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

Primary Purpose

Bone Tumors

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personalized titanium plate
Sponsored by
Guangzhou General Hospital of Guangzhou Military Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Tumors focused on measuring Knee, Titanium Plate

Eligibility Criteria

5 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Personalized titanium plate

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Musculoskeletal Tumor Society score
    Mean maximum flexion of the knee
    The six degrees of freedom of the gait
    including flexion/extension, adduction/abduction, internal/external rotation, anteroposterior translation, distal/lateral translation, medial/lateral translation

    Secondary Outcome Measures

    Mean operation time

    Full Information

    First Posted
    August 31, 2016
    Last Updated
    February 9, 2017
    Sponsor
    Guangzhou General Hospital of Guangzhou Military Command
    Collaborators
    Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China, The First Affiliated Hospital of Guangzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02901782
    Brief Title
    The Application of Personalized Titanium Plate in the Bone Tumors Around the Knee
    Official Title
    Personalized Titanium Plate Improves Clinical Outcome in Microwave Ablation of Bone Tumors Around the Knee
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guangzhou General Hospital of Guangzhou Military Command
    Collaborators
    Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China, The First Affiliated Hospital of Guangzhou Medical University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Tumors
    Keywords
    Knee, Titanium Plate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Personalized titanium plate
    Arm Type
    Experimental
    Arm Description
    Ten males and two females with a mean age of 22.8 years were recruited. They all had bone tumor around the knee.
    Intervention Type
    Procedure
    Intervention Name(s)
    Personalized titanium plate
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Musculoskeletal Tumor Society score
    Time Frame
    An average of 29 months
    Title
    Mean maximum flexion of the knee
    Time Frame
    An average of 29 months
    Title
    The six degrees of freedom of the gait
    Description
    including flexion/extension, adduction/abduction, internal/external rotation, anteroposterior translation, distal/lateral translation, medial/lateral translation
    Time Frame
    An average of 29 months
    Secondary Outcome Measure Information:
    Title
    Mean operation time
    Time Frame
    Time when the operation was begun

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Distant metastasis. Benign tumor. Metastatic tumor around the knee. No indication of limb salvage. Malignant soft tissue tumor without bone invasion. Recrudescent tumors.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu Zhang, PhD
    Organizational Affiliation
    Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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