Clinical trial NCT05561322: 3rd-year Post-surgical Evaluation of Adjacent Segment Disc Degeneration Onset in Lumbar Spine (Spinal Fusion vs. Lumbar Arthroplasty With Disc Replacement)
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.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spine Surgery
Keywords: Arthroplasty
Arthrodesis
Disc degeneration
Lumbar spine
Spinal fusion
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients being managed by the Orthopedic,Traumatology and Spine Surgery Department of Nimes University Hospital, France, taken from the hospital's KEOPS database. Patients in the study have all undergone lumbar disk surgery with either a prosthetic disk or arthrodesis with an anterior approach and have at least 3 years of follow-up.

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.

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.

Primary outcomes:
measure: Evaluation of adjacent segment disc degeneration in spinal fusion patients
timeFrame: Day of consultation, at least 3 years after the initial surgery
measure: Evaluation of adjacent segment disc degeneration in lumbar arthroplasty patients
timeFrame: Day of consultation, at least 3 years after surgery
Secondary outcomes:
measure: Adjacent disc degeneration in spinal fusion patients according to the MODIC classification
timeFrame: Day of consultation, at least 3 years after surgery
measure: Adjacent disk degeneration in lumbar arthroplasty patients according to the MODIC classification
timeFrame: Day of consultation, at least 3 years after surgery
measure: Quantification of the evolution of adjacent disk degeneration in spinal fusion patients according to the modified Pfirmann classification.
timeFrame: Day of consultation, at least 3 years after surgery
measure: Quantification of the evolution of adjacent disk degeneration in lumbar arthroplasty patients according to the modified Pfirmann classification.
timeFrame: Day of consultation, at least 3 years after surgery
measure: Disc degeneration count per spinal fusion patient
timeFrame: Day of consultation, at least 3 years after surgery
measure: Disc degeneration count per lumbar arthroplasty patient
timeFrame: Day of consultation, at least 3 years after surgery
measure: Weishaupt classification of disc degeneration in spinal fusion patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Weishaupt classification of disc degeneration in lumbar arthroplasty patients patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Hadar classification in spinal fusion patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Hadar classification in lumbar arthroplasty patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Re-intervention rate among spinal fusion patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Re-intervention rate among lumbar arthroplasty patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Evolution of pain among spinal fusion patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Evolution of pain among lumbar arthroplasty patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Percentage incapacity according to the Oswestry Disability Index in spinal fusion patients.
timeFrame: Day of consultation, at least 3 years after surgery
measure: Percentage incapacity according to the Oswestry Disability Index in lumbar arthroplasty patients.
timeFrame: Day of consultation, at least 3 years after surgery
measure: Fears and Avoidance Beliefs Questionnaire in spinal fusion patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Fears and Avoidance Beliefs Questionnaire in lumbar arthroplasty patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Lasègue manoeuvre in spinal fusion patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Lasègue manoeuvre in lumbar arthroplasty patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Results of the SF-12 Quality of Life questionnaire in spinal fusion patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Results of the SF-12 Quality of Life questionnaire in lumbar arthroplasty patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Results of the Patient Global Impression of Change scale in spinal fusion patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Results of the Patient Global Impression of Change scale in lumbar arthroplasty patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: MRI data acquisition in spinal fusion patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: MRI data acquisition in lumbar arthroplasty patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Body Mass Index of spinal fusion patients
timeFrame: Day of consultation, at least 3 years after surgery
measure: Body Mass Index of lumbar arthroplasty patients
timeFrame: Day of consultation, at least 3 years after surgery
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nîmes University Hospital
state: Gard
Study officials:
References: