Postoperative Bracing Patterns After Lumbar Surgery

NCT ID: NCT03427281

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2018-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lumbar Spine Degeneration Arthrosis; Spine Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

the investigator is blinded for the identity of the participating surgeons in the questionnaire

Study Groups

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Cohort: Belgian orthopaedic surgeons & neurosurgeon

Group Type EXPERIMENTAL

questionnaire

Intervention Type BEHAVIORAL

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

Interventions

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questionnaire

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Orthopaedic surgeon or neurosurgeon in Belgium

Exclusion Criteria

* N/A
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bart Depreitere, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Thijs Swinnen, MSc

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Tinne Thys, MSc

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Wim Dankaerts, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Simon Brumagne, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Peter Van Wambeke, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Lieven Moke, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Sebastiaan Schelfaut, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Ann Spriet, PT

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Lotte Janssens, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

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UZ/KU Leuven

Leuven, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 18790685 (View on PubMed)

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.

Reference Type RESULT
PMID: 30488116 (View on PubMed)

Other Identifiers

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KU/UZ Leuven S60109

Identifier Type: -

Identifier Source: org_study_id

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