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

Bone Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901782
• Other study ID #: GuangzhouGH002
• Status: Completed
• Phase: N/A
• First received: August 31, 2016
• Last updated: February 9, 2017
• Start date: January 2013
• Est. completion date: August 2016

Study information

• Verified date: February 2017
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Neoplasms
• Bone Tumors

Intervention

Procedure:
• Personalized titanium plate
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command	Guangdong Key Laboratory of Orthopaedic Technology and Implant Material, Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Musculoskeletal Tumor Society score		An average of 29 months
Primary	Mean maximum flexion of the knee		An average of 29 months
Primary	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	Mean operation time		Time when the operation was begun