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Completed

NCT Number: NCT03427281

Postoperative Bracing Patterns After Lumbar Surgery

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.

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Key information

Conditions

Lumbar Spine Degeneration Arthritis Arthrosis; Spine Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ/KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Orthopaedic surgeon or neurosurgeon in Belgium

Exclusion criteria

  • N/A

Treatment and study plan

Questionnaire

Behavioral

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

Primary outcomes

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

    Time frame: 2 months

    yes/no

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Hasselt University
  • KU Leuven

Registry information

Official study title

Postoperative Bracing Patterns After Lumbar Surgery for Degenerative Conditions in Belgium

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2018
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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