3rd-year Post-surgical Evaluation of Adjacent Segment Disc Degeneration Onset in Lumbar Spine (Spinal Fusion vs. Lumbar Arthroplasty With Disc Replacement) — ARTHRO-DEGE  

Spine Surgery Clinical Trial

Official title: Third Year Post-surgical Evaluation of Onset of Adjacent Segment Disc Degeneration in the Lumbar Spine According to the Initial Technique (Spinal Fusion Versus Lumbar Arthroplasty With Disc Replacement). A Monocentric Prospective Non-randomized Cohort Study.

Status Withdrawn

Clinical Trial Summary

The main objective of the study is to compare the onset of adjacent segment disk degeneration in two groups of patients (one "spinal fusion group" and one "lumbar arthroplasty with disc replacement" group) with each patient acting as their own control for either group under study and more than three years of follow-up.

Clinical Trial Description

This is a non-randomized prospective monocentric open cohort study. Patients whose surgical intervention goes back to more than 3 years will be preselected from the KEOPS database and contacted by phone. Information on the study and its restrictions is delivered to the patient. The investigator organizes the inclusion visit. The patient is seen for consultation by the orthopedic surgeon (inclusion visit /end of research) ; the information notice is given to the patient who is free to ask questions about the study. The patient's consent is collected. The investigator proceeds with a clinical examination (the Lasègue manoeuver), evaluates pain (EVN, DN4) and administers four different questionnaires . The patient is then oriented towards the imaging department where he/she will have the benefit of and Magnetic Resonance Imaging and also a spinal X-ray(front and profile ; Roussouly classification). The patient's participation in the study ends once the examination is over. The consultation in the orthopedic department and the imaging session will be planned in such a way that they can be performed all on the same day. The study program provides for 12 months of inclusion and 4 months of data management, statistical analysis and writing up the report on the study. ;

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Spine Surgery

• NCT number: NCT05561322
• Study type: Observational
• Source: Centre Hospitalier Universitaire de Nimes
• Status: Withdrawn
• Start date: February 27, 2024
• Completion date: February 27, 2024