Clinical trial · Observational
Predicting Allograft Volume in Orthopedic Oncology: Hemielipsoid Formula vs Intraoperative Fluid-Fill Measurement
Preoperative Bone Defect Volume Estimation Using the Hemielipsoid Formula for Allograft Planning in Musculoskeletal Tumor Surgery: A Prospective Validation Study Against Intraoperative Fluid Displacement Measurement
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Neoplasms | Bone Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Bone Transplantation | — | UNRESOLVED | — |
| Musculoskeletal Neoplasms | Musculoskeletal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemielipsoid Formula-Based Preoperative and Intraoperative Bone Defect Volume Estimation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Hemielipsoid Volume Estimation Group
- description
- atients undergoing primary musculoskeletal tumor resection with structural allograft reconstruction. Preoperative bone defect volume is estimated using the hemielipsoid formula from CT imaging. Intraoperative defect volume is measured by saline cavity fill displacement as the reference standard.
- interventionNames
- Procedure: Hemielipsoid Formula-Based Preoperative and Intraoperative Bone Defect Volume Estimation
Primary outcomes (1)
- measure
- Agreement between preoperative hemielipsoid-estimated and intraoperative fluid displacement-measured bone defect volume
- timeFrame
- Intraoperative (Day 1)
- description
- Assessed by Bland-Altman analysis and intraclass correlation coefficient (ICC) between the two volumetric measurement methods
Secondary outcomes (1)
- measure
- Allograft waste volume
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
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