Status:
NOT_YET_RECRUITING
A Prospective Study of the Safety and Efficacy of 3D-printed Non-rigid Biomimetic Implant in Cervical and Thoracolumbar Spine
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Spinal Tumor
Eligibility:
All Genders
20-79 years
Phase:
NA
Brief Summary
Vertebral body resection is a wide accepted procedure in tumor resection, deformity correction, and anterior decompression in spondylosis, ossification of posterior longitudinal ligaments, and spondyl...
Detailed Description
This is a single-arm prospective observational phase I clinical study to investigate the safety of the non-rigid 3D printed custom-made biomimetic implant. The implants are made of Titanium alloy. Pat...
Eligibility Criteria
Inclusion
- Age 20 - 79 years;
- Patient meet the indication for 1- to 3- level corpectomy, for primary bone tumor at spine, or metastatic tumor at spine.
- Deficit confirmed by CT, MRI, and X-ray;
- Pathology level located from C3 to L5.
- Physically and mentally able and willing to comply with the protocol;
- Signed informed consent;
- NTU Spine Multidisciplinary Board confirmed tumor excision surgery is indicated.
- Life expectancy longer than 6 months (Tokuhashi Scoring System)
Exclusion
- Patient does not meet the indication of corpectomy, which is under the surveillance.
- More than three vertebrae required corpectomy;
- Corpectomy levels above C3 and below L5
- T-score less than -2.5
- Known allergy to device materials - such as titanium
- Any diseases or conditions that would preclude accurate clinical evaluation;
- Daily, high-dose oral and/or inhaled steroid or a history of chronic use of high dose steroids;
- BMI \> 35
- Life expectancy less than 6 months - (Tokuhashi Scoring System)
- The subject has received radiation therapy or chemotherapy at the trial site within one year;
- Anterior spine surgery has been received at or near the spine surgery site;
- The subject has systemic infection,or focal vertebral infection or trauma;
- The subject has endocrine disorders or metabolic disorders known to affect bone formation, such as: Paget's disease, renal osteodystrophy, hypothyroidism;
- The subject has neuromuscular diseases, those at risk of instability, implant fixation failure or postoperative care complications, including: spina bifida, cerebral palsy, and multiple sclerosis;
- Osteopenia, osteomyelitis;
- Pregnant women.
Key Trial Info
Start Date :
January 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05396222
Start Date
January 1 2027
End Date
January 1 2028
Last Update
December 17 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan