Spinal StenosisTOPSNCT07845344
Combined Analysis of Retrospective and Prospective Data From Patients Who Underwent Facet Arthroplasty With the TOPS™ System or the TOPS + Versalink™ Fixation System at a Single Center.
An observational study of Spinal Stenosis and Bilateral Lumbar Arthrodesis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The TOPS™ system is an alternative to spinal fusion designed to stabilize-rather than fuse-the affected vertebral level, thereby relieving pain caused by degenerative spondylolisthesis and spinal stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis, Bilateral Lumbar Arthrodesis
- What is being tested?
- Questionnaire
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2026to 30 Nov 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective and retrospective collection of data
Who may be able to join
- Male or female patient aged over 18 years,
- All consecutively treated patients who underwent facet arthroplasty using the TOPS™ system or the TOPS™ system + VersaLink™ system at a single center, and for whom the surgery was performed at least 6 months prior to the start of data collection,
- Patient who has received written information and has not objected to participating in the study,
- Patient capable of understanding the study and answering the Zurich Claudication Questionnaire,
- Patient affiliated with or a beneficiary of a social security scheme.
Who cannot join
- Minor patient,
- Patient treated consecutively who received the TOPS™ system or the TOPS™ system + Versalink™ fixation system at multiple surgical centers,
- Patient refusal to participate in the study,
- Protected patient: adult under guardianship, curatorship, or other legal protection; deprived of liberty by judicial or administrative decision,
- Pregnant, breastfeeding, or recently delivered woman.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Hélène Barba contact
France1 site
Clinique des Cèdres
Cornebarrieu, 31700
Jean-Paul Lescure, Dr, 0033562133369, jean-paul.lescure@orange.fr
About this study
The TOPS™ system is an alternative to spinal fusion designed to stabilize-rather than fuse-the affected vertebral level, thereby relieving pain caused by degenerative spondylolisthesis and spinal stenosis. Degenerative spondylolisthesis involves abnormal, excessive vertebral movement, resulting in lower back and leg pain.
Spinal stenosis is a condition in which nerve compression causes symptoms such as pain, numbness, and tingling in the legs. The TOPS system is intended to provide stabilization for skeletally mature patients with single-level disease (L3-L5) who have not achieved sufficient symptom relief through prior conservative care. The Total Posterior Spine System ("TOPS™ system") received CE marking and has been commercially available since 2012; it also received US FDA approval in June 2023.
Read more
The Versalink™ fixation system is a bilateral titanium lumbar fusion system designed for use with a titanium cross-link as a standalone fusion device. It is also designed to connect above or below the TOPS™ device to form a hybrid construct.
The TOPS system is designed to restore lumbar spine stability while allowing for spinal canal decompression (laminectomy/facetectomy).
By using the TOPS™ system, the surgeon can remove pathological bony elements and implant a posterior spine replacement technology that effectively recreates load-bearing dynamics and spinal biomechanics, thereby preserving mobility in the treated segment.
- Conditions
- Spinal Stenosis, Bilateral Lumbar Arthrodesis
- Being tested
- Questionnaire
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Zurich claudication questionnaire : The Zurich Claudication Questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Facet arthroplasty with the TOPS™ system or the TOPS™ system + Versa-link™ system | prospective and retrospective collect data Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction will be assessed by administering the patient satisfaction scale of the Zurich Claudication Questionnaire at the final follow-up visit. Each patient's satisfaction threshold will be defined as a raw score of 2.5 or lower on the ZCQ patient satisfaction scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845344
- Sponsor's protocol ID
- 2025-A00427-42
- Acronym
- TOPS
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Analysis of Retrospective and Prospective Data From Patients Who Underwent Facet Arthroplasty With the TOPS™ System or the TOPS + Versalink™ Fixation System at a Single Center.
- ClinicalTrials.gov ID
- NCT07845344
- Acronym / sponsor ID
- TOPS / 2025-A00427-42
- Conditions
- Spinal Stenosis, Bilateral Lumbar Arthrodesis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 28 Sep 2026 (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.
The TOPS™ system is an alternative to spinal fusion designed to stabilize-rather than fuse-the affected vertebral level, thereby relieving pain caused by degenerative spondylolisthesis and spinal stenosis. Degenerative spondylolisthesis involves abnormal, excessive vertebral movement, resulting in lower back and leg pain.
Spinal stenosis is a condition in which nerve compression causes symptoms such as pain, numbness, and tingling in the legs. The TOPS system is intended to provide stabilization for skeletally mature patients with single-level disease (L3-L5) who have not achieved sufficient symptom relief through prior conservative care. The Total Posterior Spine System ("TOPS™ system") received CE marking and has been commercially available since 2012; it also received US FDA approval in June 2023.
The Versalink™ fixation system is a bilateral titanium lumbar fusion system designed for use with a titanium cross-link as a standalone fusion device. It is also designed to connect above or below the TOPS™ device to form a hybrid construct.
The TOPS system is designed to restore lumbar spine stability while allowing for spinal canal decompression (laminectomy/facetectomy).
By using the TOPS™ system, the surgeon can remove pathological bony elements and implant a posterior spine replacement technology that effectively recreates load-bearing dynamics and spinal biomechanics, thereby preserving mobility in the treated segment.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facet arthroplasty with the TOPS™ system or the TOPS™ system + Versa-link™ system | – | Other: Questionnaireprospective and retrospective collect data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective and retrospective collection of data
Key inclusion criteria (5 listed)
- Male or female patient aged over 18 years,
- All consecutively treated patients who underwent facet arthroplasty using the TOPS™ system or the TOPS™ system + VersaLink™ system at a single center, and for whom the surgery was performed at least 6 months prior to the start of data collection,
- Patient who has received written information and has not objected to participating in the study,
- Patient capable of understanding the study and answering the Zurich Claudication Questionnaire,
- Patient affiliated with or a beneficiary of a social security scheme.
Key exclusion criteria (5 listed)
- Minor patient,
- Patient treated consecutively who received the TOPS™ system or the TOPS™ system + Versalink™ fixation system at multiple surgical centers,
- Patient refusal to participate in the study,
- Protected patient: adult under guardianship, curatorship, or other legal protection; deprived of liberty by judicial or administrative decision,
- Pregnant, breastfeeding, or recently delivered woman.
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 |
|---|---|---|
| QuestionnaireZurich claudication questionnaire : The Zurich Claudication Questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment. | Other | Facet arthroplasty with the TOPS™ system or the TOPS™ system + Versa-link™ system |
Primary outcome
Patient satisfaction
Time frame: 6 months
Patient satisfaction will be assessed by administering the patient satisfaction scale of the Zurich Claudication Questionnaire at the final follow-up visit. Each patient's satisfaction threshold will be defined as a raw score of 2.5 or lower on the ZCQ patient satisfaction scale.
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 28 Sep 2026.
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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.
Marie-Hélène Barba contact
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 Spinal Stenosis and Bilateral Lumbar Arthrodesis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 5 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 28 Sep 2026. 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?
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?
Contact Jean-François Oudet (0033683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 6 months). 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 28 Sep 2026.