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CompletedNCT02901782Updated Feb 13, 2017

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

An interventional study of Personalized titanium plate in Bone Tumors, sponsored by Guangzhou General Hospital of Guangzhou Military Command. Completed. Open to participants aged 5 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-13.

Sponsored by Guangzhou General Hospital of Guangzhou Military Command · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
5 Years to 80 Years
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Bone Tumors

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Keywords

  • Knee
  • Titanium Plate
03

In context

Bone Neoplasms

322 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.

This study's enrollment of 12 is below the median of 50 across 218 interventional studies indexed under Bone Neoplasms.

Browse Bone Neoplasms studies →

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command is the lead sponsor of 46 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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

Interventions

  • ProcedurePersonalized 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.

06

What researchers measure

Primary outcomes

  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

    including flexion/extension, adduction/abduction, internal/external rotation, anteroposterior translation, distal/lateral translation, medial/lateral translation

    Time frame: An average of 29 months

Secondary outcomes

  1. Mean operation time

    Time frame: Time when the operation was begun

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02901782
Lead 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
Responsible party
Yu Zhang (Principal Investigator, Clinical Professor, Guangzhou General Hospital of Guangzhou Military Command) — Principal investigator
First posted
Sep 15, 2016
Start date
Jan 2013
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Feb 13, 2017

Study contacts

Yu Zhang, PhD
study chair · Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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