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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. ;


Study Design


Related Conditions & MeSH terms


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Status Withdrawn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

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