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.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial population

Prospective and retrospective collection of data

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Questionnaire

    Other intervention

    Zurich claudication questionnaire : The Zurich Claudication Questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Facet arthroplasty with the TOPS™ system or the TOPS™ system + Versa-link™ system1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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