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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02901782
Enrollment
12
Registered
2016-09-15
Start date
2013-01-31
Completion date
2016-08-31
Last updated
2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Tumors

Keywords

Knee, Titanium Plate

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.

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.

Sponsors

Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China
CollaboratorOTHER
The First Affiliated Hospital of Guangzhou Medical University
CollaboratorOTHER
Guangzhou General Hospital of Guangzhou Military Command
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 80 Years
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

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.

Design outcomes

Primary

MeasureTime frameDescription
The six degrees of freedom of the gaitAn average of 29 monthsincluding flexion/extension, adduction/abduction, internal/external rotation, anteroposterior translation, distal/lateral translation, medial/lateral translation
Musculoskeletal Tumor Society scoreAn average of 29 months
Mean maximum flexion of the kneeAn average of 29 months

Secondary

MeasureTime frame
Mean operation timeTime when the operation was begun

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026