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

NCT ID: NCT05561322

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2024-02-27

Brief 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.

Detailed 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.

Conditions

Spine Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Spinal fusion patients

Patients who have undergone spinal fusion surgery and have had at least 3 years of follow-up.

Consultation involving pain evaluation, questionnaires and the Lasègue Manoeuver

Intervention Type: OTHER

Raising the lower limb with the knee in extension reproduces sciatica pain if there is an impression of discal pain with its origin at the roots of the sciatica nerve L5 and S1. This test is evaluated by the degree of elevation of the lower limb relative to the examination table. During the Lasègue manoeuvre the sciatica pain is improved during dorsal flexion of the foot.The doctor notes whether the Lasègue manoeuvre done on the healthy side exacerbates the pain on the opposite side. It is said that contralateral Lasègue sign is positive.

Magnetic Resonance Imaging of the lumbar spine

Intervention Type: OTHER

Sagittal proton density-weighted Dixon sequence on the lumbar spine and axial T2-weighted spin echo sequence on the lumbar discs.

Lumbar arthroplasty patients

Patients who have undergone lumbar arthroplasty with disc replacement and have had at least 3 years of follow-up.

Consultation involving pain evaluation, questionnaires and the Lasègue Manoeuver

Intervention Type: OTHER

Raising the lower limb with the knee in extension reproduces sciatica pain if there is an impression of discal pain with its origin at the roots of the sciatica nerve L5 and S1. This test is evaluated by the degree of elevation of the lower limb relative to the examination table. During the Lasègue manoeuvre the sciatica pain is improved during dorsal flexion of the foot.The doctor notes whether the Lasègue manoeuvre done on the healthy side exacerbates the pain on the opposite side. It is said that contralateral Lasègue sign is positive.

Magnetic Resonance Imaging of the lumbar spine

Intervention Type: OTHER

Sagittal proton density-weighted Dixon sequence on the lumbar spine and axial T2-weighted spin echo sequence on the lumbar discs.

Interventions

Consultation involving pain evaluation, questionnaires and the Lasègue Manoeuver

Raising the lower limb with the knee in extension reproduces sciatica pain if there is an impression of discal pain with its origin at the roots of the sciatica nerve L5 and S1. This test is evaluated by the degree of elevation of the lower limb relative to the examination table. During the Lasègue manoeuvre the sciatica pain is improved during dorsal flexion of the foot.The doctor notes whether the Lasègue manoeuvre done on the healthy side exacerbates the pain on the opposite side. It is said that contralateral Lasègue sign is positive.

Intervention Type: OTHER

Magnetic Resonance Imaging of the lumbar spine

Sagittal proton density-weighted Dixon sequence on the lumbar spine and axial T2-weighted spin echo sequence on the lumbar discs.

Intervention Type: OTHER

Other Intervention Names

Lasègue manoeuver

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nîmes University Hospital

Nîmes, Gard, France

Countries

France

Other Identifiers

RCB no.

Identifier Type: REGISTRY

Identifier Source: secondary_id

NIMAO/2018-02/PK-01

Identifier Type: -

Identifier Source: org_study_id