Clinical trial NCT04886557: Retrospective Image Analysis of Degenerative Lumbar Disease Patients
Official title: Retrospective Image Analysis of Degenerative Lumbar Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spondylolisthesis
Keywords: Dynesys dynamic stabilization, range of motion
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-05-14
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Range of motion
timeFrame: All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.
Secondary outcomes:
measure: Screw loosening
timeFrame: All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital
Study officials:
References:
citation: St-Pierre GH, Jack A, Siddiqui MM, Henderson RL, Nataraj A. Nonfusion Does Not Prevent Adjacent Segment Disease: Dynesys Long-term Outcomes With Minimum Five-year Follow-up. Spine (Phila Pa 1976). 2016 Feb;41(3):265-73. doi: 10.1097/BRS.0000000000001158.