Postoperative Bracing Patterns After Lumbar Surgery

Surgery Clinical Trial

Official title:

Postoperative Bracing Patterns After Lumbar Surgery for Degenerative Conditions in Belgium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427281
• Other study ID #: KU/UZ Leuven S60109
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arthrosis; Spine
• Lumbar Spine Degeneration
• Osteoarthritis
• Surgery

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