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

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Tumors
• Intervention / Treatment: Procedure: Personalized titanium plate

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

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	Time Frame
Mean operation time	Time when the operation was begun

Collaborators and Investigators

• Sponsor: Guangzhou General Hospital of Guangzhou Military Command
• Collaborators: The First Affiliated Hospital of Guangzhou Medical University; Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China
• Investigators: Study Chair: Yu Zhang, PhD, Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Knee; Titanium Plate
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Bone Neoplasms
• Other Study ID Numbers: GuangzhouGH002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No