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.

NCT07845344 | Not Yet Recruiting

• 1 other identifier: 2025-A00427-42
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Stenosis; Bilateral Lumbar Arthrodesis

Outcome Measures

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.

  6 months

Study Arms (1)

Facet arthroplasty with the TOPS™ system or the TOPS™ system + Versa-link™ system

prospective and retrospective collect data

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Facet arthroplasty with the TOPS™ system or the TOPS™ system + Versa-link™ system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective and retrospective collection of data

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique des Cèdres

Cornebarrieu, 31700, France

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jean-François Oudet

CONTACT

0033683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

FR (1)