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Degenerative Spondylolisthesis; Micro-decompression Alone vs Decompression Plus Instrumented Fusion (DS-registry)

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ClinicalTrials.gov Identifier: NCT03469791
Recruitment Status : Active, not recruiting
First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
In many countries a majority of patients with degenerative spondylolisthesis are operated on with decompression plus instrumented fusion, but the scientific evidence for adding fusion is controversial. To evaluate whether micro-decompression alone is as good as (non-inferior to) decompression plus instrumented fusion, a study with data from the Norwegian Registry for Spine Surgery will be conducted.

Condition or disease Intervention/treatment Phase
Degenerative Lumbar Spondylolisthesis Procedure: Surgical treatment of Degenerative Spondylolisthesis Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 426 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-inferiority cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Less Invasive Decompression Alone as Good as Decompression Plus Instrumented Fusion for Lumbar Spinal Degenerative Spondylolisthesis? A Pragmatic Comparative Non-inferiority Observational Study From the Norwegian Registry for Spine Surgery
Actual Study Start Date : September 1, 2007
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Active Comparator: Micro-decompression alone
In Surgical treatment of Degenerative Spondylolisthesis patients are operated on with a midline-precerving decompression without fusion
Procedure: Surgical treatment of Degenerative Spondylolisthesis
Active Comparator: Decompression and instrumented fusion
In Surgical treatment of Degenerative Spondylolisthesis patients are operated on with a decompression followed by an instrumental fusion with or without an additional Cage
Procedure: Surgical treatment of Degenerative Spondylolisthesis



Primary Outcome Measures :
  1. Responder rate assessed by ODI [ Time Frame: From date of operation to 12 month follow-up ]
    The proportion of participants with an improvement on the Oswestry Disability Index score score more than 30% from preoperative to 12 month follow-up.ODI is a self-reported instrument comprising 10 sections where the patient is supposed to mark the most appropriate item.The sum score range from 0 to 100 were 100 represent the greatest impairment.


Secondary Outcome Measures :
  1. ODI: Mean change and mean follow-up score [ Time Frame: From date of operation to 12 month follow-up ]
    Mean change from date of operation to 3 month follow-up, from 3 to 12 month follow-up and the mean follow-up score at 12 month

  2. NRS leg pain [ Time Frame: From date of operation to 12 month follow-up ]
    Mean change from date of operation to 3 month follow-up, from 3 to 12 month follow-up and the mean follow-up score at 12 month for the Numeric Rating Scale [(NRS; which ranges from 0 to 10 (worst pain imaginable)] for leg pain.

  3. NRS back pain [ Time Frame: From date of operation to 12 month follow-up ]
    Mean change from date of operation to 3 month follow-up, from 3 to 12 month follow-up and the mean follow-up score at 12 month for NRS back pain

  4. GPE scores [ Time Frame: At 12 month follow-up ]
    Global Perceived Effect scale (GPE; a global assessment of patient-rated satisfaction with treatment outcome, with the answers 'completely recovered'=6, 'much improved'=5, 'slightly improved'=4, 'unchanged'=3, 'slightly worse'=2, 'much worse'=1 and 'worse than ever'=0. The GPE-responses will be trichotomised into 'substantially improved' ('completely recovered' and 'much improved'), 'slight or no change' ('slightly improved', 'unchanged' and 'slightly worse') and 'substantially deteriorated' ('much worse' and 'worse than ever')

  5. Hospital stay [ Time Frame: During hospital stay ]
    The length of hospital stay

  6. Operation time [ Time Frame: Perioperative ]
    The duration of surgery

  7. Complications [ Time Frame: From date of operation to 3 month follow-up ]
    The rate of perioperative complications and adverse events registered on the surgeon form and the rate of patient-reported complications and adverse events the first 3 months postoperative.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • operated between September 2007 and December 2015 labeled in the registry with both 'Spinal stenosis' and 'Degenerative spondylolisthesis'
  • operated on with decompression with or without an additional fusion

Exclusion Criteria:

  • operated with an anterior approach
  • had a former operation at index Level
  • was labeled with a degenerative scoliose
  • was operated in more than 2 Levels
  • was operated with non-instrumented fusion
  • operated with a standard laminectomy with removing of the posterior midline structures or operated without magnifying devices was excluded from the micro-decompression group

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469791


Locations
Norway
Kysthospitalet i Hagevik, Orthopeadic Clinic, Haukeland University Hospital
Bergen, Hagevik, Norway, 5217
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Ivar Magne Austevoll, MD Haukeland University Hosptal

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03469791     History of Changes
Other Study ID Numbers: 2014/344
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:
Degenerative Spondylolisthesis
Treatment
Decompression alone
Instrumented fusion
Oswestry Disability Index

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases