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NOT YET RECRUITING
NCT07670533
NA

The Lumbar Adjacent Segment Stenosis Trial

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

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

Official title: The Lumbar Adjacent Segment Stenosis (LASS) Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2026-08

Completion Date

2032-10

Last Updated

2026-06-26

Healthy Volunteers

No

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.

Locations (3)

Innlandet Hospital Gjøvik

Gjøvik, Norway

Oslo University Hospital HF

Oslo, Norway

University Hospital of North Norway

Tromsø, Norway