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.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Evaluation of adjacent segment disc degeneration in lumbar arthroplasty patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who have given written, informed consent.
- •All patients covered by a health insurance scheme.
- •All patients aged over
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluation of adjacent segment disc degeneration in lumbar arthroplasty patients
时间窗: Day of consultation, at least 3 years after surgery
Adjacent segment disc degeneration in lumbar arthroplasty patients will be evaluated with magnetic resonance imaging.
Evaluation of adjacent segment disc degeneration in spinal fusion patients
时间窗: Day of consultation, at least 3 years after the initial surgery
The onset of adjacent segment disc degeneration in spinal fusion patients will be evaluated with magnetic resonance imaging.
次要结局
- Disc degeneration count per spinal fusion patient(Day of consultation, at least 3 years after surgery)
- Disc degeneration count per lumbar arthroplasty patient(Day of consultation, at least 3 years after surgery)
- Percentage incapacity according to the Oswestry Disability Index in spinal fusion patients.(Day of consultation, at least 3 years after surgery)
- Adjacent disk degeneration in lumbar arthroplasty patients according to the MODIC classification(Day of consultation, at least 3 years after surgery)
- Weishaupt classification of disc degeneration in spinal fusion patients(Day of consultation, at least 3 years after surgery)
- Quantification of the evolution of adjacent disk degeneration in spinal fusion patients according to the modified Pfirmann classification.(Day of consultation, at least 3 years after surgery)
- Hadar classification in spinal fusion patients(Day of consultation, at least 3 years after surgery)
- Re-intervention rate among lumbar arthroplasty patients(Day of consultation, at least 3 years after surgery)
- Evolution of pain among lumbar arthroplasty patients(Day of consultation, at least 3 years after surgery)
- Adjacent disc degeneration in spinal fusion patients according to the MODIC classification(Day of consultation, at least 3 years after surgery)
- Quantification of the evolution of adjacent disk degeneration in lumbar arthroplasty patients according to the modified Pfirmann classification.(Day of consultation, at least 3 years after surgery)
- Weishaupt classification of disc degeneration in lumbar arthroplasty patients patients(Day of consultation, at least 3 years after surgery)
- Hadar classification in lumbar arthroplasty patients(Day of consultation, at least 3 years after surgery)
- Re-intervention rate among spinal fusion patients(Day of consultation, at least 3 years after surgery)
- Evolution of pain among spinal fusion patients(Day of consultation, at least 3 years after surgery)
- Lasègue manoeuvre in lumbar arthroplasty patients(Day of consultation, at least 3 years after surgery)
- Percentage incapacity according to the Oswestry Disability Index in lumbar arthroplasty patients.(Day of consultation, at least 3 years after surgery)
- Fears and Avoidance Beliefs Questionnaire in spinal fusion patients(Day of consultation, at least 3 years after surgery)
- Lasègue manoeuvre in spinal fusion patients(Day of consultation, at least 3 years after surgery)
- Fears and Avoidance Beliefs Questionnaire in lumbar arthroplasty patients(Day of consultation, at least 3 years after surgery)
- Results of the Patient Global Impression of Change scale in spinal fusion patients(Day of consultation, at least 3 years after surgery)
- Body Mass Index of spinal fusion patients(Day of consultation, at least 3 years after surgery)
- Results of the SF-12 Quality of Life questionnaire in spinal fusion patients(Day of consultation, at least 3 years after surgery)
- Results of the Patient Global Impression of Change scale in lumbar arthroplasty patients(Day of consultation, at least 3 years after surgery)
- Results of the SF-12 Quality of Life questionnaire in lumbar arthroplasty patients(Day of consultation, at least 3 years after surgery)
- MRI data acquisition in lumbar arthroplasty patients(Day of consultation, at least 3 years after surgery)
- MRI data acquisition in spinal fusion patients(Day of consultation, at least 3 years after surgery)
- Body Mass Index of lumbar arthroplasty patients(Day of consultation, at least 3 years after surgery)