3D-printed Porous Titanium Alloy Cages Versus PEEK Cages in Patients With Osteoporosis

Osteoporosis Clinical Trial

— 3DCOP  

Official title:

3D-printed Porous Titanium Alloy Cages Versus PEEK Cages: Pedicle Screw Loosening Rate and Fusion Rate in Patients With Osteoporosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04086784
• Other study ID #: M2019270
• Status: Enrolling by invitation
• Start date: January 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective,observational single-center study. The osteoporotic patients requiring posterior lumbar interbody fusion(PLIF) with cages at the lowest fusion segment are prospectively enrolled and followed up. The patients undergoing PLIF with the 3D-printed porous titanium alloy cages are compared with those using PEEK cages. The hypothesis is that the use of 3D-printed porous titanium alloy cages can reduce the rate of pedicle screw loosening and increase the rate of lumbar fusion in osteoporotic patients.

Description:

Pedicle screw fixation is a widely used technique for the surgical treatment of degenerative lumbar diseases, which can stabilize the spine before solid fusion and restore spinal balance. However, because of population aging and the high rate of osteoporosis in the elderly with lumbar degenerative diseases, the pedicle screw loosening has become a frequently reported complication. The bone-screw interface in osteoporotic spine is unstable, leading to reduced pull-out force and cut-out force. Most of the previous studies only focused on the methods used to directly strengthen the pedicle screws, few of them explored the feasibility of reducing the loosening rate by accelerating the lumbar fusion precess.

The 3D-printed porous titanium alloy cages have been proved to have advantages in speeding up and enhancing the lumbar fusion over conventional PEEK cages. Therefore, we hypothesize that patients undergoing PLIF with 3D-printed cages can achieve lumbar fusion earlier than those using PEEK cages, thus the 3D-printed cages can reduce the load on pedicle screws sooner than PEEK cages. Finally, the 3D-printed cages can reduce the loosening rate and increase the fusion rate.

The osteoporotic patients requiring posterior lumbar interbody fusion(PLIF) with cages at the lowest fusion segment are prospectively enrolled and followed up. The researchers will invite appropriate patients to participate in the study after their surgical plans are determined. General patients data are collected after informed consent, such as age, gender, weight, height, bone mineral density measured in T-scores and Hounsfield units, detailed surgical plans, and etc. They are followed up at 3, 6, 12, and 24 months according to our clinical routine, including lumbar x-ray and certain questions about the clinical outcomes. In addition, this study requires the patients to have lumbar CT scans when the fusion status is unclear in x-ray, especially for the 6 months follow-up.

The patients undergoing PLIF with the 3D-printed porous titanium alloy cages are compared with those using conventional PEEK cages. The primary endpoints are the loosening rate and fusion rate at 6 months follow-up. The secondary endpoints are the loosening rate and fusion rate at other time point of follow-up , and the clinical outcomes(ODI and VAS) at every follow-up.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• aged= 50 years old

• lumbar degenerative diseases requiring lumbar fusion with pedicle screw fixation, such as degenerative lumbar spinal stenosis, degenerative lumbar spondylolisthesis.

• no response to nonoperative treatment of at least 3 months

• osteoporosis diagnosed by any method for bone mineral density evaluation, such as DXA, QCT,or vertebral Hounsfield units

• the lowest instrumented vertebrae were at L5 or S1

• the surgical plan includes lumbar interbody fusion with cages at the lowest fusion level

• informed consent

Exclusion Criteria:

• the surgical plan includes any techniques used to strengthen the fixation,such as augmentation of the pedicle screw with bone cement

• no lumbar CT scans within 3 months before the surgery

• no dual energy x-ray absorptiometry within 6 months before the surgery

• spondylolysis

• allergic to metal

• history of lumbar fusion surgery

• cervical myelopathy,thoracic spinal stenosis, motor neuron disease,tuberculosis of spine,spinal tumor

Related Conditions & MeSH terms

• Degeneration Spine
• Degenerative Disc Disease
• Degenerative Lumbar Spinal Stenosis
• Intervertebral Disc Degeneration
• Osteoporosis
• Spinal Stenosis

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

Amirouche F, Solitro GF, Magnan BP. Stability and Spine Pedicle Screws Fixation Strength-A Comparative Study of Bone Density and Insertion Angle. Spine Deform. 2016 Jul;4(4):261-267. doi: 10.1016/j.jspd.2015.12.008. Epub 2016 Jun 16. — View Citation

Bokov A, Bulkin A, Aleynik A, Kutlaeva M, Mlyavykh S. Pedicle Screws Loosening in Patients With Degenerative Diseases of the Lumbar Spine: Potential Risk Factors and Relative Contribution. Global Spine J. 2019 Feb;9(1):55-61. doi: 10.1177/2192568218772302. Epub 2018 May 24. — View Citation

Bredow J, Boese CK, Werner CM, Siewe J, Löhrer L, Zarghooni K, Eysel P, Scheyerer MJ. Predictive validity of preoperative CT scans and the risk of pedicle screw loosening in spinal surgery. Arch Orthop Trauma Surg. 2016 Aug;136(8):1063-7. doi: 10.1007/s00402-016-2487-8. Epub 2016 Jun 16. — View Citation

Chen P, Li Z, Hu Y. Prevalence of osteoporosis in China: a meta-analysis and systematic review. BMC Public Health. 2016 Oct 3;16(1):1039. Review. — View Citation

Galbusera F, Volkheimer D, Reitmaier S, Berger-Roscher N, Kienle A, Wilke HJ. Pedicle screw loosening: a clinically relevant complication? Eur Spine J. 2015 May;24(5):1005-16. doi: 10.1007/s00586-015-3768-6. Epub 2015 Jan 24. Review. — View Citation

Goldstein CL, Brodke DS, Choma TJ. Surgical Management of Spinal Conditions in the Elderly Osteoporotic Spine. Neurosurgery. 2015 Oct;77 Suppl 4:S98-107. doi: 10.1227/NEU.0000000000000948. Review. — View Citation

Janssen I, Ryang YM, Gempt J, Bette S, Gerhardt J, Kirschke JS, Meyer B. Risk of cement leakage and pulmonary embolism by bone cement-augmented pedicle screw fixation of the thoracolumbar spine. Spine J. 2017 Jun;17(6):837-844. doi: 10.1016/j.spinee.2017.01.009. Epub 2017 Jan 17. — View Citation

Li P, Jiang W, Yan J, Hu K, Han Z, Wang B, Zhao Y, Cui G, Wang Z, Mao K, Wang Y, Cui F. A novel 3D printed cage with microporous structure and in vivo fusion function. J Biomed Mater Res A. 2019 Jul;107(7):1386-1392. doi: 10.1002/jbm.a.36652. Epub 2019 Mar 18. — View Citation

McGilvray KC, Easley J, Seim HB, Regan D, Berven SH, Hsu WK, Mroz TE, Puttlitz CM. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J. 2018 Jul;18(7):1250-1260. doi: 10.1016/j.spinee.2018.02.018. Epub 2018 Feb 26. — View Citation

Okuyama K, Abe E, Suzuki T, Tamura Y, Chiba M, Sato K. Influence of bone mineral density on pedicle screw fixation: a study of pedicle screw fixation augmenting posterior lumbar interbody fusion in elderly patients. Spine J. 2001 Nov-Dec;1(6):402-7. — View Citation

Pannell WC, Savin DD, Scott TP, Wang JC, Daubs MD. Trends in the surgical treatment of lumbar spine disease in the United States. Spine J. 2015 Aug 1;15(8):1719-27. doi: 10.1016/j.spinee.2013.10.014. Epub 2013 Oct 31. — View Citation

Tokuhashi Y, Matsuzaki H, Oda H, Uei H. Clinical course and significance of the clear zone around the pedicle screws in the lumbar degenerative disease. Spine (Phila Pa 1976). 2008 Apr 15;33(8):903-8. doi: 10.1097/BRS.0b013e31816b1eff. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pedicle screw loosening rate at the lowest instrumented vertebrae	The presence of radiolucent zones of = 1mm thick around the pedicle screws, broken screws, or obvious screw back-out and cut-out on x-ray images.	6 months
Primary	Fusion rate at the lowest fusion level	The presence of continuous fusion mass at bone graft site in CT scans and less than 3 degree of intervertebral mobility on lateral flextion-extension x-ray images.	6 months
Secondary	Pedicle screw loosening rate at the lowest instrumented vertebrae	The presence of radiolucent zones of = 1mm thick around the pedicle screws, broken screws, or obvious screw back-out and cut-out on x-ray images.	3 months;12 months; 24 months
Secondary	Fusion rate at the lowest fusion level	The presence of continuous fusion mass at bone graft site in CT scans and less than 3 degree of intervertebral mobility on lateral flextion-extension x-ray images.	3 months;12 months; 24 months
Secondary	Disability	The Oswestry Disability Index (ODI) (0-100) is used to assess disability.	3 months; 6 months;12 months; 24 months
Secondary	Back pain	The Visual Analog Scale (VAS 0-10) is used the evaluate back pain.	3 months; 6 months;12 months; 24 months
Secondary	Leg pain	The Visual Analog Scale (VAS 0-10) is used the evaluate leg pain.	3 months; 6 months;12 months; 24 months