ClinicalTrials.Veeva

Menu

Retrospective Image Analysis of Degenerative Lumbar Disease Patients

T

Taipei Veterans General Hospital

Status

Completed

Conditions

Lumbar Spondylolisthesis

Treatments

Procedure: L4-L5 decompression and dynamic instrumentation

Study type

Observational

Funder types

Other

Identifiers

NCT04886557
2017-10-008BC

Details and patient eligibility

About

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.

Full 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.

Enrollment

139 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

139 participants in 1 patient group

DDS fixation
Description:
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.
Treatment:
Procedure: L4-L5 decompression and dynamic instrumentation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems