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Postoperative Bracing Patterns After Lumbar Surgery

Primary Purpose

Lumbar Spine Degeneration, Arthrosis; Spine, Surgery

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

questionnaire

About this trial

This is an interventional treatment trial for Lumbar Spine Degeneration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Orthopaedic surgeon or neurosurgeon in Belgium

Exclusion Criteria:

Sites / Locations

UZ/KU Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort: Belgian orthopaedic surgeons & neurosurgeon

Arm Description

Outcomes

Primary Outcome Measures

Whether or not surgeons typically immobilize patients after specific spinal surgical procedures

yes/no

Duration to prescribe a spinal orthosis after specific spinal surgical procedures

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

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

Type of spinal orthosis prescribed after specific spinal surgical procedures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03427281

First Posted

January 26, 2018

Last Updated

January 26, 2023

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

KU Leuven, Hasselt University

1. Study Identification

Unique Protocol Identification Number

NCT03427281

Brief Title

Postoperative Bracing Patterns After Lumbar Surgery

Official Title

Postoperative Bracing Patterns After Lumbar Surgery for Degenerative Conditions in Belgium

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

January 10, 2018 (Actual)

Primary Completion Date

March 30, 2018 (Actual)

Study Completion Date

March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

KU Leuven, Hasselt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Spine Degeneration, Arthrosis; Spine, Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

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

Allocation

N/A

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort: Belgian orthopaedic surgeons & neurosurgeon

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

questionnaire

Intervention Description

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

Primary Outcome Measure Information:

Title

Whether or not surgeons typically immobilize patients after specific spinal surgical procedures

Description

yes/no

Time Frame

2 months

Title

Duration to prescribe a spinal orthosis after specific spinal surgical procedures

Description

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

Time Frame

2 months

Title

Rationale to prescribe a spinal orthosis after specific spinal surgical procedures

Description

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

Time Frame

2 months

Title

Type of spinal orthosis prescribed after specific spinal surgical procedures

Description

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

Time Frame

2 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Orthopaedic surgeon or neurosurgeon in Belgium Exclusion Criteria: N/A

Overall Study Officials: