Lumbar Degenerative Conditions
Conditions
Keywords
Post-operative Bracing, Rigid Lumbosacral Orthosis, Posterior Spine Fusion, Quality of Life, Lumbar Degenerative Conditions
Brief summary
Braces are commonly prescribed after posterior spinal instrumented fusion (PSIF) in patients with lumbar degenerative conditions with the aim of improving pain relief and quality of life. However, there is a lack of evidence on the indication for postoperative bracing, as surgeons choose to use braces mainly based on their experience and training. The aim of this study is to investigate whether wearing a brace after PSIF can improve pain relief and quality of life (QOL) 6 weeks and 3 months after surgery.
Interventions
OTHERBrace Group
All eligible patients will undergo a Posterior Spine Instrumented Fusion (PSIF) with the use of autologous local and iliac crest bone graft, and all pedicle screw instrumentation. A deep wound drain will be placed in all patients for 48 hours. All patients will complete the Oswestry Disability Index (ODI) questionnaire, the SF-12v2 General Health Survey and the Visual Analogue Scale (VAS) for back pain at baseline visit (preoperatively) and post-operatively at 6 weeks and 3 months follow up. Clinical and radiographic assessments will be performed by independent blinded observers not involved in patient care.
OTHERControl Group
All eligible patients will undergo a Posterior Spine Instrumented Fusion (PSIF) with the use of autologous local and iliac crest bone graft, and all pedicle screw instrumentation. A deep wound drain will be placed in all patients for 48 hours. Bracing will not be prescribed postoperatively for this group. All patients will the Oswestry Disability Index (ODI) questionnaire, the SF-12v2 General Health Survey and the Visual Analogue Scale (VAS) for back pain at baseline visit (pre-operatively) and post-operatively at 6 weeks and 3 months follow up. Clinical and radiographic assessments will be performed by independent blinded observers not involved in patient care.
Sponsors
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
* Patients with degenerative lumbar spine disease (degenerative spondylolisthesis, spinal stenosis, or degenerative disc disease); * Patients scheduled for an elective posterior spinal fusion.
Exclusion criteria
* Patients with obesity (BMI \> 35kg/m2).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oswestry Disability Index (ODI) score following the surgery. | Baseline, 6 weeks postoperatively, 3 months postoperatively | The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SF-12v2 Physical Component Score (PCS) | Baseline, 6 weeks postoperatively, 3 months postoperatively. | SF-12v2® and SF-8™ Health Surveys measure the same eight health domains, and each survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. |
| Change in SF-12v2 Mental Component Score (MCS) | Baseline, 6 weeks postoperatively, 3 months postoperatively. | SF-12v2® Health Survey measures eight health domains and provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. |
| Change in Visual Analog Scale (VAS) for back pain | Baseline, 6 weeks postoperatively, 3 months postoperatively. | The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. |
Outcome results
None listed