Lumbar SpondylolisthesisNCT04886557
Retrospective Image Analysis of Degenerative Lumbar Disease Patients
An observational study of Lumbar Spondylolisthesis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spondylolisthesis
- What is being tested?
- L4-L5 decompression and dynamic instrumentation
- Type of treatment
- Surgery or procedure
- How many people
- 139 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2007to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients
- Diagnosed with degenerative spondylolisthesis over L4-L5
- Received DDS
- Received a minimum of 2-year follow-up were reviewed.
Who cannot join
- presence of degenerative scoliosis or spinal deformity,
- prior spine surgery,
- lost to follow-up, or
- failure to complete the questionnaires or radiographic examinations.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital
Taipei, 112
About this study
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.
Read the 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.
- Conditions
- Lumbar Spondylolisthesis
- Being tested
- L4-L5 decompression and dynamic instrumentation
- Keywords
- Dynesys dynamic stabilization, range of motion
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L4-L5 decompression and dynamic instrumentationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| DDS fixation | Adult patients with degenerative spondylolisthesis over L4-L5 received DDS with a minimum of 2-year follow-up were reviewed. Surgical indications were patients who failed to respond to conservative treatment for at least 6 months. The exclusion criteria were: (1) presence of degenerative scoliosis or spinal deformity, (2) prior spine surgery, (3) lost to follow-up, or (4) failure to complete the questionnaires or radiographic examinations. Receives: Procedure: L4-L5 decompression and dynamic instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.
Secondary outcomes (1)
Screw loosening
Radiographic screw-loosening was defined as presence of a halo or double-halo sign on plain x-ray films
Measured: All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study startJan 2007
- Primary completionDec 2013
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886557
- Sponsor's protocol ID
- 2017-10-008BC
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26335675
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Image Analysis of Degenerative Lumbar Disease Patients
- ClinicalTrials.gov ID
- NCT04886557
- Acronym / sponsor ID
- 2017-10-008BC
- Conditions
- Lumbar Spondylolisthesis
- Keywords
- Dynesys dynamic stabilization, range of motion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Jan 2007 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DDS fixation | – | Procedure: L4-L5 decompression and dynamic instrumentationAdult patients with degenerative spondylolisthesis over L4-L5 received DDS with a minimum of 2-year follow-up were reviewed. Surgical indications were patients who failed to respond to conservative treatment for at least 6 months. The exclusion criteria were: (1) presence of degenerative scoliosis or spinal deformity, (2) prior spine surgery, (3) lost to follow-up, or (4) failure to complete the questionnaires or radiographic examinations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adult patients
- Diagnosed with degenerative spondylolisthesis over L4-L5
- Received DDS
- Received a minimum of 2-year follow-up were reviewed.
Key exclusion criteria (4 listed)
- presence of degenerative scoliosis or spinal deformity,
- prior spine surgery,
- lost to follow-up, or
- failure to complete the questionnaires or radiographic examinations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L4-L5 decompression and dynamic instrumentationAll 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. | Procedure or surgery | DDS fixation |
Primary outcome
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
1 secondary outcome
Screw loosening
Time frame: All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Results publication: PubMed 26335675St-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spondylolisthesis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04886557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.