Status:
NOT_YET_RECRUITING
DenCT Shoulder Bone Quality Evaluation
Lead Sponsor:
Zimmer Biomet
Collaborating Sponsors:
Zimmer, GmbH
Conditions:
Osteoarthritis Shoulder
Rotator Cuff Tears
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
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 cen...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06032416
Start Date
April 1 2025
End Date
April 1 2027
Last Update
February 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Joint Surgery, Sports Clinic Ishinomaki
Ishinomaki, Miyagi, Japan