Lumbar Brace for Lumbar Spondylosis

(BRACE Pilot Trial)

Overseen By Amanda Martyniuk, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hamilton Health Sciences Corporation

Disqualifiers: Previous lumbar surgery, Spine cancer, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is wearing a lumbar brace generally safe for humans?

The available research does not provide specific safety data on lumbar braces for lumbar spondylosis, but it does discuss safety concerns related to spinal surgeries and implants, such as screw loosening and reoperation rates. These findings suggest that while surgical interventions have associated risks, there is no direct evidence of safety issues specifically related to wearing lumbar braces. ^{1 2 3 4 5}

How does the lumbar brace treatment for lumbar spondylosis differ from other treatments?

The lumbar brace treatment for lumbar spondylosis is unique because it provides physical support to the spine, reducing motion and stress on the affected area, which can help relieve symptoms and facilitate recovery. Unlike medications or surgeries, this treatment focuses on stabilizing the spine externally, which can be particularly beneficial for those with motion-segment instability or stress fractures. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Lumbar brace for Lumbar Spondylosis?

Research suggests that lumbar braces can help reduce spinal stress and support the spine in a stable position, which may be beneficial for conditions involving instability or low back pain. However, the effectiveness of lumbar braces specifically for lumbar spondylosis is not clearly established in the available studies. ^{7 8 10 11 12}

Who Is on the Research Team?

Aleksa Cenic, MSc, MD, FRCSC

Principal Investigator

Hamilton Health Sciences and McMaster University

Are You a Good Fit for This Trial?

This trial is for individuals with a life expectancy over 2 years who are undergoing single-level lumbar fusion surgery between the L2-L5 vertebrae due to non-traumatic spondylosis. It's not suitable for those with previous lumbar surgeries, spine tumors/cancer, osteoporosis, or high-grade spondylolisthesis.

Inclusion Criteria

Life expectancy greater than 2 years

I had a specific spine surgery involving screws and rods between L2 and L5.

Exclusion Criteria

I have a severe (grade 3 or 4) spinal condition.

I have had surgery on my lower back.

I have been diagnosed with osteoporosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo single-level lumbar fusion surgery with or without a lumbar brace prescribed for 3 months post-operation

3 months

Regular follow-up visits as per surgical protocol

Follow-up

Participants are monitored for functional status, pain status, and bone fusion through CT scans and disability index assessments

12 months

Visits at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Lumbar brace

Trial Overview The study is testing whether wearing a lumbar brace after single-level lumbar fusion surgery affects bone healing and recovery. Patients will be monitored through CT scans one year post-surgery and their pain and functional scores will be compared.

How Is the Trial Designed?

Group I: Brace Experimental Treatment 1 Intervention

Lumbar brace wear prescribed for 3 months post-operation

Group II: No brace Active Control 1 Intervention

No lumbar brace prescribed

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

DJO Incorporated

Industry Sponsor

Trials

16

Recruited

1,300+

Stryker Canada LP

Industry Sponsor

Trials

4

Recruited

180+

Published Research Related to This Trial

The Boston brace was found to distract the lumbar spine and correct frontal deformity in adolescents with idiopathic scoliosis, but it significantly reduced the natural curvature of the lumbar spine (lumbar lordosis).

Despite its effects on frontal alignment, the brace did not significantly improve the rotation of the apical vertebra or spinal detorsion, indicating that a more effective 3-D corrective orthosis is still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[3-D study of the immediate effect of the Boston brace on the scoliotic lumbar spine]. Labelle, H., Dansereau, J., Bellefleur, C., et al.[2009]

Postoperative bracing after surgical stabilization of thoracolumbar fractures is commonly used, with a median wear time of 13.3 weeks, but shows no significant benefits in pain relief, return to work, or functional improvement compared to not using a brace.

While bracing is associated with a lower rate of pseudoarthrosis (2.4% vs. 6.0%), it also has a higher overall complication rate (16.3% vs. 11.9%) and a greater loss of surgical correction, suggesting that the routine use of braces may need further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bracing After Surgical Stabilization of Thoracolumbar Fractures: A Systematic Review of Evidence, Indications, and Practices. Skoch, J., Zoccali, C., Zaninovich, O., et al.[2018]

For severe spinal instability, a Hohmann overbridging brace is essential for treatment, highlighting its importance in providing stability and support.

Milder cases of motion-segment instability can be effectively managed with elastic supports, while the Lindemann 2/3 semi-elastic brace is recommended for patients with osteoporosis or lumbosacral insufficiency, indicating tailored approaches based on the severity and specific conditions of low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bracing and supporting of the lumbar spine. Schroeder, S., Rössler, H., Ziehe, P., et al.[2017]

In a survey of 105 spinal surgeons in Belgium, 38% reported prescribing postoperative lumbar bracing, particularly after fusion surgeries (52% compared to 21% for non-fusion procedures), despite evidence suggesting no significant benefits in pain relief or fusion rates.

Surgeons primarily prescribed braces for pain alleviation (67%) and to improve fusion rates (42%), even though existing scientific literature does not support these beliefs, indicating a gap between practice and evidence-based guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative bracing after lumbar surgery: a survey amongst spinal surgeons in Belgium. Bogaert, L., Van Wambeke, P., Thys, T., et al.[2020]

A new variable lumbar orthosis has been developed that allows patients to adjust abdominal and lumbar support according to their changing needs, which is not available in current commercial options.

This orthosis has shown favorable results in a clinical setting for patients with low back pain, providing a tailored approach to support and immobilization based on the severity of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The variable lumbar orthosis: fabrication and guidelines for use. Basile, VJ., Goldstein, DF.[2008]

In a study of 466 patients with adolescent idiopathic scoliosis, the reoperation rates after spinal deformity surgery varied by technique, ranging from 4.5% for open anterior spinal fusion to 8.8% for posterior spinal fusion with hooks, indicating that while reoperations are necessary, they occur at relatively low rates.

The study identified common serious radiographic adverse events, such as rod breakage and proximal screw pullout, but found no significant differences in the incidence of these events across different surgical techniques, suggesting that all methods have similar safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. Flynn, JM., Betz, RR., O'Brien, MF., et al.[2021]

A review of 37 active and prospective clinical trials on lumbar spondylolisthesis (LS) indicates a significant trend towards using novel technologies, with nearly half of the trials (48.6%) focusing on innovative treatment methods such as 3D-printed titanium cages and interbody implants.

Patient-reported outcome measures (PROMs) are widely utilized in these trials, being included in 91.9% of studies, highlighting the importance of assessing patient experiences and outcomes in the management of LS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging innovations for lumbar spondylolisthesis management: a systematic review of active and prospective clinical trials. Harrison, DJ., Bhandarkar, AR., Durrani, S., et al.[2022]

The mortality rate following spinal surgery for degenerative lumbar disease is very low at 0.20%, indicating a high level of safety for these procedures.

Complication rates for different conditions were found to be 7.6% for lumbar canal stenosis, 8.5% for degenerative spondylolisthesis, and 3.5% for lumbar disc herniation, with reoperation rates of 8.1%, 8.0%, and 6.2% respectively, providing important information for patient counseling regarding surgical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systematic review of complications for proper informed consent(12)decompression or fixation surgery of the lumbar spine]. Takahashi, T., Hanakita, J., Watanabe, M., et al.[2018]

In a study of 230 patients with ankylosing spondylitis who underwent pedicle subtraction osteotomy (PSO) for thoracolumbar kyphosis, 33.5% experienced surgery-related complications, with 24.3% due to surgical/technical failures and 9.1% due to mechanical failures.

Despite the high complication rate, PSO resulted in significant improvement in the sagittal vertical axis, indicating that while effective for correcting kyphosis, careful monitoring and radiographic assessment are crucial to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic findings for surgery-related complications after pedicle subtraction osteotomy for thoracolumbar kyphosis in 230 patients with ankylosing spondylitis. Lee, KH., Kim, KT., Kim, YC., et al.[2020]

In a study of 19 patients undergoing lumbar spine stabilization with the Dynesys system, screw malposition was observed in a few cases, but it did not consistently lead to screw loosening or necessitate revision surgeries, indicating that some malpositions may not impact clinical outcomes significantly.

All patients showed improvement in pain and function scores after surgery, suggesting that the Dynesys system can be effective for lumbar stabilization, regardless of the navigation method used during implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screw loosening after posterior dynamic stabilization--review of the literature. Kocak, T., Cakir, B., Reichel, H., et al.[2022]

The custom-made hard lumbar-sacral orthosis (HO) was found to provide the greatest restriction of motion in the lumbar spine, reducing rotation and side bending by 58.3% and 63.6% compared to no orthosis, making it potentially the most effective option for conservative treatment of lumbar spondylolysis.

Among the soft lumbar-sacral orthoses, the Damen type elasticity corset (DC) was unique in providing significant restriction in flexion compared to no orthosis, indicating that different designs can offer varying levels of support for specific movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Type of Orthosis is Optimal for Conservative Treatment of Lumbar Spondylolysis?: A Biomechanical Analysis. Fujimoto, Y., Sakai, T., Sairyo, K.[2022]

Bracing significantly reduces the range of motion (ROM) in both the thoracic and lumbar spine during various activities, which may help alleviate stress on the vertebral pars interarticularis in adolescents with spondylolysis.

The study, involving five patients with an average age of 14.4 years, suggests that using a lumbar corset brace can relieve symptoms of spondylogenic back pain, potentially aiding athletes in returning to sports safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of corset bracing on 3D spine kinematics during ADL in children with Spondylolysis. Hays, C., Fehr, S., Liu, XC., et al.[2021]

Citations

1. France pubmed.ncbi.nlm.nih.gov

[3-D study of the immediate effect of the Boston brace on the scoliotic lumbar spine]. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Bracing After Surgical Stabilization of Thoracolumbar Fractures: A Systematic Review of Evidence, Indications, and Practices. [2018]

3. France pubmed.ncbi.nlm.nih.gov

Bracing and supporting of the lumbar spine. [2017]

4. Germany pubmed.ncbi.nlm.nih.gov

Postoperative bracing after lumbar surgery: a survey amongst spinal surgeons in Belgium. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The variable lumbar orthosis: fabrication and guidelines for use. [2008]

6. United States pubmed.ncbi.nlm.nih.gov

Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Emerging innovations for lumbar spondylolisthesis management: a systematic review of active and prospective clinical trials. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

[Systematic review of complications for proper informed consent(12)decompression or fixation surgery of the lumbar spine]. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Radiographic findings for surgery-related complications after pedicle subtraction osteotomy for thoracolumbar kyphosis in 230 patients with ankylosing spondylitis. [2020]

10. Czech Republic pubmed.ncbi.nlm.nih.gov

Screw loosening after posterior dynamic stabilization--review of the literature. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

What Type of Orthosis is Optimal for Conservative Treatment of Lumbar Spondylolysis?: A Biomechanical Analysis. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of corset bracing on 3D spine kinematics during ADL in children with Spondylolysis. [2021]