Degenerative Lumbar Spinal StenosisFFX® RCTNCT06106061
Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis
A study testing Decompression + FFX® and Decompression alone in people with Degenerative Lumbar Spinal Stenosis, run by SC Medica.
Trial summary
This is a prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant. The main objective is to evaluate the effectiveness of spinal decompression associated with FFX® implants compared to spinal decompression alone in treating lumbar spinal… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis
- What is being tested?
- Decompression + FFX® and Decompression alone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years.
- Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, of 1 to 3 adjacent segments in the L1-S1 region with the need for surgical decompression.
- Radiographic confirmation of no translational instability in main segment as well as in adjacent segments (dynamic translational instability ≤3 mm);
- Visual analogue scale (VAS) back pain score ≥ 50 mm (on a 100-mm scale).
- Minimum of 3 months of conservative therapy without improvement of symptoms.
- Mental \& physical ability of the subject to follow the protocol (i.e., compliance with time schedule \& treatment plan, able to fill in questionnaire \& to undergo further study procedures).
- Personally signed and dated informed consent document prior to any study-related procedures indicating that the subject has been informed of all pertinent aspects of the clinical investigation.
Who cannot join
- Prior lumbar spine surgery.
- Radiographically confirmed damage of a vertebral body (e.g., osteoporotic compression fracture or because of tumours), at any lumbar level.
- Isthmic or degenerative spondylolisthesis (anterolisthesis; retrolisthesis ≥ grade II) or spondylolysis (pars fracture).
- Degenerative lumbar scoliosis (Cobb angle > 25°).
- Adipositas (obesity); defined as a body mass index (BMI) >40.
- Pregnancy, or wish to get pregnant during the course of the study, or breastfeeding.
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- Known allergy or sensitivity to titanium, titanium alloys, or MRI contrast agents.
- Active or chronic infection-systemic or local.
- History of significant peripheral neuropathy.
- Significant peripheral vascular disease (e.g., with diminished dorsalis pedis or posterior tibial pulses).
- Paget disease, osteomalacia or other metabolic bone disorders.
- Cauda equina syndrome.
- Known or documented history of transmissible disease, including AIDS, HIV and active hepatitis.
- More than 3 vertebral levels requiring surgery.
- Disc herniation at any lumbar level requiring surgical intervention.
- Known osteoporosis (bone mineral density, BMD < 120 mg/cm3).
- Chronically taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids), not including a Medrol (methylprednisolone) dose pack.
- Fixed and complete motor, sensory, or reflex deficit.
- Rheumatoid arthritis or other autoimmune diseases.
- Active malignancy: a subject with a history of any invasive malignancy (except non-melanoma skin cancer) unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years. Subjects with a primary bony tumour are excluded as well.
- Subject with a history of substance abuse (e.g., recreational drugs, narcotics, or alcohol).
- Bone destruction, demineralisation or any affection potentially affecting fixation of an implant.
- Spondylodiscitis or spine tumour.
- Currently seeking or receiving workman's compensation.
- In active spinal litigation.
- Subjects who participate(d) in another clinical trial (within the last 4 weeks) that might influence the safety \& effectiveness assessment of this trial.
- Subjects who are lawfully kept in an institution.
- Subject who, in the opinion of the investigator, will be inappropriate for inclusion in this clinical trial or who will not comply with requirements of the study.
- Subject under supervision or legal guardianship, or judicial protection.
- Subject deprived of liberty by judicial or administrative decision.
- Subject not covered by a social security scheme.
About this study
This is a prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant.
The main objective is to evaluate the effectiveness of spinal decompression associated with FFX® implants compared to spinal decompression alone in treating lumbar spinal stenosis after 2 years of treatment.
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Being tested
- Decompression + FFX®, Decompression alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompression + FFX®Device
Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression associated with the use of FFX® implant
Decompression aloneProcedure or surgery
Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression alone
| Study group | Role | What they receive |
|---|---|---|
| Group one: Decompression + FFX® | Experimental | Not described Receives: Device: Decompression + FFX® |
| Group two: Decompression alone | Active comparator | Not described Receives: Procedure: Decompression alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with composite clinical success (CCS)
The CCS will be considered as met if ALL of the following criteria are satisfied for a subject:
- Back pain score (VAS) decrease by more than 20 mm (on 100-mm scale)
- No secondary surgical intervention at the index level (excluding wound problems)
- No non-surgical lumbar treatment of interest at any lumbar level
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 posted30 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 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
- NCT06106061
- Sponsor's protocol ID
- 2023-A01382-43
- Acronym
- FFX® RCT
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT06106061
- Acronym / sponsor ID
- FFX® RCT / 2023-A01382-43
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- SC MedicaIndustry (pharma, biotech, devices)
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 30 Oct 2023 (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 prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant.
The main objective is to evaluate the effectiveness of spinal decompression associated with FFX® implants compared to spinal decompression alone in treating lumbar spinal stenosis after 2 years of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group one: Decompression + FFX® | Experimental | Device: Decompression + FFX® |
| Group two: Decompression alone | Active comparator | Procedure: Decompression alone |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 50 years.
- Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, of 1 to 3 adjacent segments in the L1-S1 region with the need for surgical decompression.
- Radiographic confirmation of no translational instability in main segment as well as in adjacent segments (dynamic translational instability ≤3 mm);
- Visual analogue scale (VAS) back pain score ≥ 50 mm (on a 100-mm scale).
- Minimum of 3 months of conservative therapy without improvement of symptoms.
Key exclusion criteria (31 listed)
- Prior lumbar spine surgery.
- Radiographically confirmed damage of a vertebral body (e.g., osteoporotic compression fracture or because of tumours), at any lumbar level.
- Isthmic or degenerative spondylolisthesis (anterolisthesis; retrolisthesis ≥ grade II) or spondylolysis (pars fracture).
- Degenerative lumbar scoliosis (Cobb angle > 25°).
- Adipositas (obesity); defined as a body mass index (BMI) >40.
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 |
|---|---|---|
| Decompression + FFX®Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression associated with the use of FFX® implant | Device | Group one: Decompression + FFX® |
| Decompression aloneSurgical treatment of degenerative lumbar spinal stenosis by spinal decompression alone | Procedure or surgery | Group two: Decompression alone |
Primary outcome
Proportion of subjects with composite clinical success (CCS)
Time frame: 2 years
The CCS will be considered as met if ALL of the following criteria are satisfied for a subject: * Back pain score (VAS) decrease by more than 20 mm (on 100-mm scale) * No secondary surgical intervention at the index level (excluding wound problems) * No non-surgical lumbar treatment of interest at any lumbar level
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Decompression + FFX® and Decompression alone in people with Degenerative Lumbar Spinal Stenosis, run by SC Medica.
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 7 inclusion and 31 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: opening soon, as of the sponsor's last update on 30 Oct 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of subjects with composite clinical success (CCS) (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 30 Oct 2023.