NCT02773134

The Early Impact of Postoperative Bracing on Pain and Quality of Life Following Posterior Instrumented Fusion for Lumbar Degenerative Conditions

The Early Impact of Postoperative Bracing on Pain and Quality of Life Following Posterior Instrumented Fusion for Lumbar Degenerative Conditions: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Academic / Other
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Degenerative Conditions

Interventions

Type	Name	Description
OTHER	Brace 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.
OTHER	Control 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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-05-16
• Last updated: 2025-11-26