NCT03427281

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

January 27, 2023

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

January 26, 2018

Last Update Submit

January 26, 2023

Conditions

Lumbar Spine DegenerationArthrosis; SpineSurgery

Outcome Measures

Primary Outcomes (4)

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

    yes/no

    2 months

  • Duration to prescribe a spinal orthosis after specific spinal surgical procedures

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

    2 months

  • 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

    2 months

  • Type of spinal orthosis prescribed after specific spinal surgical procedures

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

    2 months

Study Arms (1)

Cohort: Belgian orthopaedic surgeons & neurosurgeon

EXPERIMENTAL
Behavioral: questionnaire

Interventions

questionnaireBEHAVIORAL

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

Cohort: Belgian orthopaedic surgeons & neurosurgeon

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Orthopaedic surgeon or neurosurgeon in Belgium

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ/KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 18790685BACKGROUND

  • 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.

    PMID: 30488116RESULT

MeSH Terms

Conditions

Osteoarthritis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Bart Depreitere, PhD, 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

  • Wim Dankaerts, PhD, PT

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Simon Brumagne, PhD, PT

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Peter Van Wambeke, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Lieven Moke, PhD, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Sebastiaan Schelfaut, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Ann Spriet, PT

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Lotte Janssens, PhD, PT

    Hasselt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
the investigator is blinded for the identity of the participating surgeons in the questionnaire
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 9, 2018

Study Start

January 10, 2018

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

January 27, 2023

Record last verified: 2020-02

Locations

BE(1)