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

Not Applicable

Completed

• Conditions: Bone Tumors
• Interventions: Procedure: Personalized titanium plate

• Registration Number: NCT02901782
• Lead Sponsor: Guangzhou General Hospital of Guangzhou Military Command

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Clinical diagnosis of primary malignant bone tumors in the distal femur or proximal tibia according to the preoperative biopsy.
2. Malignant soft tissue tumor invading distal femur or proximal tibia.
3. The patients have the opportunity of limb salvage and treatment of microwave-induced hyperthermia in situ and reconstruction with internal fixation.

Exclusion Criteria

1. Distant metastasis.
2. Benign tumor.
3. Metastatic tumor around the knee.
4. No indication of limb salvage.
5. Malignant soft tissue tumor without bone invasion.
6. Recrudescent tumors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized titanium plate	Personalized titanium plate	Ten males and two females with a mean age of 22.8 years were recruited. They all had bone tumor around the knee.

Primary Outcome Measures

Name	Time	Method
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	An average of 29 months	including flexion/extension, adduction/abduction, internal/external rotation, anteroposterior translation, distal/lateral translation, medial/lateral translation

Secondary Outcome Measures

Name	Time	Method
Mean operation time	Time when the operation was begun