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

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ClinicalTrials.gov Identifier: NCT02901782
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : February 13, 2017
Sponsor:
Collaborators:
Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Yu Zhang, Guangzhou General Hospital of Guangzhou Military Command

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.

Condition or disease Intervention/treatment Phase
Bone Tumors Procedure: Personalized titanium plate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Titanium Plate Improves Clinical Outcome in Microwave Ablation of Bone Tumors Around the Knee
Study Start Date : January 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

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.




Primary Outcome Measures :
  1. Musculoskeletal Tumor Society score [ Time Frame: An average of 29 months ]
  2. Mean maximum flexion of the knee [ Time Frame: An average of 29 months ]
  3. The six degrees of freedom of the gait [ Time Frame: An average of 29 months ]
    including flexion/extension, adduction/abduction, internal/external rotation, anteroposterior translation, distal/lateral translation, medial/lateral translation


Secondary Outcome Measures :
  1. Mean operation time [ Time Frame: Time when the operation was begun ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901782


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

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Responsible Party: Yu Zhang, Principal Investigator, Clinical Professor, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02901782     History of Changes
Other Study ID Numbers: GuangzhouGH002
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yu Zhang, Guangzhou General Hospital of Guangzhou Military Command:
Knee
Titanium Plate

Additional relevant MeSH terms:
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Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases