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Completed

NCT Number: NCT02901782

The Application of Personalized Titanium Plate in the 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.

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Key information

Conditions

Bone Tumors Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site

Age range

5 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

    Time frame: An average of 29 months

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

Secondary outcomes

  1. Mean operation time

    Time frame: Time when the operation was begun

Sponsors and collaborators

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command

Other

Collaborators

  • Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China
  • The First Affiliated Hospital of Guangzhou Medical University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2016
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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