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

NCT04086784 | Unknown

• 1 other identifier: M2019270
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Degenerative Disc Disease; Degenerative Lumbar Spinal Stenosis; Degeneration Spine

Keywords

3D-printed Porous Titanium Alloy cage;PEEK cage;Osteoporosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Pedicle screw loosening rate at the lowest instrumented vertebrae

  3 months;12 months; 24 months

• Fusion rate at the lowest fusion level

  3 months;12 months; 24 months

• Disability

  3 months; 6 months;12 months; 24 months

• Back pain

  3 months; 6 months;12 months; 24 months

• Leg pain

  3 months; 6 months;12 months; 24 months

Study Arms (2)

3D-printed Cage

Patients undergoing posterior lumbar interbody fusion with 3D-printed Porous Titanium Alloy Cages at the lowest fusion segment

Peek Cage

Patients undergoing posterior lumbar interbody fusion with PEEK Cages at the lowest fusion segment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the orthopaedic department of the Peking University Third Hospital, the osteoporotic in-patients requiring lumbar fusion with pedicle screw for lumbar degenerative diseases are invited to participate in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (12)

• 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.

  PMID: 24184652 BACKGROUND

• 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.

  PMID: 27927514 BACKGROUND

• 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. doi: 10.1016/s1529-9430(01)00078-x.

  PMID: 14588296 BACKGROUND

• Bredow J, Boese CK, Werner CM, Siewe J, Lohrer 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.

  PMID: 27312862 BACKGROUND

• 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. doi: 10.1186/s12889-016-3712-7.

  PMID: 27716144 BACKGROUND

• 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.

  PMID: 25616349 BACKGROUND

• 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.

  PMID: 18404111 BACKGROUND

• 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.

  PMID: 30775209 BACKGROUND

• 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.

  PMID: 26378363 BACKGROUND

• 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.

  PMID: 28108403 BACKGROUND

• 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.

  PMID: 29496624 BACKGROUND

• 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.

  PMID: 30724479 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Diseases

Study Officials

• Weishi Li, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the orthopaedic department

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: January 15, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The IPD will become available for half a year after the publication of the results of the study.
• Access Criteria: The IPD is available to the readers of the journal in which our research is published. The corresponding author of the published papers will review the requests.

Locations

CN (1)