Retrospective Image Analysis of Degenerative Lumbar Disease Patients

May 12, 2021 updated by: Taipei Veterans General Hospital, Taiwan
The Dynesys dynamic stabilization (DDS) system is considered a motion-preserving device. However, studies addressing the change in the range of motion (ROM) are limited. Therefore, this study aimed to investigate the factors influencing ROM change at the index surgical level, supra-index level, and whole lumbar spine, in addition to the association between ROM preservation and the incidence of screw-loosening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Decompression with instrumented fusion is an effective surgical intervention for lumbar degenerative spondylolisthesis with spinal stenosis. However, the range of motion (ROM) decreased at the index surgical level may lead to an increased ROM at the non-surgical level, increase biomechanical stress at the transitional adjacent segment, and lead to adjacent segment degeneration (ASD) .

The Dynesys dynamic stabilization (DDS) system is a pedicle screw-based, motion-preserving, and non-fusion stabilization developed as an alternative to the rigid instrumented fusion for degenerative spondylolisthesis. The aim of the DDS is to maintain segmental motion at index levels and to reduce the incidence of ASD. However, the actual impact of ROM has remained elusive. Prior studies have reported an average ROM loss of 1.1º to 17.3º 7 at index surgical level at an average of 24 months follow-up.

The change of ROM at index surgical, supra-index, and whole lumbar spine following DDS remains unclear. This study aims to investigate the factors influencing the ROM change at index surgical level, supra-index level, and whole lumbar spine, and the association between ROM preservation and the incidence of screw-loosening.

Study Type

Observational

Enrollment (Actual)

139

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

  • Taiwan
      • Taipei, Taiwan, 112
        • Dep. of Orthopedics and Traumatology, Taipei Veterans General 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with degenerative spondylolisthesis over L4-L5 who failed to respond to conservative treatment for at least 6 months and received Dynesys instrumentation.

Description

Inclusion Criteria:

  • Adult patients
  • Diagnosed with degenerative spondylolisthesis over L4-L5
  • Received DDS
  • Received a minimum of 2-year follow-up were reviewed.

Exclusion Criteria:

  • presence of degenerative scoliosis or spinal deformity,
  • prior spine surgery,
  • lost to follow-up, or
  • failure to complete the questionnaires or radiographic examinations.

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: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DDS fixation
Adult patients with degenerative spondylolisthesis over L4-L5 received DDS with a minimum of 2-year follow-up were reviewed. Surgical indications were patients who failed to respond to conservative treatment for at least 6 months. The exclusion criteria were: (1) presence of degenerative scoliosis or spinal deformity, (2) prior spine surgery, (3) lost to follow-up, or (4) failure to complete the questionnaires or radiographic examinations.
Procedure: L4-L5 decompression and dynamic instrumentation
All surgeries were performed by a senior surgeon using a traditional midline approach. Stability-preserving lumbar decompression with facet joint undercutting was performed to preserve the facet joints as much as possible. In cases of severe stenosis, a bilateral partial facetectomy (< 25%) was performed for adequate decompression. Posterior tension of the supra- and inter-spinous ligaments was preserved at the most cranial level. Patients were encouraged to ambulate after drain removal and wear a soft lumbar orthosis for at least 3 months after the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.
The ROM change at index surgical level, supra-index level, and whole lumbar spine in degenerative lumbar diseased patients received dynesys dynamic instrumentation
All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screw loosening
Time Frame: All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.
Radiographic screw-loosening was defined as presence of a halo or double-halo sign on plain x-ray films
All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.

Collaborators and Investigators

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

Sponsor

Taipei Veterans General Hospital, Taiwan

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 1, 2007

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-10-008BC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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