Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients

NCT05981222 | Enrolling By Invitation

• 1 other identifier: 2019-397-04
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Degenerative Lumbar Disease; Degeneration Spine

Keywords

Osteoporosis; Cage subsidence; Lumbar fusion; Osteo Match

Outcome Measures

Primary Outcomes (2)

• Cage subsidence rate

  The presence of cage subsidence \> 2mm at x-ray or CT images.

  6 months

• 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

Study Arms (2)

Osteo Match cage

Patients undergoing posterior lumbar interbody fusion with Osteo Match Cages

Peek Cage

Patients undergoing posterior lumbar interbody fusion with PEEK Cages

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

The osteoporotic patients requiring lumbar interbody fusion with cages 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, 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (5)

• 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. 2024 Sep;14(7):2053-2061. doi: 10.1177/21925682231166612. Epub 2023 May 3.

  PMID: 37132375 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

• 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

• 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.

  PMID: 31725127 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Weishi Li

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CN (1)