Clinical Trial

Predicting Allograft Volume in Orthopedic Oncology: Hemielipsoid Formula vs Intraoperative Fluid-Fill Measurement

Study acronym: PREDALL
Active, Not Recruiting
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Summary
Bone defects following primary musculoskeletal tumor resection are frequently reconstructed using structural allografts. Allograft availability is limited, and intraoperative waste due to oversized graft selection remains a practical challenge in orthopedic oncology. Accurate preoperative estimation of the expected defect volume is therefore critical not only for surgical planning but also for minimizing unnecessary allograft use. This prospective study aims to evaluate the accuracy of the preoperative hemielipsoid formula in estimating bone defect volume after primary musculoskeletal tumor resection, using intraoperative fluid displacement as the reference standard. A secondary aim is to determine whether preoperative CT-based hemielipsoid volume calculation can reliably guide allograft selection and reduce intraoperative graft waste. Patients scheduled for primary musculoskeletal tumor resection with structural allograft reconstruction at Sakarya University Training and Research Hospital will be enrolled. Preoperative defect volume will be estimated using the hemielipsoid formula (V = 4/3 × π × a × b × c / 2) derived from preoperative CT measurements. Intraoperative defect volume will be measured by fluid displacement as the reference standard. Agreement between methods will be assessed by Bland-Altman analysis and intraclass correlation coefficient (ICC).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-11.
Trial Details
NCT Number NCT07653178
Lead Sponsor Sakarya University
Conditions Bone Neoplasms, Musculoskeletal Neoplasms, Bone Transplantation
Enrollment 40 participants
Start Date 2026-06-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-30