Clinical trial NCT06032416: DenCT Shoulder Bone Quality Evaluation
Official title: Collection of CT Images to Evaluate Bone Quality Before Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis Shoulder
Rotator Cuff Tears
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Zimmer, GmbH
First posted: 2023-09-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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.

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.

Primary outcomes:
measure: CT scan data acquisition
timeFrame: Immediate post-op
measure: Intra-op bone quality evaluation: Thumb Test
timeFrame: Intra-op
measure: Intra-op bone quality evaluation: Pin Test
timeFrame: Intra-op
measure: Intra-op bone quality evaluation: Broach Test
timeFrame: Intra-op
measure: Duplicate CT scan data acquisition (Optional)
timeFrame: Immediate post-op
Secondary outcomes:
Other outcomes:
measure: Functional Performance (Optional): Constant & Murley Score
timeFrame: Pre-op
Locations:
city: Ishinomaki
country: Japan
facility: Joint Surgery, Sports Clinic Ishinomaki
state: Miyagi
Study officials:
affiliation: Zimmer, GmbH
name: Elliott Goff, PhD
role: STUDY_CHAIR
References: