Pedicle Screw Fixation in Osteoporotic Lumbar Spine (PSFOLS)

July 9, 2022 updated by: Peking University Third Hospital

Pedicle Screw Fixation in Osteoporotic Patients With Degenerative Lumbar Diseases: a Prospective Cohort Study

This is a prospective, observational single-center study. The osteoporotic patients requiring pedicle screw fixation for lumbar degenerative diseases are prospectively enrolled and followed up. This study mainly focuses on the most common osteoporosis-related surgical complications, which are pedicle screw loosening and the failure of lumbar fusion. The global and local bone mineral density(BMD) are evaluated with DXA, vertebral CT Hounsfield units(HU) before the surgery. The mechanical strength of the bone mass within the screw trajectory is also measured with a customized device during the surgery. We explored the effect of BMD on the pedicle screw loosening rate and fusion rate. In addition, the patients undergoing lumbar fixation with conventional pedicle screws without the use of bone cement are compared with those undergoing the fixation augmented with bone cement. The objective is to offer more detailed clinical evidence to guide the use of pedicle screw augmentation techniques 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.

Previous studies have widely reported the bone cement augmentation techniques used to directly strengthen the pedicle screws. It has been proved that cement-augmented pedicle screw fixation is associated with lower loosening rate and higher fusion rate. However, the use of cement can lead to cement leakage and pulmonary embolism, and need extra cost. Therefore, it is very important to identify the correlation between degree of osteoporosis and screw loosening risk , and to establish the indications for cement augmentation in osteoporotic patients.

The osteoporotic patients requiring posterior lumbar fusion with pedicle screw fixation 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, the mechanical strength of the bone mass within the screw trajectory, 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 because its advantage in judging the fusion status. In addition, the ODI and VAS scores are also routinely recorded.

The patients undergoing conventional pedicle screw fixation without cement augmentation are compared with those undergoing the fixation augmented with bone cement. The primary endpoints are the loosening rate and fusion rate at 12 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. We also explored the correlation between the BMD information measured with different methods and the patients outcomes, in order to find the high-risk patient group.

Study Type

Observational

Enrollment (Anticipated)

200

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 pedicle screw fixation 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 and etc.
  • 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
  • informed consent

Exclusion Criteria:

  • no lumbar CT scans within 3 months before the surgery
  • no dual energy x-ray absorptiometry within 6 months before the surgery
  • 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
Conventional pedicle screw fixation
Patients undergoing conventional pedicle screw fixation without the use of bone cement.
Cement-augmented pedicle screw fixation
Patients undergoing pedicle screw fixation augmented with bone cement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pedicle screw loosening
Time Frame: 12 months
The presence of radiolucent zones of ≥1mm thick around any pedicle screw, broken screws, or obvious screw back-out and cut-out on x-ray or CT images
12 months
Lumbar fusion
Time Frame: 12 months
The presence of continuous fusion mass at any fusion segment in CT scans and no obvious intervertebral mobility at any fusion segment on lateral flexion-extension x-ray images.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pedicle screw loosening
Time Frame: 3 months; 6 months; 24 months
The presence of radiolucent zones of ≥1mm thick around any pedicle screw, broken screws, or obvious screw back-out and cut-out on x-ray or CT images
3 months; 6 months; 24 months
Lumbar fusion
Time Frame: 3 months; 6 months; 24 months
The presence of continuous fusion mass at any fusion segment in CT scans and no obvious intervertebral mobility at any fusion segment on lateral flexion-extension x-ray images.
3 months; 6 months; 24 months
The Oswestry Disability Index（ODI）
Time Frame: 3 months; 12 months; 6 months; 24 months
The Oswestry Disability Index (ODI) (%，0-100) is used to assess disability.
3 months; 12 months; 6 months; 24 months
VAS score for low back pain
Time Frame: 3 months; 12 months; 6 months; 24 months
The Visual Analog Scale (VAS 0-10) is used the evaluate low back pain.
3 months; 12 months; 6 months; 24 months
VAS score for leg pain
Time Frame: 3 months; 12 months; 6 months; 24 months
The Visual Analog Scale (VAS 0-10) is used the evaluate leg pain.
3 months; 12 months; 6 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)

February 3, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 9, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BYSYDL2019006

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 half a year after the publication of the results of the study.

IPD Sharing Time Frame

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

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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