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

Guangzhou General Hospital of Guangzhou Military Command

Status: Completed

Conditions: Bone Tumors

Treatments: Procedure: Personalized titanium plate

Study type: Interventional

Funder types: Other

Identifiers

NCT02901782

GuangzhouGH002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 5 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Personalized titanium plate

Experimental group

Description:

Ten males and two females with a mean age of 22.8 years were recruited. They all had bone tumor around the knee.

Treatment:

Procedure: Personalized titanium plate