Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients (OMC)

January 19, 2025 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Osteo Match cage
Patients undergoing posterior lumbar interbody fusion with Osteo Match Cages
Peek Cage
Patients undergoing posterior lumbar interbody fusion with PEEK Cages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cage subsidence rate
Time Frame: 6 months
The presence of cage subsidence > 2mm at x-ray or CT images.
6 months
Fusion rate
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Chair: Weishi Li, Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-397-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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