NCT03469791

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 was conducted, now the long-term follow up.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
426

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2007Dec 2027

Study Start

First participant enrolled

September 1, 2007

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
9.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

10.3 years

First QC Date

March 5, 2018

Last Update Submit

March 10, 2025

Conditions

Degenerative Lumbar Spondylolisthesis

Keywords

Degenerative SpondylolisthesisTreatmentDecompression aloneInstrumented fusionOswestry Disability Index

Outcome Measures

Primary Outcomes (1)

  • Responder rate assessed by ODI

    The proportion of participants with an improvement on the Oswestry Disability Index score score more than 30% from preoperative to 12 month and long term 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.

    From date of operation to 12 month follow-up. From date of operation to long-term(7-15 yrs) follow-up

Secondary Outcomes (7)

  • ODI: Mean change and mean follow-up score

    From date of operation to 12 month follow-up and to long term follow-up (7 -15 yrs)

  • NRS leg pain

    From date of operation to 12 month follow-up and long term follow up (7-15 yrs)

  • NRS back pain

    From date of operation to 12 month follow-up and long term follow up (7-15 yrs)

  • GPE scores

    At 12 month follow-up and at long term follow up (7-15yrs)

  • Hospital stay

    Up to 12 months

  • +2 more secondary outcomes

Study Arms (2)

Micro-decompression alone

ACTIVE COMPARATOR

In Surgical treatment of Degenerative Spondylolisthesis patients are operated on with a midline-precerving decompression without fusion

Procedure: Surgical treatment of Degenerative Spondylolisthesis

Decompression and instrumented fusion

ACTIVE COMPARATOR

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

Interventions

Surgical treatment of Degenerative SpondylolisthesisPROCEDURE
Decompression and instrumented fusionMicro-decompression alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kysthospitalet i Hagevik, Orthopeadic Clinic, Haukeland University Hospital

Bergen, Hagevik, 5217, Norway

Location

Study Officials

  • Ivar Magne Austevoll, PhD

    Haukeland University Hosptal

    PRINCIPAL INVESTIGATOR

  • Eric Loratang Kgomotso, MD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-inferiority cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 19, 2018

Study Start

September 1, 2007

Primary Completion

December 31, 2017

Study Completion (Estimated)

December 31, 2027

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

NO(1)