Degenerative Cervical Disc DiseaseNCT06876311
Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®
An observational study of Degenerative Cervical Disc Disease and Degenerative Lumbar Diseases, run by Silony Medical GmbH at 1 site in United States.
Trial summary
Post-operative clinical outcome data on the devices used to treat spinal diseases are collected and evaluated in order to analyze the safety and performance of the implants used. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Degenerative Cervical Disc Disease, Degenerative Lumbar Diseases
- What is being tested?
- Anterior Cervical Interbody Fusion, Anterior lumbar Interbody Fusion and Lateral Lumbar Interbody Fusion
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2025to 30 May 2025
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient population is defined by Inclusion and exclusion criteria.
Who may be able to join
- Indications according to IFU
- Surgical implantation of STALIF® C or M FLX device for 1 or 2 levels between:
- STALIF® C FLX: C2-T1 (cervical)
- STALIF® M FLX: L2-S1 (lumbar)
- STALIF® L FLX: L2-L5 (lumbar)
- Surgical implantation of FORTOS-C® for the fusion of up to 3 levels between:
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- FORTOS-C®: C2 - T1 (cervical)
- Age: ≥ 21 years
- For the evaluation of the questionnaires (NDI or ODI, VAS neck and VAS arm or VAS leg and VAS back), only patients with the questionnaire available at the time of admission (pre-op) and at least at 12-months FU will be included
Who cannot join
- Relative and absolute contraindications according to IFU
Trial locations and contacts
1 site in 1 country.
United States1 site
Golden State Orthopedics and Spine
San Ramon, California, 94583
About this study
Official title: Sponsor-initiated, Retrospective, Monocentric, Non-interventional Clinical Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®
Post-operative clinical outcome data on the devices used to treat spinal diseases are collected and evaluated in order to analyze the safety and performance of the implants used.
- Being tested
- Anterior Cervical Interbody Fusion, Anterior lumbar Interbody Fusion, Lateral Lumbar Interbody Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cervical Interbody FusionDevice
Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages
Anterior lumbar Interbody FusionDevice
Standard Anterior Lumbar Interbody Fusion with Stand-Alone Lumbar Cages
Lateral Lumbar Interbody FusionDevice
Standard Lateral Lumbar Interbody Fusion with Stand-alone Lumbar cage
| Study group | Role | What they receive |
|---|---|---|
| FORTOS-C | Patients treated with FORTOS-C Receives: Device: Anterior Cervical Interbody Fusion | |
| STALIF C FLX | Patients treated with STALIF C FLX Receives: Device: Anterior Cervical Interbody Fusion | |
| STALIF M FLX | Patients treated with STALIF M FLX Receives: Device: Anterior lumbar Interbody Fusion | |
| STALIF L FLX | Patients treated with STALIF L FLX Receives: Device: Lateral Lumbar Interbody Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
The Neck Disability Index (NDI) has 10 items that cover various aspects of daily functioning, such as pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
Scoring: Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All section scores are then totaled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst. Alternately, the score can be reported from 0-100. The score is often reported as a percentage (0-100%).
Measured: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Oswestry Disability Index
The Oswestry Disability Index (ODI) is used to measure the extent of pain-related functional limitations in people with low back pain. The questionnaire provides the user with information about the general functional ability of a patient with low back pain in everyday life. Six response options are available for the following items: pain intensity, self-care (washing, dressing), lifting, locomotion, sitting or standing, sleeping, sex life, social life and travel/transportation. The first answer option (score 0) means that there are no pain-related restrictions, while the sixth answer option (score 5) indicates the greatest perceived restriction of an activity due to pain.
Measured: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Secondary outcomes (3)
Visual Analogue Scale
The Visual Analogue Scale (VAS) is usually quantified from 0 to 10, where 0 means 'no pain' and 10 means 'strongest pain imaginable'.
Measured: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Radiological assessment
- Implant migration/ Subsidence/ Screw Back-out
- Bone Fusion at latest follow-up
Measured: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Complications
Intraoperative and postoperative complications, revisions, and (serious) adverse events
Measured: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start4 Mar 2025
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Cervical Disc DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silony Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876311
- Sponsor's protocol ID
- TDI_2023_004_2.1_103
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sponsor-initiated, Retrospective, Monocentric, Non-interventional Clinical Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®
- ClinicalTrials.gov ID
- NCT06876311
- Acronym / sponsor ID
- TDI_2023_004_2.1_103
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Silony Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 14 Mar 2025 (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.
Post-operative clinical outcome data on the devices used to treat spinal diseases are collected and evaluated in order to analyze the safety and performance of the implants used.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FORTOS-C | – | Device: Anterior Cervical Interbody FusionPatients treated with FORTOS-C |
| STALIF C FLX | – | Device: Anterior Cervical Interbody FusionPatients treated with STALIF C FLX |
| STALIF M FLX | – | Device: Anterior lumbar Interbody FusionPatients treated with STALIF M FLX |
| STALIF L FLX | – | Device: Lateral Lumbar Interbody FusionPatients treated with STALIF L FLX |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population is defined by Inclusion and exclusion criteria.
Key inclusion criteria (9 listed)
- Indications according to IFU
- STALIF® C FLX: C2-T1 (cervical)
- STALIF® M FLX: L2-S1 (lumbar)
- STALIF® L FLX: L2-L5 (lumbar)
- FORTOS-C®: C2 - T1 (cervical)
Key exclusion criteria (1 listed)
- Relative and absolute contraindications according to IFU
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 |
|---|---|---|
| Anterior Cervical Interbody FusionStandard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages | Device | FORTOS-C, STALIF C FLX |
| Anterior lumbar Interbody FusionStandard Anterior Lumbar Interbody Fusion with Stand-Alone Lumbar Cages | Device | STALIF M FLX |
| Lateral Lumbar Interbody FusionStandard Lateral Lumbar Interbody Fusion with Stand-alone Lumbar cage | Device | STALIF L FLX |
Primary outcome
Neck Disability Index
Time frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
The Neck Disability Index (NDI) has 10 items that cover various aspects of daily functioning, such as pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring: Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All section scores are then totaled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst. Alternately, the score can be reported from 0-100. The score is often reported as a percentage (0-100%).
Oswestry Disability Index
Time frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
The Oswestry Disability Index (ODI) is used to measure the extent of pain-related functional limitations in people with low back pain. The questionnaire provides the user with information about the general functional ability of a patient with low back pain in everyday life. Six response options are available for the following items: pain intensity, self-care (washing, dressing), lifting, locomotion, sitting or standing, sleeping, sex life, social life and travel/transportation. The first answer option (score 0) means that there are no pain-related restrictions, while the sixth answer option (score 5) indicates the greatest perceived restriction of an activity due to pain.
3 secondary outcomes
Visual Analogue Scale
Time frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Radiological assessment
Time frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Complications
Time frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
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 14 Mar 2025.
- 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.
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 Degenerative Cervical Disc Disease and Degenerative Lumbar Diseases, run by Silony Medical GmbH at 1 site in United States.
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 9 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Mar 2025. 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 United States. 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?
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?
Neck Disability Index (time frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative). The study lists 2 primary outcomes in all. 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 14 Mar 2025.