To Brace or Not to Brace for Single Level Lumbar Fusion P... | NCT03439228

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

NCT03439228

Sponsor

Hamilton Health Sciences Corporation

Status

Recruiting

Last Update Posted

Oct 23, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Lumbar Spondylosis
Fusion of Spine

Interventions

Lumbar brace

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2018Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Feb 14, 2018

First Submission Date that Met QC Criteria

Feb 14, 2018

First Posted Date

Feb 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2024

Last Update Posted Date

Oct 23, 2024Actual

Name	Class
McMaster University	OTHER
DJO Incorporated	INDUSTRY
Stryker Canada LP	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brace	Experimental	Lumbar brace wear prescribed for 3 months post-operation	Device: Lumbar brace
No brace	No Intervention	No lumbar brace prescribed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lumbar brace	Device	3 months of lumbar brace wear	Brace

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of enrolment	Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.	12 months
Rate of study completion	Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Lumbar bone fusion	Status of bone fusion assessed radiologically by CT scan	12 months
Functional Status	The Oswestry Disability Index

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amanda Martyniuk, MSc	Contact	905-521-2100	44155	martynia@mcmaster.ca

Overall Officials

Name	Affiliation	Role
Aleksa Cenic, MSc, MD, FRCSC	Hamilton Health Sciences and McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton General Hospital	Recruiting	Hamilton	Ontario	L8L 2X2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055009	Spondylosis

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided