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To Brace or Not to Brace for Single Level Lumbar Fusion Pilot (BRACE Pilot)

Primary Purpose

Lumbar Spondylosis, Fusion of Spine

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lumbar brace
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spondylosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Single-level lumbar instrumented postero-lateral fusion from L2-L5
  • Life expectancy greater than 2 years

Exclusion Criteria:

  • Previous lumbar surgery
  • Spine tumour/cancer
  • Documented osteoporosis
  • High grade (3 or 4) spondylolisthesis

Sites / Locations

  • Hamilton General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brace

No brace

Arm Description

Lumbar brace wear prescribed for 3 months post-operation

No lumbar brace prescribed

Outcomes

Primary Outcome Measures

Rate of enrolment
Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.
Rate of study completion
Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.

Secondary Outcome Measures

Lumbar bone fusion
Status of bone fusion assessed radiologically by CT scan
Functional Status
The Oswestry Disability Index
Pain Status
Visual analog scale (0, no pain to 10, worst pain)

Full Information

First Posted
February 14, 2018
Last Updated
September 20, 2023
Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University, DJO Incorporated, Stryker Canada LP
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1. Study Identification

Unique Protocol Identification Number
NCT03439228
Brief Title
To Brace or Not to Brace for Single Level Lumbar Fusion Pilot
Acronym
BRACE Pilot
Official Title
To Brace or Not to Brace for Single Level Lumbar Fusion: A Pilot Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University, DJO Incorporated, Stryker Canada LP

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis (non-traumatic) is variable between surgeons. Some surgeons prefer to prescribe a brace and others do not. There is a lack of guidelines and evidence to support either treatment option. The purpose of this study is to assess feasibility and collect preliminary data to conduct a larger, definitive trial to provide evidence as to whether prescribing a brace or not results in better or equal outcomes. Imaging by CT scan, one year after surgery, will be used to analyze bone fusion (healing), and functional and pain scores from patients during their recovery will be compared to identify differences between patients who wore a brace and those who did not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spondylosis, Fusion of Spine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brace
Arm Type
Experimental
Arm Description
Lumbar brace wear prescribed for 3 months post-operation
Arm Title
No brace
Arm Type
No Intervention
Arm Description
No lumbar brace prescribed
Intervention Type
Device
Intervention Name(s)
Lumbar brace
Intervention Description
3 months of lumbar brace wear
Primary Outcome Measure Information:
Title
Rate of enrolment
Description
Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.
Time Frame
12 months
Title
Rate of study completion
Description
Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Lumbar bone fusion
Description
Status of bone fusion assessed radiologically by CT scan
Time Frame
12 months
Title
Functional Status
Description
The Oswestry Disability Index
Time Frame
3 months, 6 months, 12 months
Title
Pain Status
Description
Visual analog scale (0, no pain to 10, worst pain)
Time Frame
3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Single-level lumbar instrumented postero-lateral fusion from L2-L5 Life expectancy greater than 2 years Exclusion Criteria: Previous lumbar surgery Spine tumour/cancer Documented osteoporosis High grade (3 or 4) spondylolisthesis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Martyniuk, MSc
Phone
905-521-2100
Ext
44155
Email
martynia@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksa Cenic, MSc, MD, FRCSC
Organizational Affiliation
Hamilton Health Sciences and McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Martyniuk, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Brace or Not to Brace for Single Level Lumbar Fusion Pilot

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