Lumbar Spine DegenerationNCT03427281
Postoperative Bracing Patterns After Lumbar Surgery
A study testing questionnaire in people with Lumbar Spine Degeneration and Arthrosis; Spine, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spine Degeneration, Arthrosis; Spine, Surgery
- What is being tested?
- questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jan 2018to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Orthopaedic surgeon or neurosurgeon in Belgium
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Bracing Patterns After Lumbar Surgery for Degenerative Conditions in Belgium
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.
Read the 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.
- Conditions
- Lumbar Spine Degeneration, Arthrosis; Spine, Surgery
- Being tested
- questionnaire
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireBehavioural
questionnaire to assess the patterns of postoperative bracing use by spinal surgeons in Belgium
| Study group | Role | What they receive |
|---|---|---|
| Cohort: Belgian orthopaedic surgeons & neurosurgeon | Experimental | Not described Receives: Behavioral: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether or not surgeons typically immobilize patients after specific spinal surgical procedures
yes/no
Measured: 2 months
Duration to prescribe a spinal orthosis after specific spinal surgical procedures
< 3 weeks, 3-8 weeks, 2-4 months, or > 4 months
Measured: 2 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
Measured: 2 months
Type of spinal orthosis prescribed after specific spinal surgical procedures
lumbar corset, off the shelf lumbosacral orthosis, and/or costum molded lumbosacral orthosis
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start10 Jan 2018
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine DegenerationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Hasselt University
- Responsible party
- Sponsor
- Investigators
- Bart Depreitere, PhD, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenThijs Swinnen, MSc, Principal investigator, Universitaire Ziekenhuizen KU LeuvenTinne Thys, MSc, Principal investigator, Universitaire Ziekenhuizen KU LeuvenWim Dankaerts, PhD, PT, Principal investigator, KU LeuvenSimon Brumagne, PhD, PT, Principal investigator, KU LeuvenPeter Van Wambeke, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenLieven Moke, PhD, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenSebastiaan Schelfaut, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427281
- Sponsor's protocol ID
- KU/UZ Leuven S60109
- Status last verified
- Feb 2020
- First submitted
- 26 Jan 2018
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18790685Bogaert 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/s00586-018-5837-0. Epub 2018 Nov 28.
PubMed 30488116
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Bracing Patterns After Lumbar Surgery for Degenerative Conditions in Belgium
- ClinicalTrials.gov ID
- NCT03427281
- Acronym / sponsor ID
- KU/UZ Leuven S60109
- Conditions
- Lumbar Spine Degeneration, Arthrosis; Spine, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven, Hasselt University
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort: Belgian orthopaedic surgeons & neurosurgeon | Experimental | Behavioral: questionnaire |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Orthopaedic surgeon or neurosurgeon in Belgium
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairequestionnaire to assess the patterns of postoperative bracing use by spinal surgeons in Belgium | Behavioural | Cohort: Belgian orthopaedic surgeons & neurosurgeon |
Primary outcome
Whether or not surgeons typically immobilize patients after specific spinal surgical procedures
Time frame: 2 months
yes/no
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Background: PubMed 18790685Bible 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.
- Results publication: PubMed 30488116Bogaert 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/s00586-018-5837-0. Epub 2018 Nov 28.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Depreitere, PhD, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Thijs Swinnen, MSc principal investigator
Universitaire Ziekenhuizen KU Leuven
Tinne Thys, MSc principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire in people with Lumbar Spine Degeneration and Arthrosis; Spine, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether or not surgeons typically immobilize patients after specific spinal surgical procedures (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427281, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.