MobilityPhase 4NCT05022745
ERAS Protocol for Single-level Posterior Lumbar Arthrodesisprospective Study.
A Phase 4 study testing Multimodal, multidisciplinary approach in people with Mobility and Opioid Use, run by AZ Nikolaas at 1 site in Belgium.
Trial summary
Enhanced Recovery After Surgery (ERAS) is a multidisciplinary, multimodal approach aiming to improve surgical outcomes. This study compares the length of hospital stay of patients undergoing single-level posterior lumbar arthrodesis and treated with the ERAS protocol with the hospital stay of patients treated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mobility, Opioid Use, Instable Spine
- What is being tested?
- Multimodal, multidisciplinary approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jul 2021to Dec 2022
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for a single level PLIA as treatment of mono segmental degenerative instability, as seen on dynamic X-rays, after the failure of 6 months conservative therapy Capable of understanding the provided information Giving informed consent
Who cannot join
- Revision surgery Arthrodesis for trauma, neoplasms, infection, or listhesis due to lysis. High dose opioid use (step 3 of the WHO pain ladder) Diabetes Cognitive impairment (baseline dementia, cognitive dysfunction, or inability to consent to participate).
- Known kidney insufficiency: GFR <30 mL/min/1.73 m2 Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol Patients with a risk factor for reflux
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
AZ Nikolaas
Sint-Niklaas, 9100
Erik Van de Kelft, MD, PhD, +32 3 760 21 72, Erik.VandeKelft@aznikolaas.be
Peter Verelst, MD, +32 3 760 85 48, Peter.Verelst@aznikolaas.ve
About this study
Official title: ERAS Protocol for Single-level Posterior Lumbar Arthrodesis; a Randomized Prospective Study
Enhanced Recovery After Surgery (ERAS) is a multidisciplinary, multimodal approach aiming to improve surgical outcomes. This study compares the length of hospital stay of patients undergoing single-level posterior lumbar arthrodesis and treated with the ERAS protocol with the hospital stay of patients treated according to the standard protocol.
Read the detailed description
Hundred and ten patients scheduled for single-level posterior lumbar arthrodesis (PLIA) will be randomized to be treated by the standard protocol or the Enhanced Recovery After Surgery (ERAS) protocol. The ERAS protocol differs from the standard protocol in 4 phases: pre-operative counseling and intake, day of surgery, the pre-operative patient preparation, the per-operatively used analgesic and anesthetic drug combination, and the post-operative care consisting of a more intensive physical therapy in the ERAS group. It is the objective the mobilize patients more rapidly without compromising the comfort in terms of pain.
- Conditions
- Mobility, Opioid Use, Instable Spine
- Being tested
- Multimodal, multidisciplinary approach
- Keywords
- Enhanced recovery after surgery (ERAS), Posterior lumbar Interbody arthrodesis (PLIA), length of hospital stay (LOS), opioid use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal, multidisciplinary approachOther
Also called standard treatment
The patient management is adapted pre-operatively, per-operatively and post-operatively
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | Posterior lumbar interbody fusion Multimodal, multidisciplinary patient care. Receives: Other: Multimodal, multidisciplinary approach |
| Standard group | Active comparator | Posterior lumbar interbody fusion Standard treatment pre-, per-, and post-operative Receives: Other: Multimodal, multidisciplinary approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Number of days hospitalization
Measured: 2-3 days + 11 days
Secondary outcomes (3)
Pain intensity
pain intensity on the day of discharge, measured on a 11-point numeric rating scale
Measured: day of discharge
Analgesic use, including opioids
type and dose of analgesics used
Measured: 2-3
11-days readmission rate
patients who return to the hospital for reasons linked to the recovery after surgery
Measured: discharge + 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start8 Jul 2021
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MobilityStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study in patients undergoing PLIA
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Nikolaas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Van de Kelft, M.D., PhD, AZ Nikolaas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022745
- Sponsor's protocol ID
- ERAS for PLIA 2020-12
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERAS Protocol for Single-level Posterior Lumbar Arthrodesis; a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT05022745
- Acronym / sponsor ID
- ERAS for PLIA 2020-12
- Conditions
- Mobility, Opioid Use, Instable Spine
- Keywords
- Enhanced recovery after surgery (ERAS), Posterior lumbar Interbody arthrodesis (PLIA), length of hospital stay (LOS), opioid use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- AZ NikolaasUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 Aug 2021 (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.
Enhanced Recovery After Surgery (ERAS) is a multidisciplinary, multimodal approach aiming to improve surgical outcomes. This study compares the length of hospital stay of patients undergoing single-level posterior lumbar arthrodesis and treated with the ERAS protocol with the hospital stay of patients treated according to the standard protocol.
Detailed description
Hundred and ten patients scheduled for single-level posterior lumbar arthrodesis (PLIA) will be randomized to be treated by the standard protocol or the Enhanced Recovery After Surgery (ERAS) protocol. The ERAS protocol differs from the standard protocol in 4 phases: pre-operative counseling and intake, day of surgery, the pre-operative patient preparation, the per-operatively used analgesic and anesthetic drug combination, and the post-operative care consisting of a more intensive physical therapy in the ERAS group. It is the objective the mobilize patients more rapidly without compromising the comfort in terms of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study in patients undergoing PLIA
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Other: Multimodal, multidisciplinary approachPosterior lumbar interbody fusion Multimodal, multidisciplinary patient care. |
| Standard group | Active comparator | Other: Multimodal, multidisciplinary approachPosterior lumbar interbody fusion Standard treatment pre-, per-, and post-operative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for a single level PLIA as treatment of mono segmental degenerative instability, as seen on dynamic X-rays, after the failure of 6 months conservative therapy Capable of understanding the provided information Giving informed consent
Key exclusion criteria (2 listed)
- Revision surgery Arthrodesis for trauma, neoplasms, infection, or listhesis due to lysis. High dose opioid use (step 3 of the WHO pain ladder) Diabetes Cognitive impairment (baseline dementia, cognitive dysfunction, or inability to consent to participate).
- Known kidney insufficiency: GFR <30 mL/min/1.73 m2 Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol Patients with a risk factor for reflux
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 |
|---|---|---|
| Multimodal, multidisciplinary approachAlso: standard treatmentThe patient management is adapted pre-operatively, per-operatively and post-operatively | Other | ERAS group, Standard group |
Primary outcome
Length of hospital stay
Time frame: 2-3 days + 11 days
Number of days hospitalization
3 secondary outcomes
Pain intensity
Time frame: day of discharge
Analgesic use, including opioids
Time frame: 2-3
11-days readmission rate
Time frame: discharge + 11 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multimodal, multidisciplinary approach in people with Mobility and Opioid Use, run by AZ Nikolaas 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 2 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: status not confirmed, as of the sponsor's last update on 26 Aug 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik Van de Kelft, MD, PhD (+32 3 760 21 72, Erik.vandeKelft@aznikolaas.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 2-3 days + 11 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2021.