DenCT Shoulder Bone Quality Evaluation

Zimmer Biomet

Status

Not yet enrolling

Conditions

Osteoarthritis Shoulder

Rotator Cuff Tears

Treatments

Radiation: Preoperative CT Scan

Study type

Interventional

Funder types

Industry

Identifiers

NCT06032416

CSG2023-05E

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.