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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Oswestry, Verenigd Koninkrijk, SY10 7AG
- Robert Jones and Agnes Hunt Orthopedic Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- All patients with degenerative lumbar spondylolisthesis
Exclusion Criteria:
- Patients with spondylolysis
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Decompression alone
Patients undergone decompression surgery alone
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Decompression with fusion
Patient undergone decompression and lumbar fusion surgery
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Time to Revision
Tijdsspanne: 15 years
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Duration between initial surgery and revision surgery at same level
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15 years
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: olakunle J Alonge, MBBS, FWACS, The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RL1854
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
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