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

Not Applicable

Recruiting

• Conditions: Lumbar Spondylosis; Fusion of Spine
• Interventions: Device: Lumbar brace

• Registration Number: NCT03439228
• Lead Sponsor: Hamilton Health Sciences Corporation

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 available

Study Timeline

• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-02-14
• Study First Posted: 2018-02-20
• Study Start: 2018-07-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brace	Lumbar brace	Lumbar brace wear prescribed for 3 months post-operation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Functional Status	3 months, 6 months, 12 months	The Oswestry Disability Index
Pain Status	3 months, 6 months, 12 months	Visual analog scale (0, no pain to 10, worst pain)
Lumbar bone fusion	12 months	Status of bone fusion assessed radiologically by CT scan

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada