Instr. vs. Non-instr. Posterolateral Spinal Fusion in Patients With Spinal Stenosis and Degenerative Listhesis

NCT04166981 | Completed DMC

• 1 other identifier: S-20160107
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine, in patients with grade 1 degenerative spondylolisthesis with spinal stenosis, if decompression and lumbar spinal fusion with, or without supplementary pedicle screw fixation yields an improved patient reported outcome.

Conditions

Spinal Stenosis; Spondylolisthesis Degenerative; Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index(ODI)

  A disease specific measure of physical disability in an index score ranging from 0-100, 0 being the best possible outcome and 100 being the worst. Comparing the effectiveness of the two arms.

  2 years after surgery

Secondary Outcomes (4)

• Achieved solid posterolateral fusion

  CT-scans 1 year after surgery

• Change in sagittal balance, effect on outcome.

  Pre operative, 1 and 2 years after surgery

• European Quality of life - 5 Dimensions (EQ-5D)

  preoperative, 3, 12 and 24 months after surgery

• Difference in cost-effectiveness between instrumented versus non-instrumented fusion.

  2 years after surgery.

Other Outcomes (2)

• Zurich Claudication Questionnaire

  Preoperative, 1 and 2 years after surgery.

• NRS score for leg- and back pain.

  Properative, 1 and 2 years after surgery.

Study Arms (2)

Non-instrumented arm

ACTIVE COMPARATOR

Decompression with concomitant non-instrumented posterolateral fusion with autologous(obtained from the decompression) and allogenic bone graft.

Procedure: Non-instrumented posterolateral spine fusion.

Instrumented arm

EXPERIMENTAL

Decompression with concomitant instrumented posterolateral fusion with autologous(obtained from the decompression) and allogenic bone graft and supplementary pedicle screw fixation.

Procedure: Instrumented posterolateral spine fusion.

Interventions

Instrumented posterolateral spine fusion. PROCEDURE

Posterolateral fusion with autologous and allogenic bone graft with supplementary pedicle screw fixation.

Also known as: Decompression on affected level

Instrumented arm

Non-instrumented posterolateral spine fusion. PROCEDURE

Posterolateral fusion with autologous and allogenic bone graft.

Also known as: Decompression on affected level

Non-instrumented arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Lumbar Spinal stenosis, with neurogenic claudication, radicular pain and,
• Confirmatory MRI scan showing lumbar spinal stenosis on 1-2 levels from L1-S1
• Standing X-ray showing grade 1 spondylolisthesis on one level
• Age 60 and above
• Symptom duration of 3+ months

You may not qualify if:

• Stenosis caused by herniated disc
• Prior vertebral compression fracture in the affected segments
• Active malignancy
• Current fracture, infection og deformity of the spine
• Stenosis on 3 or more levels
• MMSE test score below 24
• Neuromuscular disease
• Obligatory peroral steroid treatment
• ASA grade 3 or more.

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead

Study Sites (1)

Spine Center of Southern Denmark

Middelfart, 5500, Denmark

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Andreas K Andresen, MD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcome assessors are blinded for treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 18, 2019
• Study Start: January 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication of articles and ending after 36 months.
• Access Criteria: Researchers who provide a sound methodological proposal. Proposals should be addressed to andreas.andresen@rsyd.dk

Locations

DK (1)