assess bone quality. If the puncher is unstable after impaction, then the bone is soft/weak, and a stemmed prosthesis is recommended.
Measured: Intra-op
Duplicate CT scan data acquisition (Optional)
Additional primary endpoint for a sub-cohort of a maximum of 30 patients. These patients will receive a second preoperative CT scan after a changing position (patient repositioning), which is needed to evaluate the precision of the phantom-less method. This duplicated scan is considered optional in the study.
Measured: Immediate post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zimmer, GmbH
- Responsible party
- Sponsor
- Investigators
- Elliott Goff, PhD, Study chair, Zimmer, GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032416
- Sponsor's protocol ID
- CSG2023-05E
- Status last verified
- Feb 2025
- First submitted
- 4 Sep 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of CT Images to Evaluate Bone Quality Before Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT06032416
- Acronym / sponsor ID
- CSG2023-05E
- Conditions
- Osteoarthritis Shoulder, Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Zimmer, GmbH
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Sep 2023 (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 the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.
Detailed description
The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality. Therefore, this study is not centered around a specific device and any primary shoulder arthroplasty system from Zimmer Biomet including anatomical, hemi, or reverse, stemmed or stemless configurations can be used for the target population. The indications of this study are the shoulder joint diseases such as osteoarthritis and the irreparable rotator cuff tears which are needed with TSA/RSA. The subjects should be also met the inclusion/exclusion criteria. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder Arthroplasty | Other | Radiation: Preoperative CT ScanPatients in need of a shoulder arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient must be older than 18 years and skeletally mature.
- Patient must undergo the SHA, TSA, or RSA according to the Instructions for Use (IFU).
- Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
- Patient is a candidate for lateral or bi-lateral shoulder arthroplasty due to one or more of the following:
- Non-inflammatory degenerative joint disease including osteoarthritis.
Key exclusion criteria (11 listed)
- Patient is a candidate for shoulder arthroplasty due to one or more of the following:
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- Revision TSA/RSA after the prior TSA/RSA.
- Patient has experienced the traumatic fractures to the implant site.
- Patient is unwilling or unable to give consent
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 |
|---|---|---|
| Preoperative CT ScanPreoperative CT Scan including a bone density calibration phantom. This data will be compared with surgeon intra-operative CRF responses. | Radiation | Shoulder Arthroplasty |
Primary outcome
CT scan data acquisition
Time frame: Immediate post-op
The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality.
Intra-op bone quality evaluation: Thumb Test
Time frame: Intra-op
The first test is the Thumb test that occurs just after the head resection. The surgeon presses his/her thumb on the resected humeral surface to assess bone quality. If he can depress the thumb into the humerus without much resistance, then primary stability of the stemless implant may be insufficient.
Intra-op bone quality evaluation: Pin Test
Time frame: Intra-op
The second test is the Pin test where the central pin used to position the trial head is wiggled to assess bone quality. If the central pin is unstable in the humerus, then this may indicate that the bone is soft/weak.
Intra-op bone quality evaluation: Broach Test
Time frame: Intra-op
The third test is the Broach (or Puncher test) where the impactor is wiggled to assess bone quality. If the puncher is unstable after impaction, then the bone is soft/weak, and a stemmed prosthesis is recommended.
Duplicate CT scan data acquisition (Optional)
Time frame: Immediate post-op
Additional primary endpoint for a sub-cohort of a maximum of 30 patients. These patients will receive a second preoperative CT scan after a changing position (patient repositioning), which is needed to evaluate the precision of the phantom-less method. This duplicated scan is considered optional in the study.
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 10 Feb 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.
Ghislain Maquer contact
Elliott Goff, PhD study chair
Zimmer, GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative CT Scan in people with Osteoarthritis Shoulder and Rotator Cuff Tears, run by Zimmer Biomet at 1 site in Japan.
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 12 inclusion and 11 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: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Contact Elliott Goff, PhD (41792222308, elliott.goff@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT scan data acquisition (time frame: Immediate post-op). The study lists 5 primary outcomes in all. 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 10 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.