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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03427281
Other study ID # KU/UZ Leuven S60109
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2018
Est. completion date March 30, 2018

Study information

Verified date February 2020
Source Universitaire Ziekenhuizen KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date March 30, 2018
Est. primary completion date March 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Orthopaedic surgeon or neurosurgeon in Belgium Exclusion Criteria: - N/A

Study Design


Intervention

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

Locations

Country Name City State
Belgium UZ/KU Leuven Leuven Vlaams Brabant

Sponsors (3)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven Hasselt University, KU Leuven

Country where clinical trial is conducted

Belgium, 

References & 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. — View Citation

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/s0 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Whether or not surgeons typically immobilize patients after specific spinal surgical procedures yes/no 2 months
Primary Duration to prescribe a spinal orthosis after specific spinal surgical procedures < 3 weeks, 3-8 weeks, 2-4 months, or > 4 months 2 months
Primary 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
Primary 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
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