The Application of Personalized Titanium Plate in the Bone Tumors Around the Knee

Study Overview
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Brief Summary
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Microwave ablation of bone tumors is time-consuming and usually results in postoperative fractures. Hence the investigators designed and fabricated a titanium plate customized to the patient's bone structures for fixation after the removal of tumorous tissue, to improve the clinical outcomes of microwave ablation.

Detailed Description
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3D models of tumor-bearing bone segments were constructed by using computed tomography (CT) and magnetic resonance imaging (MRI). The 3D models were used to design the model of personalized titanium plates. The model of the plates was transferred into a numerical control machine for manufacturing the personalized titanium plates by 3D printing technology. The plates were then surgically implanted for reconstruction assistance following microwave-induced hyperthermia to remove the bone tumor. Implementation parameters and knee function were then evaluated.

Official Title
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Personalized Titanium Plate Improves Clinical Outcome in Microwave Ablation of Bone Tumors Around the Knee

Conditions
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Bone Tumors

Intervention / Treatment
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* Procedure: Personalized titanium plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of primary malignant bone tumors in the distal femur or proximal tibia according to the preoperative biopsy. Malignant soft tissue tumor invading distal femur or proximal tibia. The patients have the opportunity of limb salvage and treatment of microwave-induced hyperthermia in situ and reconstruction with internal fixation. Exclusion Criteria: Distant metastasis. Benign tumor. Metastatic tumor around the knee. No indication of limb salvage. Malignant soft tissue tumor without bone invasion. Recrudescent tumors.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized titanium plate<br>Ten males and two females with a mean age of 22.8 years were recruited. They all had bone tumor around the knee. | Procedure: Personalized titanium plate<br>* 3D models of tumor-bearing bone segments were constructed by using computed tomography (CT) and magnetic resonance imaging (MRI). The 3D models were used to design the model of personalized titanium plates. The model of the plates was transferred into a numerical control machine for manufacturing the personalized titanium plates by 3D printing technology. The plates were then surgically implanted for reconstruction assistance following microwave-induced hyperthermia to remove the bone tumor. Implementation parameters and knee function were then evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Musculoskeletal Tumor Society score |  | An average of 29 months | 
| Mean maximum flexion of the knee |  | An average of 29 months | 
| The six degrees of freedom of the gait | including flexion/extension, adduction/abduction, internal/external rotation, anteroposterior translation, distal/lateral translation, medial/lateral translation | An average of 29 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean operation time |  | Time when the operation was begun | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee, Titanium Plate