DenCT Shoulder Bone Quality Evaluation

Sponsor
Zimmer Biomet
Study ID
NCT06032416
Status
Not Yet Recruiting

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Conditions

  • Osteoarthritis Shoulder
  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Preoperative CT Scan — RADIATION
    Preoperative CT Scan including a bone density calibration phantom. This data will be compared with surgeon intra-operative CRF responses.

Study Details

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.

Key Dates

First listed
Sep 13, 2023
Start date
Apr 30, 2025
Status verified
Feb 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Shoulder Arthroplasty
    Patients in need of a shoulder arthroplasty

Primary Outcome Measure

CT scan data acquisition [ Time Frame: Immediate post-op ]

Central Contacts

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