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Postoperative Bracing Patterns After Lumbar Surgery

Sponsor
Hasselt University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03427281
Collaborator
Universitaire Ziekenhuizen Leuven (Other), KU Leuven (Other)
60
Enrollment
1
Location
1
Arm
10.7
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: questionnaire
 N/A

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,

    1. (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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
the investigator is blinded for the identity of the participating surgeons in the questionnaire
Primary Purpose:
Treatment
Official Title:
Postoperative Bracing Patterns After Lumbar Surgery for Degenerative Conditions in Belgium
Actual Study Start Date :
Jan 10, 2018
Anticipated Primary Completion Date :
Jun 30, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort: Belgian orthopaedic surgeons & neurosurgeon

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

Outcome Measures

Primary Outcome Measures

  1. Whether or not surgeons typically immobilize patients after specific spinal surgical procedures [2 months]

    yes/no

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

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

  3. Rationale to prescribe a spinal orthosis after specific spinal surgical procedures [2 months]

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

  4. Type of spinal orthosis prescribed after specific spinal surgical procedures [2 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Orthopaedic surgeon or neurosurgeon in Belgium
Exclusion Criteria:
  • N/A

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ/KU Leuven Leuven Vlaams Brabant Belgium 3000

Sponsors and Collaborators

  • Hasselt University
  • Universitaire Ziekenhuizen Leuven
  • KU Leuven

Investigators

  • Principal Investigator: Lotte Janssens, PhD, PT, Hasselt University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lotte Janssens, Prof. dr. Lotte Janssens, Hasselt University
ClinicalTrials.gov Identifier:
NCT03427281
Other Study ID Numbers:
  • KU/UZ Leuven S60109
First Posted:
Feb 9, 2018
Last Update Posted:
Feb 9, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis

Study Results

No Results Posted as of Feb 9, 2018