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The Lumbar Adjacent Segment Stenosis Trial

NCT07670533 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-06-26

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if there are differences in the effectiveness of decompression surgery alone versus decompression combined with extended fusion in patients with a previous lumbar spinal fusion who now present with symptoms of lumbar adjacent segment stenosis (LASS). The main questions it aims to answer are:

* Does decompression alone differ from decompression combined with extended fusion with regard to clinical outcomes two years after surgery?
* Are there any clinical or radiological characteristics that can predict better or worse outcomes two years after surgery?
* Are there any differences between the treatment groups in terms of health economics?

Researchers will compare decompression surgery alone versus decompression combined with extended fusion to see if there are any differences in treatment effect.

Participants will:

* Be randomized to one of the two surgical procedures
* Visit the clinic four times postoperatively (at three months, 1, 2 and 5 years) for checkups and tests
* Respond to questionnaires before surgery, and three months, 1, 2 and 5 years postoperatively

Conditions

  • Lumbar Adjacent Spinal Stenosis
  • Chronic Low Back and Leg Pain

Interventions

PROCEDURE

Decompression alone

Patients allocated to decompression alone will be offered mid-line preserving decompression technique with the use of a vision-enhancing aid (microscope or magnifying glasses).

PROCEDURE

Decompression with extended fusion

Patients allocated to decompression with extended fusion will be offered decompression with the use of vision enhancement (microscope or magnifying glasses). The procedure for the extended fusion will involve bilateral pedicle screws with autologous bone transplant and/or bone substitutes. The use of an interbody device (cage) or not and decompression technique will be at the discretion of the surgeon. Bone grafts should be placed in the interbody device and either posteriorly and/or anteriorly to the interbody device. Autologous bone can be placed in the intervertebral space without a cage if it is not feasible e.g., due to a too narrow intervertebral disc space. Alternatively a posterior or posterolateral bone grafting can be performed.

Sponsors & Collaborators

  • Sykehuset Innlandet HF

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2032-08-31
Completion
2032-10-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07670533 on ClinicalTrials.gov