A Prospective Study of the Safety and Efficacy of 3D-printed Non-rigid Biomimetic Implant in Cervical and Thoracolumbar Spine

NCT05396222 | Not Yet Recruiting

• 1 other identifier: 202202015DIPC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 spondylodiscitis surgery. However, reconstruction of segmental defect is still challenging to spine surgeon, especially in 3-column resection, such as total en bloc spondylectomy in tumor patients. Various graft or prosthesis for reconstruction has been reported, such as structural allograft, Harms mesh cages, expandable cages, and carbon fiber stackable cages. There are no high evidence level study examining the superiority of those different methods. Recently, 3D printed vertebral body replacement has been reported in different disease entities as well, such as tumor, Kümmell's disease in osteoporosis, and spondylosis. 3D printed implant comes with superiority in production of complex geometries and regularity of the fine surface detailed that promote bone ingrowth. Although, 3D-printed titanium vertebra could achieved bone integration in human, a systemic review showed that the subsidence noted in 31.4% of spine surgery with 3D printed implants. In spine surgery, the fixation construct is sufficiently stiff, interbody motion can be reduced, and loading sharing promotes bone fusion. On the other hand, if the reconstruction is too stiff, stress shielding at fusion site occurs. The concept of dynamic fusion, as opposed to rigid fusion, has been demonstrated by an anterior cervical interbody fusion study in porcine model, demonstrating good bone formation, less postfusion stiffness, and a trend to less subsidence. Thus, we developed a 3D printed, custom-made, biomimetic prosthesis, with non-rigid structure, which has been tested in biomechanical study and porcine model, showing good bone formation and less stiffness as well. Therefore, we proposed a prospective clinical study to investigate safety, subsidence, and fusion of this prosthesis.

Conditions

Spinal Tumor

Keywords

Spinal Tumor; Reconstruction

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  We will follow up the condition of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  Patient were evaluated at 12 months postoperatively.

Secondary Outcomes (8)

• Degree of change in the subsidence

  Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.

• The percentage of patients with successful fusion

  Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.

• Pain score

  Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.

• Short form-12 mental component score

  Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.

• Anxiety score

  Patient were evaluated pre-operatively, immediately after the surgery, and 1, 3, 6, 12 months postoperatively.

Study Arms (1)

3D-printed

EXPERIMENTAL

We developed a 3D printed, custom-made, biomimetic prosthesis, with non-rigid structure, which has been tested in biomechanical study and porcine model, showing good bone formation and less stiffness as well. Therefore, we proposed a prospective clinical study to investigate safety, subsidence, and fusion of this prosthesis.

Device: 3D-printed custom-made non-rigid biomimetic implant

Interventions

3D-printed custom-made non-rigid biomimetic implant DEVICE

We developed a 3D printed, custom-made, biomimetic prosthesis, with non-rigid structure, which has been tested in biomechanical study and porcine model, showing good bone formation and less stiffness as well. Therefore, we proposed a prospective clinical study to investigate safety, subsidence, and fusion of this prosthesis.

3D-printed

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (17)

• Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K. Anterior fresh frozen structural allografts in the thoracic and lumbar spine. Do they work if combined with posterior fusion and instrumentation in adult patients with kyphosis or anterior column defects? Spine (Phila Pa 1976). 1995 Jun 15;20(12):1410-8.

  PMID: 7676341 RESULT

• Lewandrowski KU, Hecht AC, DeLaney TF, Chapman PA, Hornicek FJ, Pedlow FX. Anterior spinal arthrodesis with structural cortical allografts and instrumentation for spine tumor surgery. Spine (Phila Pa 1976). 2004 May 15;29(10):1150-8; discussion 1159. doi: 10.1097/00007632-200405150-00019.

  PMID: 15131446 RESULT

• Dvorak MF, Kwon BK, Fisher CG, Eiserloh HL 3rd, Boyd M, Wing PC. Effectiveness of titanium mesh cylindrical cages in anterior column reconstruction after thoracic and lumbar vertebral body resection. Spine (Phila Pa 1976). 2003 May 1;28(9):902-8. doi: 10.1097/01.BRS.0000058712.88053.13.

  PMID: 12942006 RESULT

• Viswanathan A, Abd-El-Barr MM, Doppenberg E, Suki D, Gokaslan Z, Mendel E, Rao G, Rhines LD. Initial experience with the use of an expandable titanium cage as a vertebral body replacement in patients with tumors of the spinal column: a report of 95 patients. Eur Spine J. 2012 Jan;21(1):84-92. doi: 10.1007/s00586-011-1882-7. Epub 2011 Jun 18.

  PMID: 21681631 RESULT

• Boriani S, Biagini R, Bandiera S, Gasbarrini A, De Iure F. Reconstruction of the anterior column of the thoracic and lumbar spine with a carbon fiber stackable cage system. Orthopedics. 2002 Jan;25(1):37-42. doi: 10.3928/0147-7447-20020101-14.

  PMID: 11811240 RESULT

• Xu N, Wei F, Liu X, Jiang L, Cai H, Li Z, Yu M, Wu F, Liu Z. Reconstruction of the Upper Cervical Spine Using a Personalized 3D-Printed Vertebral Body in an Adolescent With Ewing Sarcoma. Spine (Phila Pa 1976). 2016 Jan;41(1):E50-4. doi: 10.1097/BRS.0000000000001179.

  PMID: 26335676 RESULT

• Glennie RA, Rampersaud YR, Boriani S, Reynolds JJ, Williams R, Gokaslan ZL, Schmidt MH, Varga PP, Fisher CG. A Systematic Review With Consensus Expert Opinion of Best Reconstructive Techniques After Osseous En Bloc Spinal Column Tumor Resection. Spine (Phila Pa 1976). 2016 Oct 15;41 Suppl 20:S205-S211. doi: 10.1097/BRS.0000000000001835.

  PMID: 27488296 RESULT

• Choy WJ, Mobbs RJ, Wilcox B, Phan S, Phan K, Sutterlin CE 3rd. Reconstruction of Thoracic Spine Using a Personalized 3D-Printed Vertebral Body in Adolescent with T9 Primary Bone Tumor. World Neurosurg. 2017 Sep;105:1032.e13-1032.e17. doi: 10.1016/j.wneu.2017.05.133. Epub 2017 May 31.

  PMID: 28578109 RESULT

• Wei F, Li Z, Liu Z, Liu X, Jiang L, Yu M, Xu N, Wu F, Dang L, Zhou H, Li Z, Cai H. Upper cervical spine reconstruction using customized 3D-printed vertebral body in 9 patients with primary tumors involving C2. Ann Transl Med. 2020 Mar;8(6):332. doi: 10.21037/atm.2020.03.32.

  PMID: 32355776 RESULT

• Yang X, Wan W, Gong H, Xiao J. Application of Individualized 3D-Printed Artificial Vertebral Body for Cervicothoracic Reconstruction in a Six-Level Recurrent Chordoma. Turk Neurosurg. 2020;30(1):149-155. doi: 10.5137/1019-5149.JTN.25296-18.2.

  PMID: 31049920 RESULT

• Girolami M, Boriani S, Bandiera S, Barbanti-Brodano G, Ghermandi R, Terzi S, Tedesco G, Evangelisti G, Pipola V, Gasbarrini A. Biomimetic 3D-printed custom-made prosthesis for anterior column reconstruction in the thoracolumbar spine: a tailored option following en bloc resection for spinal tumors : Preliminary results on a case-series of 13 patients. Eur Spine J. 2018 Dec;27(12):3073-3083. doi: 10.1007/s00586-018-5708-8. Epub 2018 Jul 23.

  PMID: 30039254 RESULT

• Dong C, Wei H, Zhu Y, Zhou J, Ma H. Application of Titanium Alloy 3D-Printed Artificial Vertebral Body for Stage III Kummell's Disease Complicated by Neurological Deficits. Clin Interv Aging. 2020 Dec 2;15:2265-2276. doi: 10.2147/CIA.S283809. eCollection 2020.

  PMID: 33293803 RESULT

• Wei F, Xu N, Li Z, Cai H, Zhou F, Yang J, Yu M, Liu X, Sun Y, Zhang K, Pan S, Wu F, Liu Z. A prospective randomized cohort study on 3D-printed artificial vertebral body in single-level anterior cervical corpectomy for cervical spondylotic myelopathy. Ann Transl Med. 2020 Sep;8(17):1070. doi: 10.21037/atm-19-4719.

  PMID: 33145289 RESULT

• Fang T, Zhang M, Yan J, Zhao J, Pan W, Wang X, Zhou Q. Comparative Analysis of 3D-Printed Artificial Vertebral Body Versus Titanium Mesh Cage in Repairing Bone Defects Following Single-Level Anterior Cervical Corpectomy and Fusion. Med Sci Monit. 2021 Feb 7;27:e928022. doi: 10.12659/MSM.928022.

  PMID: 33550326 RESULT

• Girolami M, Sartori M, Monopoli-Forleo D, Ghermandi R, Tedesco G, Evangelisti G, Pipola V, Pesce E, Falzetti L, Fini M, Gasbarrini A. Histological examination of a retrieved custom-made 3D-printed titanium vertebra : Do the fine details obtained by additive manufacturing really promote osteointegration? Eur Spine J. 2021 Oct;30(10):2775-2781. doi: 10.1007/s00586-021-06926-w. Epub 2021 Jul 16.

  PMID: 34279722 RESULT

• Wallace N, Schaffer NE, Aleem IS, Patel R. 3D-printed Patient-specific Spine Implants: A Systematic Review. Clin Spine Surg. 2020 Dec;33(10):400-407. doi: 10.1097/BSD.0000000000001026.

  PMID: 32554986 RESULT

• Yang SH, Xiao FR, Lai DM, Wei CK, Tsuang FY. A Dynamic Interbody Cage Improves Bone Formation in Anterior Cervical Surgery: A Porcine Biomechanical Study. Clin Orthop Relat Res. 2021 Nov 1;479(11):2547-2558. doi: 10.1097/CORR.0000000000001894.

  PMID: 34343157 RESULT

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Fon-Yih Fon-Yih, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fon-Yih Fon-Yih, PhD

CONTACT

0933759026; 8d62535@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 31, 2022
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

TW (1)