Lumbar Spine DegenerationNCT03427294

Delphi Study on Rehabilitation Following Lumbar Arthrodesis

An observational study of Lumbar Spine Degeneration and Physical Disability, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Delphi study on perioperative rehabilitation after single and double level lumbar arthrodesis. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Lumbar Spine Degeneration, Physical Disability, Surgery
What is being tested?: Delphi study
How many people: 31 participants
Where: 1 siteBelgium
Study dates: 3 Jan 2018to 31 Dec 2019
How long will I take part?: 1 Year
Phase: Observational
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: The investigators aim to engage all care providers (Belgium, the Netherlands) who are involved in the care of patients following lumbar arthrodesis.

Who may be able to join

The investigators aim to engage all care providers (Belgium, the Netherlands) who are involved in the care of patients following lumbar arthrodesis.

Who cannot join

Trial locations and contacts

1 site in 1 country.

Belgium1 site

UZ/KU Leuven
Leuven, Vlaams Brabant, 3000

Other trials in Belgium

About this study

Official title: Delphi Study on Rehabilitation Following Lumbar Arthrodesis in UZ Leuven (Belgium)

Delphi study on perioperative rehabilitation after single and double level lumbar arthrodesis.

Read the detailed description

The investigators aim to engage all care providers in Belgium and the Netherlands who are at some point involved in the rehabilitation path related to single and double level lumbar arthrodesis.

Conditions: Lumbar Spine Degeneration, Physical Disability, Surgery
Being tested: Delphi study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Delphi studyOther
Delphi study on the optimal rehabilitation pathway following lumbar arthrodesis

Study groups in NCT03427294
Study group	Role	What they receive
Care providers involved in lumbar arthrodesis		surgeons, physiotherapists, behavioral therapists, researchers, occupational therapists Receives: Other: Delphi study

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of perioperative rehabilitation following lumbar arthrodesis
duration defined in amount of weeks
Measured: January - December 2018
Physiotherapeutic content following lumbar arthrodesis
describing the physiotherapeutic modalities defined as manual therapy, exercise therapy, or cognitive behavioural therapy
Measured: January - December 2018
Frequency of physiotherapeutic intervention following lumbar arthrodesis
frequency defined as amount of physiotherapeutic visits per week
Measured: January - December 2018
Multidisciplinary character of perioperative rehabilitation following lumbar arthrodesis
amount and type of involved health care providers, as well as the interaction between
Measured: January - December 2018

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 201831 Dec 2019

First posted9 Feb 2018
Study start3 Jan 2018
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 31 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT03427294
Sponsor's protocol ID: KU/UZ Leuven S60109 - 2
Status last verified: Feb 2022
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

Thys T, Bogaert L, Dankaerts W, Depreitere B, Van Wambeke P, Brumangne S, Bultheel M, Vanden Abeele V, Moke L, Spriet A, Schelfaut S, Janssens L, Swinnen TW. Qualitative study exploring the views of patients and healthcare providers on current rehabilitation practices after lumbar fusion surgery. BMJ Open. 2024 May 30;14(5):e077786. doi: 10.1136/bmjopen-2023-077786.
PubMed 38816040

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease

All Lumbar Spine Degeneration trials

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: Delphi Study on Rehabilitation Following Lumbar Arthrodesis in UZ Leuven (Belgium)
ClinicalTrials.gov ID: NCT03427294
Acronym / sponsor ID: KU/UZ Leuven S60109 - 2
Conditions: Lumbar Spine Degeneration, Physical Disability, Surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
Collaborators: UHasselt, KU Leuven
Study start: 3 Jan 2018 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (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.

Delphi study on perioperative rehabilitation after single and double level lumbar arthrodesis.

Detailed description

The investigators aim to engage all care providers in Belgium and the Netherlands who are at some point involved in the rehabilitation path related to single and double level lumbar arthrodesis.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year
Number of arms: 1

Arm	Type	Receives
Care providers involved in lumbar arthrodesis	–	Other: Delphi studysurgeons, physiotherapists, behavioral therapists, researchers, occupational therapists

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: The investigators aim to engage all care providers (Belgium, the Netherlands) who are involved in the care of patients following lumbar arthrodesis.

Key inclusion criteria (1 listed)

The investigators aim to engage all care providers (Belgium, the Netherlands) who are involved in the care of patients following lumbar arthrodesis.

Key exclusion criteria (1 listed)

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
Delphi studyDelphi study on the optimal rehabilitation pathway following lumbar arthrodesis	Other	Care providers involved in lumbar arthrodesis

Primary outcome

Duration of perioperative rehabilitation following lumbar arthrodesis
Time frame: January - December 2018
duration defined in amount of weeks
Physiotherapeutic content following lumbar arthrodesis
Time frame: January - December 2018
describing the physiotherapeutic modalities defined as manual therapy, exercise therapy, or cognitive behavioural therapy
Frequency of physiotherapeutic intervention following lumbar arthrodesis
Time frame: January - December 2018
frequency defined as amount of physiotherapeutic visits per week
Multidisciplinary character of perioperative rehabilitation following lumbar arthrodesis
Time frame: January - December 2018
amount and type of involved health care providers, as well as the interaction between

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.
Derived from this study: PubMed 38816040Thys T, Bogaert L, Dankaerts W, Depreitere B, Van Wambeke P, Brumangne S, Bultheel M, Vanden Abeele V, Moke L, Spriet A, Schelfaut S, Janssens L, Swinnen TW. Qualitative study exploring the views of patients and healthcare providers on current rehabilitation practices after lumbar fusion surgery. BMJ Open. 2024 May 30;14(5):e077786. doi: 10.1136/bmjopen-2023-077786.
Individual participant dataSharing planned: Undecided

Related trials for Lumbar Spine Degeneration

Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease

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, PT principal investigator

Universitaire Ziekenhuizen KU Leuven

Tinne Thys, MSc, PT 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?

An observational study of Lumbar Spine Degeneration and Physical Disability, 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?

Duration of perioperative rehabilitation following lumbar arthrodesis (time frame: January - December 2018). 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 NCT03427294, which also lists 1 linked publication.

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.