- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03427281
Postoperative Bracing Patterns After Lumbar Surgery
Postoperative Bracing Patterns After Lumbar Surgery for Degenerative Conditions in Belgium
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects: all neurosurgeons and orthopedical surgeons in Belgium
Outcomes: The content of the questionnaire is based on a previously conducted study in the USA, cfr. "Bible, J. E., Biswas, D., Whang, P. G., Simpson, A. K., Rechtine, G. R., Grauer, J. N. (2009). Postoperative bracing after spine surgery for degenerative conditions: a questionnaire study. The Spine Journal, 9(4), p. 309-316." Permission to use this questionnaire was received from the corresponding author.
More specifically, a single-page questionnaire will be distributed to all spinal surgeons affiliated to the Spine Society Belgium. The questionnaire will focus on whether surgeons typically immobilize patients after specific spinal procedures, the type of orthosis used, the duration of treatment, and the rationale for bracing.
Data analysis: Both descriptive and inferential statistical methods will be used. The study Frequencies and percentages for categorical variables will be calculated. Chi-square analysis will be used. Significance level will be set at 0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vlaams Brabant
-
Leuven, Vlaams Brabant, Belgium, 3000
- UZ/KU Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Orthopaedic surgeon or neurosurgeon in Belgium
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort: Belgian orthopaedic surgeons & neurosurgeon
|
questionnaire to assess the patterns of postoperative bracing use by spinal surgeons in Belgium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whether or not surgeons typically immobilize patients after specific spinal surgical procedures
Time Frame: 2 months
|
yes/no
|
2 months
|
Duration to prescribe a spinal orthosis after specific spinal surgical procedures
Time Frame: 2 months
|
< 3 weeks, 3-8 weeks, 2-4 months, or > 4 months
|
2 months
|
Rationale to prescribe a spinal orthosis after specific spinal surgical procedures
Time Frame: 2 months
|
to increase fusion rate, to improve pain, and/or to slow down the patient
|
2 months
|
Type of spinal orthosis prescribed after specific spinal surgical procedures
Time Frame: 2 months
|
lumbar corset, off the shelf lumbosacral orthosis, and/or costum molded lumbosacral orthosis
|
2 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Peter Van Wambeke, MD, Universitaire Ziekenhuizen KU Leuven
- Principal Investigator: Bart Depreitere, PhD, MD, Universitaire Ziekenhuizen KU Leuven
- Principal Investigator: Wim Dankaerts, PhD, PT, KU Leuven
- Principal Investigator: Simon Brumagne, PhD, PT, KU Leuven
- Principal Investigator: Lieven Moke, PhD, MD, Universitaire Ziekenhuizen KU Leuven
- Principal Investigator: Sebastiaan Schelfaut, MD, Universitaire Ziekenhuizen KU Leuven
- Principal Investigator: Thijs Swinnen, MSc, Universitaire Ziekenhuizen KU Leuven
- Principal Investigator: Tinne Thys, MSc, Universitaire Ziekenhuizen KU Leuven
- Principal Investigator: Ann Spriet, PT, Universitaire Ziekenhuizen KU Leuven
Publications and helpful links
General Publications
- Bible JE, Biswas D, Whang PG, Simpson AK, Rechtine GR, Grauer JN. Postoperative bracing after spine surgery for degenerative conditions: a questionnaire study. Spine J. 2009 Apr;9(4):309-16. doi: 10.1016/j.spinee.2008.06.453. Epub 2008 Sep 14.
- Bogaert L, Van Wambeke P, Thys T, Swinnen TW, Dankaerts W, Brumagne S, Moke L, Peers K, Depreitere B, Janssens L. Postoperative bracing after lumbar surgery: a survey amongst spinal surgeons in Belgium. Eur Spine J. 2019 Feb;28(2):442-449. doi: 10.1007/s00586-018-5837-0. Epub 2018 Nov 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KU/UZ Leuven S60109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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