International Phase III Orthopedic Device Trial With 7,000 Imaging Examinations

Challenge

An international Phase III trial of a novel orthopedic device enrolled more than 400 patients and generated approximately 7,000 CT, MRI and radiographic examinations for the assessment of device safety and effectiveness. Orthopedic device endpoints combine quantitative measurements such as alignment, migration and implant position with qualitative assessments of bone response, loosening and adjacent-segment change, each requiring consistent technique across modalities and timepoints.

The sponsor needed a core lab able to manage a large multimodal volume, apply measurement conventions reproducibly across readers over the trial's duration, and manage metal artifact that degrades CT and MRI around implants.

Intrinsic Imaging’s Solution

Intrinsic Imaging developed the imaging charter with standardized radiographic positioning, CT metal artifact reduction parameters and MRI sequences suited to periprosthetic assessment, and qualified sites on test acquisitions. Image acquisition, transfer and quality control were centralized with acquisition feedback to sites.

Musculoskeletal radiologists performed quantitative measurements of implant position, migration and alignment and qualitative assessment of radiolucency, osteolysis, heterotopic ossification and adjacent-segment change under a reading charter with fixed landmarks and measurement methods. Primary endpoint assessments were double-read with adjudication.

Project management tracked roughly 7,000 examinations across the follow-up schedule, and reader agreement was monitored at planned intervals with recalibration as needed.

Intrinsic Imaging’s Results

• Approximately 7,000 CT, MRI and radiographic examinations from more than 400 patients processed and read across 26 sites in 9 countries
• Metal artifact reduction parameters standardized across CT and MRI, reducing unevaluable periprosthetic examinations to under 5%
• Quantitative implant measurements double-read on primary endpoints with reader agreement above 90%
• Qualitative safety findings including radiolucency, osteolysis and heterotopic ossification captured under predefined definitions at every timepoint