DenCT Shoulder Bone Quality Evaluation

Launched by ZIMMER BIOMET · Sep 4, 2023

Keywords

ClinConnect Summary

The DenCT Shoulder Bone Quality Evaluation trial is designed to study how doctors can assess the quality of bone in the shoulder before performing surgery. This assessment will help create a scale that guides the use of a specific type of shoulder replacement surgery called stemless shoulder arthroplasty. The trial is not yet recruiting participants, but it aims to include adults aged 18 and older who are facing shoulder problems like osteoarthritis or rotator cuff tears and are considered suitable for shoulder replacement surgery.

To participate, individuals need to be able to undergo a CT scan, which is a type of imaging test that helps doctors see inside the body. Participants will need to provide consent to share their CT images with the study team. However, certain conditions, such as previous shoulder fractures or infections, may prevent someone from joining the study. Overall, this trial will help improve future shoulder surgeries by better understanding bone quality in patients.

Gender

ALL

Eligibility criteria

• 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.