RehabilitationNCT03096600
Evaluation of Fast Track Rehabilitaion in Mini-invasive Lombar Arthrodesis
An observational study of Rehabilitation, run by Fondation Hôpital Saint-Joseph.
Trial summary
Mini invasive spine surgery have become very common in the past years. Posterior arthrodesis associated to liberation have good functional results and doesn't present much complication cases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rehabilitation
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Feb 2017to 31 Dec 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Indications for transforaminal lumbar interbody fusion
Who may be able to join
- patient accepting fast track réhabilitation for transforaminal lumbar interbody fusion
- age >18 hears
Who cannot join
- Age >75
- ASA score >2
- long distance between house and hôpital
- socially isolantes
- pathology needed conventional hospitalisation
- psychiatric pathology
About this study
Mini invasive spine surgery have become very common in the past years. Posterior arthrodesis associated to liberation have good functional results and doesn't present much complication cases.
So that's why St Joseph Hospital spine surgeon have made the hypothesis that this kind of surgery can be associated to fast track surgery.
- Conditions
- Rehabilitation
- Keywords
- spine
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of passage to conventional hospitalization
Measured: week 1
Secondary outcomes (2)
Assessment of percentage of patients accepting fast track rehabilitation
Measured: day1
Early complication rate
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start9 Feb 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Why it stopped: The principal investigator has left the hospital.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pomme JOUFROY, MD, Study director, GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096600
- Sponsor's protocol ID
- MISS RAL
- Status last verified
- Feb 2020
- First submitted
- 26 Mar 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fast Track Rehabilitaion in Mini-invasive Lombar Arthrodesis
- ClinicalTrials.gov ID
- NCT03096600
- Acronym / sponsor ID
- MISS RAL
- Conditions
- Rehabilitation
- Keywords
- spine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The principal investigator has left the hospital.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Mar 2017 (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.
Mini invasive spine surgery have become very common in the past years. Posterior arthrodesis associated to liberation have good functional results and doesn't present much complication cases.
So that's why St Joseph Hospital spine surgeon have made the hypothesis that this kind of surgery can be associated to fast track surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Indications for transforaminal lumbar interbody fusion
Key inclusion criteria (2 listed)
- patient accepting fast track réhabilitation for transforaminal lumbar interbody fusion
- age >18 hears
Key exclusion criteria (6 listed)
- Age >75
- ASA score >2
- long distance between house and hôpital
- socially isolantes
- pathology needed conventional hospitalisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of passage to conventional hospitalization
Time frame: week 1
2 secondary outcomes
Assessment of percentage of patients accepting fast track rehabilitation
Time frame: day1
Early complication rate
Time frame: day 30
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- 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.
Pomme JOUFROY, MD study director
GHPSJ
Questions about this trial
What is this clinical trial studying?
An observational study of Rehabilitation, run by Fondation Hôpital Saint-Joseph.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of passage to conventional hospitalization (time frame: week 1). 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 5 Feb 2020.