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

Centre Hospitalier Universitaire de Nīmes

Status

Withdrawn

Conditions

Spine Surgery

Treatments

Other: Magnetic Resonance Imaging of the lumbar spine

Other: Consultation involving pain evaluation, questionnaires and the Lasègue Manoeuver

Study type

Observational

Funder types

Other

Identifiers

NCT05561322

NIMAO/2018-02/PK-01

RCB no. (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients who have given written, informed consent.
All patients covered by a health insurance scheme.
All patients aged over 18.
All patients operated with a lumbar spine disk prosthesis or vertebral arthrodesis with an anterior approach at the Orthopedic, Traumatology and Spine Surgery Department of Nimes University Hospital, France, at least 3 years previously.
All patients who have undergone initial MRI before surgery.

Exclusion criteria

Any patient taking part in a category 1 interventional study and in an exclusion period determined by a previous study.
Any patient under legal protection, guardianship or tutorship.
Any patient who refuses to sign the consent form.
Any patient for whom it is impossible to give clear information.
Any patient with contra-indications for Magnetic Resonance Imaging such as an incompatible pacemaker, claustrophobia, metal apparatus or prosthetic hip.
Any patient with a septic complication.
Any patient with instrumentation or posterior arthrodesis.