NCT02348645

Brief Summary

The purpose of this study is to assess the feasibility of a full-scale multicenter randomized, controlled trial comparing the effectiveness of two surgical treatments for a condition associated with lumbar spinal stenosis called degenerative lumbar spondylolisthesis. Both treatments are currently used, but individual surgeons use different selection criteria for each treatment and use the procedures at different rates. The two procedures are decompression with fusion (the most common surgical procedure for spondylolisthesis) and midline-sparing decompression alone (which is also a standard treatment, but is not as widely used for treating spondylolisthesis). The investigators plan to collect the evidence on the following:

  1. 1.The feasibility of the trial protocol, and
  2. 2.Preliminary data on the effectiveness of each treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

7.9 years

First QC Date

September 9, 2014

Last Update Submit

November 4, 2022

Conditions

Spinal StenosisSpondylolisthesis

Keywords

Pilot projectsFeasibility studiesIntervention studiesOrthopedicsOrthopedic ProceduresNeurosurgical ProceduresNeurosurgerySpineSpinal FusionSpondylodesisSpondylosyndesisLaminectomyForaminotomyDecompression, surgicalLow Back PainQuality of Life

Outcome Measures

Primary Outcomes (10)

  • Number of patients recruited

    1 year

  • Number of eligible patients

    1 year

  • Reasons for refusal to consent

    1 year

  • Proportion of patients who adhere to randomized allocation

    2 years

  • Number of patients refusing to consent due to blinding

    1 year

  • Blinding status

    Patient's assessment of which treatment they received

    1.5 months post-surgery

  • Oswestry Disability Index (ODI)

    10-item patient-reported questionnaire measuring disability related to low back pain. Each item has six response options ranging from 0 to 5; the responses are summed and rescaled so 0 indicates no disability and 100 indicates extreme disability.

    6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery

  • Proportion of patients who receive randomized allocation

    2 years

  • Number of patients refusing to consent due to randomization

    1 year

  • Number, type and severity of adverse events

    End of hospital stay (average 6.5 days post-surgery)

Secondary Outcomes (6)

  • Short-Form 12 scores: Physical Function, Bodily Pain, Physical Component Summary

    Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery

  • Euro-QoL health utility index

    Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery

  • Patient Health Questionnaire-9 score

    Baseline

  • Costs incurred by patients

    monthly from 1.5 to 12 months post-surgery; 24 months post-surgery

  • Hospital cost

    End of hospital stay (average 6.5 days post-surgery)

  • +1 more secondary outcomes

Study Arms (2)

Decompression with fusion

ACTIVE COMPARATOR

Spinal decompression surgery with instrumented spinal fusion

Procedure: Spinal fusionProcedure: Spinal decompression

Decompression alone

ACTIVE COMPARATOR

Midline-sparing spinal decompression alone

Procedure: Spinal decompression

Interventions

Spinal fusionPROCEDURE
Decompression with fusion
Spinal decompressionPROCEDURE
Decompression aloneDecompression with fusion

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients deemed to be surgical candidates with focal (1-2 level) lumbar spinal stenosis (LSS) and associated stable degenerative spondylolisthesis with the following characteristics:
  • a clinical history of back, buttock and leg pain with walking or standing that is improved when lying, sitting or bending forward
  • a clinical history of leg symptoms that are greater than or equal to back symptoms with walking or standing, and
  • greater than 6 months of symptoms with failed conservative care
  • aged 50 or over
  • sufficient fluency in English or French to provide informed consent and complete questionnaires with or without the need of an interpreter

You may not qualify if:

  • Greater than 25% listhesis or spinal instability as demonstrated by motion (\>5mm of translation) on flexion extension radiographs or non-loaded (MRI/CT or supine x-rays) to loaded imaging (standing radiograph)
  • Presence of kyphosis (\>0 degrees at the affected level or globally), degenerative scoliosis (\>10 degree using the Cobb method) with rotatory or lateral listhesis on preoperative x-rays
  • Clinical history of osteoporotic fracture or chronic oral steroid use
  • Previous posterior lumbar spinal surgery (excluding prior microdiscectomy)
  • Patients who have evidence of neurological disorders that affect physical function (e.g. peripheral neuropathy), neuromuscular disorders (e.g. multiple sclerosis, Parkinson's etc.) or systemic illness (e.g. inflammatory arthritis) that affects physical function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Foothills Medical Centre

Calgary, Alberta, T2N 2N9, Canada

Location

Mackenzie Health Sciences Centre

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Spinal StenosisSpondylolisthesisLow Back Pain

Interventions

Spinal FusionLaminectomy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosisBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ArthrodesisOrthopedic ProceduresSurgical Procedures, OperativeTherapeuticsDecompression, SurgicalNeurosurgical Procedures

Study Officials

  • Yoga Raja Rampersaud, MD FRCSC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Anthony Perruccio, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

January 28, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

CA(8)