Retrospective Image Analysis of Degenerative Lumbar Disease Patients

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.

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Key information

Conditions

Lumbar Spondylolisthesis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L4-L5 decompression and dynamic instrumentation

Procedure

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.

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start: 2007
Primary completion: 2013
Study completion: 2018
First posted: May 14, 2021
Registry last updated: May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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