Retrospective Image Analysis of Degenerative Lumbar Disease Patients

Lumbar Spondylolisthesis Clinical Trial

Official title:

Retrospective Image Analysis of Degenerative Lumbar Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04886557
• Other study ID #: 2017-10-008BC
• Status: Completed
• Start date: January 2007
• Est. completion date: December 2018

Study information

• Verified date: May 2021
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 2018
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Spondylolisthesis
• Spondylolisthesis

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of motion	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	Screw loosening	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.