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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHamilton Health Sciences Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Single-level lumbar instrumented postero-lateral fusion from L2-L5

Life expectancy greater than 2 years

Disqualifiers

Previous lumbar surgery

Spine tumour/cancer

Documented osteoporosis

High grade (3 or 4) spondylolisthesis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lumbar brace

    Device

    3 months of lumbar brace wear

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: BraceExperimental treatment 1 intervention
Group B: No braceNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of enrolment

Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.

Time frame
12 months
2

Rate of study completion

Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.

Time frame
12 months

Secondary outcomes

1

Lumbar bone fusion

Status of bone fusion assessed radiologically by CT scan

Time frame
12 months
2

Functional Status

The Oswestry Disability Index

Time frame
3 months, 6 months, 12 months
3

Pain Status

Visual analog scale (0, no pain to 10, worst pain)

Time frame
3 months, 6 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hamilton Health Sciences Corporation

Lead sponsor

McMaster University

Collaborator

DJO Incorporated

Collaborator

Stryker Canada LP

Collaborator