Postoperative Bracing Patterns After Lumbar Surgery

January 26, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

Postoperative Bracing Patterns After Lumbar Surgery for Degenerative Conditions in Belgium

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ/KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Orthopaedic surgeon or neurosurgeon in Belgium

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • KU/UZ Leuven S60109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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