Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients

Osteoporosis Clinical Trial

— OMC  

Official title:

Biomechanical-matched Titanium Cages(Osteo Match) Versus PEEK Cages in Osteoporotic Lumbar Spine: a Multicenter, Prospective Cohort Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05981222
• Other study ID #: 2019-397-04
• Status: Enrolling by invitation
• Start date: August 1, 2023
• Est. completion date: August 1, 2027

Study information

• Verified date: July 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multicenter, prospective cohort study. The osteoporotic patients requiring posterior lumbar interbody fusion(LIF) with cages are prospectively enrolled and followed up. The patients undergoing LIF with the biomechanical-matched 3D-printed titanium cages (Osteo Match) are compared with those using routine PEEK cages. The hypothesis is that the use of Osteo Match cages can reduce the rate of cage subsidence and increase the rate of lumbar fusion in osteoporotic patients.

Description:

Interbody fusion cages are widely used for the surgical treatment of degenerative lumbar diseases, which can stabilize the spine and promote solid fusion. However, because of population aging and the high rate of osteoporosis in the elderly with lumbar degenerative diseases, the cage subsidence and failure of fusion have been frequently reported. The biomechanical strength (such as elasticity modulus) of routine PEEK cages is mismatched with osteoporotic bone, leading to cage subsidence and nonunion.

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. However, most of the titanium cages still have much higher biomechanical strength than the osteoporotic bone. The new titanium cages named Osteo Match has been first clinically used in Peking University Third Hospital in China. The elastic modulus of Osteo Match cage is matched with that of lumbar spine with different degrees of osteoporosis. Therefore, we hypothesize that patients undergoing LIF with Osteo Match cages can achieve lower rate of cage subsidence and higher rate of lumbar fusion than those using PEEK cages.

The osteoporotic patients requiring posterior lumbar interbody fusion with cages 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 by DXA, CT Hounsfield units, or QCT), 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, CTand certain questions about the clinical outcomes.

The patients used Osteo Match cages are compared with those using conventional PEEK cages. The primary endpoints are the subsidence rate and fusion rate at 6 months follow-up. The secondary endpoints are the subsidence rate and fusion rate at other time point of follow-up , and the clinical outcomes(ODI/JOA/VAS) at every follow-up.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2026
• 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, QCTor CT Hounsfield units

• requiring lumbar interbody fusion with cages within L3-S1

• the type of fusion cage has been chosen by the patients

• informed consent

Exclusion Criteria:

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

• lumbar spondylolisthesis of =II degree

• lumbar scoliosis of >20° or imbalance of spinal alignment

• history of lumbar fusion surgery

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

• vertebral fracture within interbody fusion segement

• ASA of =IV

Related Conditions & MeSH terms

• Degeneration Spine
• Degenerative Lumbar Disease
• Osteoporosis

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 (5)

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. — 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

Zou D, Jiang S, Zhou S, Sun Z, Zhong W, Du G, Li W. Prevalence of Osteoporosis in Patients Undergoing Lumbar Fusion for Lumbar Degenerative Diseases: A Combination of DXA and Hounsfield Units. Spine (Phila Pa 1976). 2020 Apr 1;45(7):E406-E410. doi: 10.1097/BRS.0000000000003284. — View Citation

Zou D, Yue L, Fan Z, Zhao Y, Leng H, Sun Z, Li W. Biomechanical Analysis of Lumbar Interbody Fusion Cages With Various Elastic Moduli in Osteoporotic and Non-osteoporotic Lumbar Spine: A Finite Element Analysis. Global Spine J. 2023 May 3:21925682231166612. doi: 10.1177/21925682231166612. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cage subsidence rate	The presence of cage subsidence > 2mm at x-ray or CT images.	6 months
Primary	Fusion rate	The presence of continuous fusion mass at bone graft site in CT scans and absence of intervertebral mobility on lateral flextion-extension x-ray images.	6 months