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Active, not recruiting Observational

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

NCT07653178 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-06-01
Last updated
2026-06-30

Condition(s) studied

Bone NeoplasmsMusculoskeletal NeoplasmsBone Transplantation

Investigational drug(s) / intervention(s)

Hemielipsoid Formula-Based Preoperative and Intraoperative Bone Defect Volume Estimation

Hemielipsoid Formula-Based Preoperative and Intraoperative Bone Defect Volume Estimation: Preoperative bone defect volume is estimated by the operating surgeon using the hemielipsoid formula (V = 4/3 × π × a × b × c / 2) applied to routine preoperative CT imaging. The three principal dimensions of the anticipated resection defect are measured on axial, coronal, and sagittal CT reconstructions. Intraoperative defect volume is measured by saline cavity fill displacement as the reference standard. No additional procedures beyond standard surgical care are performed.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients diagnosed with a primary musculoskeletal tumor requiring surgical resection 2. Structural allograft reconstruction planned following resection 3. Routine preoperative CT imaging available for hemielipsoid measurements 4. Age ≥ 18 years 5. Written informed consent obtained Exclusion Criteria: 1. Metastatic bone tumors 2. Pathological fracture at the resection site precluding accurate volume estimation 3. Prior surgery at the same anatomical site 4. Unavailability of adequate preoperative CT imaging 5. Reconstruction planned with implant or autograft only (no structural allograft)

Primary outcome measure(s)

  • Agreement between preoperative hemielipsoid-estimated and intraoperative fluid displacement-measured bone defect volume — Intraoperative (Day 1)
    Assessed by Bland-Altman analysis and intraclass correlation coefficient (ICC) between the two volumetric measurement methods

Trial sites (1)

FacilityCityRegionStatus
Sakarya University Training and Research Hospital Sakarya Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07653178 on ClinicalTrials.gov ↗ ← All trials in Turkey