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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04886557
Other study ID # 2017-10-008BC
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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