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

Instrumented vs. Non-instrumented Posterolateral Spinal Fusion in Patients With Spinal Stenosis and Degenerative Listhesis

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.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis; Spinal Fusion; Spondylolisthesis Degenerative
• Intervention / Treatment: Procedure: Non-instrumented posterolateral spine fusion.; Procedure: Instrumented posterolateral spine fusion.

Detailed Description

Lumbar spinal stenosis (LSS) is a common disease with a large impact on the quality of life of the patient. LSS is defined as narrowing of the spinal canal, nerve root canal or intervertebral foramina. Spinal stenosis is caused by degenerative changes in the lumbar spine, including thickening of the ligamentum flavum, osteophyte formation and disc protrusion. Pain is worse with standing upright and with exercise, and relieved with spine flexion or sitting down.

In the Wakayama Spine Study, investigators found radiographic severe spinal stenosis, defined as narrowing of more than two-thirds of the spinal canal area, in 30,4% of all patients, but only 17,5% were symptomatic.

Many of the patients suffering from LSS are pensioners, with an average age of 65 years. With current changes in demographics and the aging global population it is estimated that prevalence of LSS will increase to nearly 60% by 2025.

In a Danish epidemiological study, degenerative spondylolisthesis was found in 2,7% of men and 8,4% of women above 50 years. Every year, more than 3500 patients aged 60 and above are referred to Center of Spine Surgery Middelfart for LSS. According to the national Danish surgical spine database, DaneSpine, 7936 patients with LSS had surgery during a period from 2009-2013.

Patients suffering from LSS and instability are treated with decompression and posterolateral spinal fusion with or without instrumentation. According to DaneSpine, this group of patients showed improvements on both physical and psychological parameters. In countries outside of Scandinavia, these patients are usually treated with decompression and posterolateral spinal fusion with supplementary pedicle screw fixation. Instrumentation with pedicle screws and rods provides an internal splint, preventing motion during fusion healing. The fusion rate in non-instrumented arthrodesis is reported to be as low as 30-45% In contrast the fusion rate with instrumented arthrodesis have been reported to be above 80%. Although some studies have shown similar outcomes after decompression with or without instrumentation, long-term follow up has shown that a solid fusion improves clinical outcome.

In recent retrospective studies, the spinal sagittal balance, specifically the sagittal vertical axis (SVA) has been shown to affect the outcome of patients undergoing laminectomy. Decompression surgery has been shown to improve sagittal balance in patients with a preoperative imbalance, compared to patients treated with rehabilitation. The preoperative sagittal imbalance has not been shown to significantly affect health-related quality of life(HRQoL)outcomes although a residual imbalance after decompression is related to a poorer outcome. No prospective studies to our knowledge have compared the sagittal balance and outcomes in patients with spinal stenosis and spondylolisthesis, treated with decompression and spinal fusion with or without supplemental pedicle screw fixation.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Middelfart, Denmark, 5500
    • Spine Center of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-instrumented arm; Decompression with concomitant non-instrumented posterolateral fusion with autologous(obtained from the decompression) and allogenic bone graft.	Procedure: Non-instrumented posterolateral spine fusion.; Posterolateral fusion with autologous and allogenic bone graft.; Other Names: Decompression on affected level
Experimental: Instrumented arm; 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.; Posterolateral fusion with autologous and allogenic bone graft with supplementary pedicle screw fixation.; Other Names: Decompression on affected level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achieved solid posterolateral fusion	Fine cut CT-scans, evaluated by 3 observers to determine if solid posterolateral fusion is achieved.	CT-scans 1 year after surgery
Change in sagittal balance, effect on outcome.	Lateral scoliosis X-rays obtained pre operatively and after 1 and 2 years.	Pre operative, 1 and 2 years after surgery
European Quality of life - 5 Dimensions (EQ-5D)	Changes in quality of life in the study groups, Obtained preoperatively, after 3 months, 1 year and 2 years. Scores range between -0.6 to 1.0 where 1 is perfect health.	preoperative, 3, 12 and 24 months after surgery
Difference in cost-effectiveness between instrumented versus non-instrumented fusion.	Additional cost of instrumentation, incidence of revision surgery and treatment effectiveness, measured by health state utilities. Measured in Quality adjusted Life years(QaLY) and cost of surgery measured in American dollars.	2 years after surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zurich Claudication Questionnaire	Disease specific patient reported outcome, to measure changes in function. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability.	Preoperative, 1 and 2 years after surgery.
NRS score for leg- and back pain.	Patient reported leg and back pain. Obtained preoperatively, after 3 months, 1 year and 2 years. Score is 0-100, the score increases with worsening pain.	Properative, 1 and 2 years after surgery.

Collaborators and Investigators

• Sponsor: Spine Centre of Southern Denmark
• Investigators: Principal Investigator: Andreas K Andresen, MD, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Constriction, Pathologic; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: S-20160107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All individual patient data that underlies the results reported in this article, after deidentification. (texts, tables, figures)
• IPD Sharing Time Frame: 6 months after publication of articles and ending after 36 months.
• IPD Sharing Access Criteria: Researchers who provide a sound methodological proposal. Proposals should be addressed to andreas.andresen@rsyd.dk
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No