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CompletedNCT03427281Updated Jan 27, 2023

Postoperative Bracing Patterns After Lumbar Surgery

An interventional study of questionnaire in Lumbar Spine Degeneration, Arthrosis; Spine and Surgery, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2023-01-27.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Not applicable
Sex
All
01

Study summary

A variety of postoperative bracing are routinely applied after spinal procedures but there are limited data regarding their efficacy, especially with the increasing use of internal fixation.Currently, no data are available regarding the use of postoperative braces in Belgium. Bracing is sometimes considered after lumbar surgery for degenerative conditions. All neurosurgeons and orthopedical surgeons in Belgium will be questioned to assess the patterns of postoperative bracing use after lumbar surgery.

Read the 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.

02

Conditions studied

  • Lumbar Spine Degeneration
  • Arthrosis; Spine
  • Surgery

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Orthopaedic surgeon or neurosurgeon in Belgium

Exclusion criteria

Exclusion Criteria:

  • N/A
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
97 participants (actual)

Study arms

  • Experimental
    Cohort: Belgian orthopaedic surgeons & neurosurgeon

    Behavioral: questionnaire

Interventions

  • Behavioralquestionnaire

    questionnaire to assess the patterns of postoperative bracing use by spinal surgeons in Belgium

05

What researchers measure

Primary outcomes

  1. Whether or not surgeons typically immobilize patients after specific spinal surgical procedures

    yes/no

    Time frame: 2 months

  2. Duration to prescribe a spinal orthosis after specific spinal surgical procedures

    \< 3 weeks, 3-8 weeks, 2-4 months, or \> 4 months

    Time frame: 2 months

  3. Rationale to prescribe a spinal orthosis after specific spinal surgical procedures

    to increase fusion rate, to improve pain, and/or to slow down the patient

    Time frame: 2 months

  4. Type of spinal orthosis prescribed after specific spinal surgical procedures

    lumbar corset, off the shelf lumbosacral orthosis, and/or costum molded lumbosacral orthosis

    Time frame: 2 months

06

Study locations

1 site
  • UZ/KU Leuven
    Leuven, Vlaams Brabant 3000, Belgium
07

References and documents

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. PubMed 18790685 ↗
  • 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. PubMed 30488116 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03427281
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, Hasselt University
Responsible party
Sponsor
First posted
Feb 9, 2018
Start date
Jan 10, 2018
Primary completion
Mar 30, 2018
Completion
Mar 30, 2018
Last update
Jan 27, 2023

Study contacts

Bart Depreitere, PhD, MD
principal investigator · Universitaire Ziekenhuizen KU Leuven
Thijs Swinnen, MSc
principal investigator · Universitaire Ziekenhuizen KU Leuven
Tinne Thys, MSc
principal investigator · Universitaire Ziekenhuizen KU Leuven
Wim Dankaerts, PhD, PT
principal investigator · KU Leuven
Simon Brumagne, PhD, PT
principal investigator · KU Leuven
Peter Van Wambeke, MD
principal investigator · Universitaire Ziekenhuizen KU Leuven
Lieven Moke, PhD, MD
principal investigator · Universitaire Ziekenhuizen KU Leuven
Sebastiaan Schelfaut, MD
principal investigator · Universitaire Ziekenhuizen KU Leuven
Ann Spriet, PT
principal investigator · Universitaire Ziekenhuizen KU Leuven
Lotte Janssens, PhD, PT
principal investigator · Hasselt University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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