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

September 12, 2021 updated by: Li Weishi, Peking University Third Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

90

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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, 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pedicle screw loosening rate at the lowest instrumented vertebrae
Time Frame: 6 months
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
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pedicle screw loosening rate at the lowest instrumented vertebrae
Time Frame: 3 months;12 months; 24 months
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
Fusion rate at the lowest fusion level
Time Frame: 3 months;12 months; 24 months
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
Disability
Time Frame: 3 months; 6 months;12 months; 24 months
The Oswestry Disability Index (ODI) (0-100) is used to assess disability.
3 months; 6 months;12 months; 24 months
Back pain
Time Frame: 3 months; 6 months;12 months; 24 months
The Visual Analog Scale (VAS 0-10) is used the evaluate back pain.
3 months; 6 months;12 months; 24 months
Leg pain
Time Frame: 3 months; 6 months;12 months; 24 months
The Visual Analog Scale (VAS 0-10) is used the evaluate leg pain.
3 months; 6 months;12 months; 24 months

Collaborators and Investigators

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

Sponsor

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)

January 15, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 10, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 12, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2019270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We will make the clinical study report available for half a year after the publication of the results of the study.

IPD Sharing Time Frame

The IPD will become available for half a year after the publication of the results of the study.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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