The Lumbar Adjacent Segment Stenosis Trial

ConditionsLumbar Adjacent Spinal Stenosis Chronic Low Back and Leg Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorOslo University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical symptoms of spinal stenosis, defined as neurogenic claudication or radiating pain into the lower limbs with duration >6 months

MRI-confirmed adjacent segment stenosis, proximal to a previously fused lumbar segment (fusion of maximum two levels between L1 and S1, any type of previous lumbar fixation procedure).

CT-verified solid fusion

Minimum time since previous fusion: one year

Disqualifiers

Previous surgery at the actual adjacent stenotic level.

More than two fused lumbar levels.

Non-union (pseudoarthrosis) at the previously surgically fused level, radiologically verified.

Foraminal stenosis grade 3 at the adjacent level.

Trial design

Design model

Parallel

Treatments tested in this trial

Decompression alone
Procedure/Surgery
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).
Decompression with extended fusion
Procedure/Surgery
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.

Treatment groups

192 Participants

are divided into 2 treatment groups

Group A: Decompression aloneExperimental treatment 1 intervention

Group B: Decompression with extended fusionActive comparator 1 intervention

Trial outcomes

Primary outcomes

Oswestry Disability Index (ODI): Change in percent

Improvement in the ODI score of a minimum of 30% from baseline (dichotomized variable: yes / no (yes = improved 30% or more, no = improved less than 30%)). The ODI is a questionnaire examin the level of disability based on 10 everyday activities of daily living. Each item consists of 6 statements which are scored from 0 to 5, with 0 indicating the least disability and 5 the highest level of disability. The total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability.

Time frame

From enrollment to five years postoperatively (main endpoint is two years after surgery, but ODI will also be assessed before surgery, 3 months, one- and five years postoperatively)

Secondary outcomes

Oswestry Disability Index (ODI): Continuous

Change in ODI from baseline (continuous variable)

Time frame

From enrollment to five years postoperatively (main endpoint is two years after surgery, but ODI will also be assessed before surgery, 3 months, one- and five years postoperatively)

Numeric Rating Scale leg pain (NRS leg pain)

Change in NRS leg pain from baseline. The NRS is a 11-point numeric scale (patient reported) ranging from '0' (e.g. "no pain") to '10' (e.g. "worst possible pain")

Time frame

From enrollment to five years postoperatively (main endpoint is two years after surgery, but NRS leg pain will also be assessed before surgery, 3 months, one- and five years postoperatively)

Numeric Rating Scale back pain (NRS back pain)

Change in NRS back pain from baseline. The NRS is a 11-point numeric scale (patient reported) ranging from '0' (e.g. "no pain") to '10' (e.g. "worst possible pain").

Time frame

From enrollment to five years postoperatively (main endpoint is two years after surgery, but NRS back pain will also be assessed before surgery, 3 months, one- and five years postoperatively)

Global perceived effect (GPE)

The GPE scale asks the participant to rate, on a 7 point Likert scale, how much their condition has improved or deteriorated. GPE 1-2 defined as success (completely recovered (1), much better (2)), GPE 3-5 defined as no change (somewhat better (3), no change (4), somewhat worse (5)), GPE 6-7 defined as worsening (much worse (6), worse than ever (7))

Time frame

From three months after surgery to five years postoperatively (main endpoint is two years after surgery, but GPE will also be assessed 3 months, one- and five years postoperatively)

Other outcomes

Adverse Events of special interest (AESI) and Serious Adverse Events (SAEs)

Safety assessments: Incidence of adverse events of special interest (AESI) and serious AE (SAEs)

Time frame

During the whole study period (five years)

Cost-effectiveness

Change in the EQ-5D-5L, hospital costs, community costs including sick leave, co-interventions (pharmacological and non-pharmacological).

Time frame

During the whole study period (five years)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oslo University Hospital

Lead sponsor

Sykehuset Innlandet HF

Collaborator

University Hospital of North Norway

Collaborator

Source ClinicalTrials.gov

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