- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05386381
Survivorship of Decompression Alone Vs Decomp With Fusion in DLS and LCS
Long Term Survivorship of Decompression Alone Versus Decompression With Fusion in Patients With Degenerative Lumbar Spondylolisthesis and Lumbar Canal Stenosis
There has been a long-standing controversy on the operative treatment of Degenerative Lumbar Spondylolisthesis (DLS) with Lumbar Canal Stenosis (LCS), especially whether the addition of fusion to decompression is necessary. Many believe that decompression alone (D) by either using midline preserving fenestration techniques (fenestration by laminotomy and medial facetectomy) or with a spinous process osteotomy (SPO) is enough for treatment of patients with DLS while others believe that a fusion (D+F) should be added in all cases.
The study aims to determine if decompression alone performs better or worse in the long term than decompression with fusion in a large cohort of patients who have DLS with LCS. It also aims to determine if the decompression technique of midline-sparing fenestration or spinous process osteotomy make a difference to survival in cases of DLS with LCS.
Study Overview
Status
Conditions
Detailed Description
The study aims to utilize already obtained data from the clinical service, obtainable from the electronic patient records (EPR). It would be a retrospective review of data on patients with DLS treated operatively.
All data collected will be anonymized prior to any analysis. The primary outcome to be analyzed is the time to repeat surgery/procedure at the previously operated vertebral level. This will be regarded as failure of the original surgery and will be used in the survival analysis. All analysis will be done at the RJAH site. As the study will use anonymized data collected through the clinical service, individual patient consent will not be obtained.
All data used in this study has been obtained during the patients' routine clinical care and follow up. No further tests or scans other than routine patient care will be performed. The data for this study will be collected and anonymized before any statistics is performed. Only data for patients with DLS + LCS treated operatively between 1st January 2002 and 31st December 2006 that have had at least 15 years of follow up will be extracted. The data is currently stored on the Trust secure patient record system. As all the data will be anonymized no consents will be required. Data collected will include age, gender, date of admission, consultant, primary procedure date, length of hospital stay, date of death, type of surgery (fenestration/fenestration+fusion/spinous process osteotomy), fusion/no fusion, type of fusion (instrumented/non-instrumented/interbody), unilateral/bilateral, laminectomy/no laminectomy, number of levels, discectomy, post op complications, revision surgery, date of revision, coexisting problems.
Analysis of the data will address the following: Does difference in technique of lumbar decompression or adding fusion affect long term survivorship in degenerative lumbar spondylolisthesis with canal stenosis (DLS +LCS)? Does decompression alone perform better or worse in the long term than decompression with fusion in a large cohort of patients who have DLS with LCS. Does decompression technique of midline-sparing fenestration or spinous process osteotomy make a difference to survival in cases of DLS with LCS
Statistics The primary outcome which is the time to failure will be used to generate the Kaplan-Meier survival function for each of the three surgical techniques. The survival curves will then be compared using the Mantel-Cox (Log rank) test for statistical significance. Statistical significance will be set at p < 0.05. A sub group analysis will be performed.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Oswestry, United Kingdom, SY10 7AG
- Robert Jones and Agnes Hunt Orthopedic Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients with degenerative lumbar spondylolisthesis
Exclusion Criteria:
- Patients with spondylolysis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Decompression alone
Patients undergone decompression surgery alone
|
Decompression with fusion
Patient undergone decompression and lumbar fusion surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Revision
Time Frame: 15 years
|
Duration between initial surgery and revision surgery at same level
|
15 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: olakunle J Alonge, MBBS, FWACS, The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RL1854
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lumbar Spondylolisthesis Involving L4-L5
-
Banc de Sang i TeixitsTFS Trial Form Support; Ministerio de Sanidad, Servicios Sociales e Igualdad; Ministerio de Ciencia e Innovación, SpainCompletedLumbar Spondylolisthesis Involving L4-L5, and/or | Degenerative Discopathy Involving L4-L5Spain
-
Geistlich Pharma AGRecruitingLumbar Spinal Stenosis | Lumbar Disc Degeneration | Lumbar Spondylolisthesis Involving L4-L5 | Lumbar Spondylolisthesis Involving L5-S1Germany
-
Tanta Universitymona bologh elmorad,MD; mohmed naser shaddad,MDCompletedDouble Level Lumbar Spondylolisthesis (L3-L5) | Posterior Lumbar Interbody Fusion (PLIF) | Lumbar Fixation SurgeryEgypt
-
Lahey ClinicDePuy SynthesActive, not recruitingLumbar Spondylolisthesis | Lumbar Spondylosis | Degenerative SpondylolisthesisUnited States
-
Methodist Health SystemActive, not recruitingLumbar Spondylolisthesis | Lumbar Spine DegenerationUnited States
-
Shane BurchEli Lilly and CompanyCompletedLumbar Spondylolisthesis | Lumbar Spondylosis | Adult Degenerative Lumbar ScoliosisUnited States
-
Bioventus LLCRecruitingDegenerative Disc Disease | Lumbar Spondylolisthesis | Lumbar Spondylosis | Lumbar Spine Disease | Lumbar Spine InstabilityUnited States
-
Lahey ClinicTerminatedLumbar Spinal Stenosis | Lumbar Spondylolisthesis | Degenerative Spondylolisthesis | Grade 1 SpondylolisthesisUnited States, Canada
-
Neurocenter of Southern SwitzerlandMaastricht University; Schulthess KlinikRecruitingLumbar Spinal Stenosis | Lumbar Spondylolisthesis | Spinal Disease | Lumbar InstabilitySwitzerland
-
Twin Cities Spine CenterNot yet recruitingLumbar Spondylolisthesis | Spine Fusion | Lumbar StenosisUnited States