Lumbar Canal StenosisICASCNCT06555887
Anterior Discectomy Surgery With Arthrodesis in Degenerative Spinal Canal sténoses. (ICASC)
An observational study of Lumbar Canal Stenosis, run by University Hospital, Brest at 1 site in France.
Trial summary
Single-center retrospective study to characterize changes in the functional capacity of patients (change in Oswestry Desability Index (ODI)) undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis between the pre-surgical period and the first assessment 6 months after surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Canal Stenosis
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 31 Oct 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Anterior surgery of central lumbar sténoses
Who may be able to join
- anterior surgical management (ALIF or LLIF)
- symptomatic lumbar degenerative pathology (L1-L2 to L5-S1), objectified on MRI (Schizas B, C, D)
- period from June 2017 to December 2019
Who cannot join
- Traumatic sprains
- History of decompression after the operated stage
- Operated from a later time at the same time
- Scolioses with Cobb angles greater than 10°
- Patients under judicial protection
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Discectomy Surgery With Arthrodesis in Degenerative Spinal Canal Stenoses: a Descriptive Pilot Study
Single-center retrospective study to characterize changes in the functional capacity of patients (change in Oswestry Desability Index (ODI)) undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis between the pre-surgical period and the first assessment 6 months after surgery.
- Conditions
- Lumbar Canal Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize the evolution of functional capacity in patients undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis
Variation in Oswestry Desability Index (ODI) between pre-surgery and first assessment beyond 6 months post-surgery
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Jul 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Canal StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555887
- Sponsor's protocol ID
- 29BRC20.0183 - ICASC
- Acronym
- ICASC
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Discectomy Surgery With Arthrodesis in Degenerative Spinal Canal Stenoses: a Descriptive Pilot Study
- ClinicalTrials.gov ID
- NCT06555887
- Acronym / sponsor ID
- ICASC / 29BRC20.0183 - ICASC
- Conditions
- Lumbar Canal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 15 Aug 2024 (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.
Single-center retrospective study to characterize changes in the functional capacity of patients (change in Oswestry Desability Index (ODI)) undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis between the pre-surgical period and the first assessment 6 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anterior surgery of central lumbar sténoses
Key inclusion criteria (3 listed)
- anterior surgical management (ALIF or LLIF)
- symptomatic lumbar degenerative pathology (L1-L2 to L5-S1), objectified on MRI (Schizas B, C, D)
- period from June 2017 to December 2019
Key exclusion criteria (6 listed)
- Traumatic sprains
- History of decompression after the operated stage
- Operated from a later time at the same time
- Scolioses with Cobb angles greater than 10°
- Patients under judicial protection
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
characterize the evolution of functional capacity in patients undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis
Time frame: 6 month
Variation in Oswestry Desability Index (ODI) between pre-surgery and first assessment beyond 6 months post-surgery
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 15 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Lumbar Canal Stenosis
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Enrolling by invitation
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Canal Stenosis, run by University Hospital, Brest at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 15 Aug 2024. 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 France. 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?
characterize the evolution of functional capacity in patients undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis (time frame: 6 month). 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 15 Aug 2024.