Degenerative Lumbar Spinal StenosisFACETFIXNCT05645497
Evaluation of the Efficacy and Safety of the FACET FIXation Implant.
An observational study of Degenerative Lumbar Spinal Stenosis, run by SC Medica at 1 site in France.
Trial summary
This is a single center, hybrid retrospective and prospective (ambispective) study to evaluate the safety and efficacy of the Facet Fixation implant. The main objective is to evaluate the efficacy of the Facet Fixation implant compared with pedicle screw fixation to determine successful fusion in radiographic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis
- What is being tested?
- Surgery with FACET FIXATION implants and Surgery with Pedicle Screw
- Type of treatment
- Surgery or procedure
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2023to 30 Apr 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients diagnosed with degenerative lumbar spinal stenosis who underwent their first spinal operation for lumbar decompression with pedicle screws fixation or FACET FIXation implant from 2015 to 2020 (2015-2016 with Pedicle Screw and starting November 2017 with more than 2 years postop at the date of the visit with FACET FIXation implant).
Who may be able to join
- Patient is ≥ 18 years old at the time of the surgery
- The first back operation in the patient's life was for degenerative lumbar spinal stenosis
- Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw fixation or FACET FIXation implant.
- Patient is able to understand the information related to the study
- Patient consents to participate to the clinical investigation and agrees (non-objection) on the use of his/her personal data.
Who cannot join
- Patient received FACET FIXation implant or Pedicle Screw fixation with supplemental interbody cages.
- Unilateral Pedicle Screw or FACET FIXation implant.
- Preoperative grade ≥II spondylolisthesis
- Preoperative scoliotic deviations >25°.
- Protected patient (under legal protection, deprived of liberty by judicial or administrative decision).
- Patient not covered by a social security scheme.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Civils de Colmar
Colmar
Robin SROUR, MD
robin.srour@ch-colmar.fr
About this study
Official title: Evaluation of the Efficacy and Safety of the FACET FIXation Implant Compared With Pedicle Screw Fixation in Patients With Degenerative Lumbar Spinal Stenosis.
This is a single center, hybrid retrospective and prospective (ambispective) study to evaluate the safety and efficacy of the Facet Fixation implant.
The main objective is to evaluate the efficacy of the Facet Fixation implant compared with pedicle screw fixation to determine successful fusion in radiographic assessment at more than two years. Fusion is mainly defined as any sign of bony fusion between the facet joints or transverse processes when viewing the postoperative CT-scan at over 2 years.
Read the detailed description
The primary endpoint is the successful fusion rate in radiographic assessment at more than 2 years.
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Being tested
- Surgery with FACET FIXATION implants, Surgery with Pedicle Screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with FACET FIXATION implantsProcedure or surgery
Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with FACET FIXATION implants
Surgery with Pedicle ScrewProcedure or surgery
Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw
| Study group | Role | What they receive |
|---|---|---|
| Patient with medical device FACET FIXATION | The FACET FIXATION group include all the patients with Lumbar Spinal Stenosis who underwent an open technique for decompression, specifically laminectomies, concomitant to FACET FIXATION from November 2017 (and having more than 2 years postop to date). Receives: Procedure: Surgery with FACET FIXATION implants | |
| Patient with medical device Pedicle Screw | The Pedicle Screw group consiste of all the patients with Lumbar Spinal Stenosis who underwent an open technique for decompression, specifically laminectomies, concomitant to Pedicle Screw fixation from 2015 to 2016. Receives: Procedure: Surgery with Pedicle Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of fusion
The proportion of patients achieving the primary endpoint will be evaluated. The rate of fusion in the radiographic assessment is considered successful if all of the following criteria are achieved :
- Evidence of bridging bone between the facet joints (Facet Fixation implant) or the transverse processes (pedicle screws) via computed tomography scan.
- and ≤ 3mm translational motion between vertebrae on flexion / extension via dynamic X-rays.
- and no evidence of lucency surrounding the device (≤25%).
The main analysis will compare the successful fusion rate at 2+ years post-operative between the group with the Facet Fixation and the group with pedicle screws, by a confidence interval approach.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start17 Jan 2023
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spinal StenosisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SC Medica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645497
- Sponsor's protocol ID
- 2022-A01783-40
- Acronym
- FACETFIX
- Status last verified
- Apr 2023
- First submitted
- 1 Dec 2022
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the FACET FIXation Implant Compared With Pedicle Screw Fixation in Patients With Degenerative Lumbar Spinal Stenosis.
- ClinicalTrials.gov ID
- NCT05645497
- Acronym / sponsor ID
- FACETFIX / 2022-A01783-40
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- SC MedicaIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 9 Dec 2022 (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.
This is a single center, hybrid retrospective and prospective (ambispective) study to evaluate the safety and efficacy of the Facet Fixation implant.
The main objective is to evaluate the efficacy of the Facet Fixation implant compared with pedicle screw fixation to determine successful fusion in radiographic assessment at more than two years. Fusion is mainly defined as any sign of bony fusion between the facet joints or transverse processes when viewing the postoperative CT-scan at over 2 years.
Detailed description
The primary endpoint is the successful fusion rate in radiographic assessment at more than 2 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with medical device FACET FIXATION | – | Procedure: Surgery with FACET FIXATION implantsThe FACET FIXATION group include all the patients with Lumbar Spinal Stenosis who underwent an open technique for decompression, specifically laminectomies, concomitant to FACET FIXATION from November 2017 (and having more than 2 years postop to date). |
| Patient with medical device Pedicle Screw | – | Procedure: Surgery with Pedicle ScrewThe Pedicle Screw group consiste of all the patients with Lumbar Spinal Stenosis who underwent an open technique for decompression, specifically laminectomies, concomitant to Pedicle Screw fixation from 2015 to 2016. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients diagnosed with degenerative lumbar spinal stenosis who underwent their first spinal operation for lumbar decompression with pedicle screws fixation or FACET FIXation implant from 2015 to 2020 (2015-2016 with Pedicle Screw and starting November 2017 with more than 2 years postop at the date of the visit with FACET FIXation implant).
Key inclusion criteria (5 listed)
- Patient is ≥ 18 years old at the time of the surgery
- The first back operation in the patient's life was for degenerative lumbar spinal stenosis
- Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw fixation or FACET FIXation implant.
- Patient is able to understand the information related to the study
- Patient consents to participate to the clinical investigation and agrees (non-objection) on the use of his/her personal data.
Key exclusion criteria (6 listed)
- Patient received FACET FIXation implant or Pedicle Screw fixation with supplemental interbody cages.
- Unilateral Pedicle Screw or FACET FIXation implant.
- Preoperative grade ≥II spondylolisthesis
- Preoperative scoliotic deviations >25°.
- Protected patient (under legal protection, deprived of liberty by judicial or administrative decision).
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 |
|---|---|---|
| Surgery with FACET FIXATION implantsSurgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with FACET FIXATION implants | Procedure or surgery | Patient with medical device FACET FIXATION |
| Surgery with Pedicle ScrewSurgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw | Procedure or surgery | Patient with medical device Pedicle Screw |
Primary outcome
The rate of fusion
Time frame: 2 years
The proportion of patients achieving the primary endpoint will be evaluated. The rate of fusion in the radiographic assessment is considered successful if all of the following criteria are achieved : * Evidence of bridging bone between the facet joints (Facet Fixation implant) or the transverse processes (pedicle screws) via computed tomography scan. * and ≤ 3mm translational motion between vertebrae on flexion / extension via dynamic X-rays. * and no evidence of lucency surrounding the device (≤25%). The main analysis will compare the successful fusion rate at 2+ years post-operative between the group with the Facet Fixation and the group with pedicle screws, by a confidence interval approach.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- 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?
An observational study of Degenerative Lumbar Spinal Stenosis, run by SC Medica 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 5 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: status not confirmed, as of the sponsor's last update on 12 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélie MULLER (3 88 23 71 04 ext. +33, am@sc-medica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of fusion (time frame: 2 years). 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 12 Apr 2023.