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Retrospective Image Analysis of Degenerative Lumbar Disease Patients

Retrospective Image Analysis of Degenerative Lumbar Disease Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04886557
Enrollment
139
Registered
2021-05-14
Start date
2007-01-31
Completion date
2018-12-31
Last updated
2021-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spondylolisthesis

Keywords

Dynesys dynamic stabilization, range of motion

Brief summary

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.

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.

Interventions

PROCEDUREL4-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.

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Range of motionAll 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

Secondary

MeasureTime frameDescription
Screw looseningAll 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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026