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

NCT02901782 | Completed

• 1 other identifier: GuangzhouGH002
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Tumors

Keywords

Knee; Titanium Plate

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Mean operation time

  Time when the operation was begun

Study Arms (1)

Personalized titanium plate

EXPERIMENTAL

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

Interventions

Personalized titanium plate PROCEDURE

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.

Personalized titanium plate

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Distant metastasis.
• Benign tumor.
• Metastatic tumor around the knee.
• No indication of limb salvage.
• Malignant soft tissue tumor without bone invasion.
• Recrudescent tumors.

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead
• Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Yu Zhang, PhD

  Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 15, 2016
• Study Start: January 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 13, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share