Recruiting

Lumbar Fusion

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT03439228

Conditions

Lumbar Spondylosis

Fusion of Spine

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lumbar brace

Study Details

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.

Conditions

Lumbar Spondylosis

Fusion of Spine

Study ID

NCT03439228

Start date

Jul 16, 2018

Status verified date

Oct, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brace

Lumbar brace wear prescribed for 3 months post-operation

no intervention: No brace

No lumbar brace prescribed

Interventions

Lumbar brace

3 months of lumbar brace wear

Primary outcome measure

  • Rate of enrolment [ Time Frame: 12 months ]
  • Rate of study completion [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Oct 23, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2024-10-23.