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

Spine Surgery Clinical Trial

— ARTHRO-DEGE  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05561322
• Other study ID #: NIMAO/2018-02/PK-01
• Secondary ID: RCB no.
• Status: Withdrawn
• Start date: February 27, 2024
• Est. completion date: February 27, 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Spine Surgery

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
France	Nîmes University Hospital	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of adjacent segment disc degeneration in spinal fusion patients	The onset of adjacent segment disc degeneration in spinal fusion patients will be evaluated with magnetic resonance imaging.	Day of consultation, at least 3 years after the initial surgery
Primary	Evaluation of adjacent segment disc degeneration in lumbar arthroplasty patients	Adjacent segment disc degeneration in lumbar arthroplasty patients will be evaluated with magnetic resonance imaging.	Day of consultation, at least 3 years after surgery
Secondary	Adjacent disc degeneration in spinal fusion patients according to the MODIC classification	The classification by Michael MODIC evaluates the stage of disk degeneration seen with magnetic resonance imaging as follows : Stage 0 : Disc appears black on sequences 1 and 2. Dehydration of disk without retraction of the vertebral end plates.; Stage 1 : Disc appears black on sequence 1 but white on sequence 2. Inflammatory reaction on vertebral end plates. Swollen aspect.; Stage 2: Disc appears white on both sequences 1 and 2. Fatty reaction of vertebral end plates. Fatty aspect.; Stage 3: Disc appears black on both sequences 1 and 2. Bony sclerosis.	Day of consultation, at least 3 years after surgery
Secondary	Adjacent disk degeneration in lumbar arthroplasty patients according to the MODIC classification	The classification by Michael MODIC evaluates the stage of disc degeneration seen with magnetic resonance imaging as follows : Stage 0 : Disc appears black on sequences 1 and 2. Dehydration of disc without retraction of the vertebral end plates.; Stage 1 : Disc appears black on sequence 1 but white on sequence 2. Inflammatory reaction on vertebral end plates. Swollen aspect.; Stage 2: Disc appears white on both sequences 1 and 2. Fatty reaction of vertebral end plates. Fatty aspect.; Stage 3: Disc appears black on both sequences 1 and 2. Bony sclerosis.	Day of consultation, at least 3 years after surgery
Secondary	Quantification of the evolution of adjacent disk degeneration in spinal fusion patients according to the modified Pfirmann classification.	The modified Pfirmann classification is used to grade disc degeneration as seen on magnetic resonance imaging with T2-weighted sagittal or STIR sequences. Grade 1 corresponds to a healthy disc rarely observed in adults. Grade 5 corresponds to disk collapse.	Day of consultation, at least 3 years after surgery
Secondary	Quantification of the evolution of adjacent disk degeneration in lumbar arthroplasty patients according to the modified Pfirmann classification.	The modified Pfirmann classification is used to grade disc degeneration as seen on magnetic resonance imaging with T2-weighted sagittal or STIR sequences. Grade 1 corresponds to a healthy disc rarely observed in adults. Grade 5 corresponds to disk collapse.	Day of consultation, at least 3 years after surgery
Secondary	Disc degeneration count per spinal fusion patient	The number of points of degeneration, just above or just below the operated segment, will be counted for each patient.	Day of consultation, at least 3 years after surgery
Secondary	Disc degeneration count per lumbar arthroplasty patient	The number of points of degeneration, just above or just below the operated segment, will be counted for each patient.	Day of consultation, at least 3 years after surgery
Secondary	Weishaupt classification of disc degeneration in spinal fusion patients	The Weishaupt classification classifies arthritis of the lumbar facet joints as follows: Grade 0: Normal facet joint space (2±4 mm width) Grade 1: Narrowing of the facet joint space (< 2 mm) and/or small osteophytes and/or mild hypertrophy of the articular process Grade 2: Narrowing of the facet joint space and/or moderate osteophytes and/or moderate hypertrophy of the articular process and/or mild subarticular bone erosions Grade 3: Narrowing of the facet joint space and/or large osteophytes and/or severe hypertrophy of the articular process and/or severe subarticular bone erosions and/or subchondral cysts	Day of consultation, at least 3 years after surgery
Secondary	Weishaupt classification of disc degeneration in lumbar arthroplasty patients patients	The Weishaupt classification classifies arthritis of the lumbar facet joints as follows: Grade 0: Normal facet joint space (2±4 mm width) Grade 1: Narrowing of the facet joint space (< 2 mm) and/or small osteophytes and/or mild hypertrophy of the articular process Grade 2: Narrowing of the facet joint space and/or moderate osteophytes and/or moderate hypertrophy of the articular process and/or mild subarticular bone erosions Grade 3: Narrowing of the facet joint space and/or large osteophytes and/or severe hypertrophy of the articular process and/or severe subarticular bone erosions and/or subchondral cysts	Day of consultation, at least 3 years after surgery
Secondary	Hadar classification in spinal fusion patients	Backache has an effect on the muscles provoking a gradual degeneration of muscle fat. Hadar proposes a 3-stage scale to classify the fibroadipose tissue.	Day of consultation, at least 3 years after surgery
Secondary	Hadar classification in lumbar arthroplasty patients	Backache has an effect on the muscles provoking a gradual degeneration of muscle fat. Hadar proposes a 3-stage scale to classify the fibroadipose tissue	Day of consultation, at least 3 years after surgery
Secondary	Re-intervention rate among spinal fusion patients	The number of re-interventions among spinal fusion patients will be recorded as a percentage.	Day of consultation, at least 3 years after surgery
Secondary	Re-intervention rate among lumbar arthroplasty patients	The number of re-interventions among lumbar arthroplasty patients will be recorded as a percentage.	Day of consultation, at least 3 years after surgery
Secondary	Evolution of pain among spinal fusion patients	The DN4 hetero-questionnaire (" Neuropathic pain in 4 Questions ") is validated in French and evaluates the possible presence of neuropathic-type pain in a patient (Bouhassira et al. 2005). It consists of 4 questions (2 at the interview, 2 during the examination and 10 items for which the patient has to answer YES or NO. Each " YES" validates one point, each " NO " does not validate a point. If the score is =4,the test is positive.	Day of consultation, at least 3 years after surgery
Secondary	Evolution of pain among lumbar arthroplasty patients	The DN4 hetero-questionnaire (" Neuropathic pain in 4 Questions ") is validated in French and evaluates the possible presence of neuropathic-type pain in a patient (Bouhassira et al. 2005). It consists of 4 questions (2 at the interview, 2 during the examination and 10 items for which the patient has to answer YES or NO. Each " YES" validates one point, each " NO " does not validate a point. If the score is =4,the test is positive.	Day of consultation, at least 3 years after surgery
Secondary	Percentage incapacity according to the Oswestry Disability Index in spinal fusion patients.	The Oswestry Disability Index is one of the most widely-used disability scales in the Anglophone world used to evaluate functional incapacity in patients with backache. It may be used not only in clinical studies but also by the General Practitioner to evaluate the evolution of a patient's functional incapacity. It contains 10 sections and at least 8 must be completed in order for the score to be calculable. It is expressed as percentage incapacity by multiplying by two the sum of the answers graduated 0 to 5 for each item. It has been validated in English ( Fisher & Johnston 1997; Little et MacDonald 1994; Fritz et Irrgang 2001; Grönblad et al. 1993; Fairbank and Pynsent 2000) and its French translation was validated in 2008 (Vogler et al. 2008).	Day of consultation, at least 3 years after surgery
Secondary	Percentage incapacity according to the Oswestry Disability Index in lumbar arthroplasty patients.	The Oswestry Disability Index is one of the most widely-used disability scales in the Anglophone world used to evaluate functional incapacity in patients with backache. It may be used not only in clinical studies but also by the General Practitioner to evaluate the evolution of a patient's functional incapacity. It contains 10 sections and at least 8 must be completed in order for the score to be calculable. It is expressed as percentage incapacity by multiplying by two the sum of the answers graduated 0 to 5 for each item. It has been validated in English ( Fisher & Johnston 1997; Little et MacDonald 1994; Fritz et Irrgang 2001; Grönblad et al. 1993; Fairbank and Pynsent 2000) and its French translation was validated in 2008 (Vogler et al. 2008).	Day of consultation, at least 3 years after surgery
Secondary	Fears and Avoidance Beliefs Questionnaire in spinal fusion patients	The notions of apprehension-avoidance of beliefs font part of the psychosocial factors associated with the onset, maintenance and reinforcement of the chronic pain process. Their evaluation is made with the FABQ questionnaire whose original English version was validated in 1993 by Waddell et al. (1993) and the French version in 2004 (Chaory et al.2004). The patient's fears, beliefs and avoidance attitudes are predictive of the result and observance of treatment, particularly functional restoration programs (Pfingsten et al. 2000). The FABQ is a self-questionnaire with 16 items rated 0 to 6 on a Likert scale (0 = absolutely disagree, 6 = completely agree) ; the questions focus on the appreciation of notions of apprehension relative to professional activities and other physical activities. It takes about 10 minutes to complete the questionnaire. A high score represents a high rate of fears and beliefs.	Day of consultation, at least 3 years after surgery
Secondary	Fears and Avoidance Beliefs Questionnaire in lumbar arthroplasty patients	The notions of apprehension-avoidance of beliefs font part of the psychosocial factors associated with the onset, maintenance and reinforcement of the chronic pain process. Their evaluation is made with the FABQ questionnaire whose original English version was validated in 1993 by Waddell et al. (1993) and the French version in 2004 (Chaory et al.2004). The patient's fears, beliefs and avoidance attitudes are predictive of the result and observance of treatment, particularly functional restoration programs (Pfingsten et al. 2000). The FABQ is a self-questionnaire with 16 items rated 0 to 6 on a Likert scale (0 = absolutely disagree, 6 = completely agree) ; the questions focus on the appreciation of notions of apprehension relative to professional activities and other physical activities. It takes about 10 minutes to complete the questionnaire. A high score represents a high rate of fears and beliefs.	Day of consultation, at least 3 years after surgery
Secondary	Lasègue manoeuvre in spinal fusion patients	This provocation test is very specific to radicular sciatica . Raising the lower limb with the knee in extension, reproduces sciatica pain if there is an impression of disk 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.	Day of consultation, at least 3 years after surgery
Secondary	Lasègue manoeuvre in lumbar arthroplasty patients	This provocation test is very specific to radicular sciatica . Raising the lower limb with the knee in extension, reproduces sciatica pain if there is an impression of disk 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.	Day of consultation, at least 3 years after surgery
Secondary	Results of the SF-12 Quality of Life questionnaire in spinal fusion patients	This quality of life self-evaluation scale is a short version of the SF-36 and gives two scores: one mental and social quality of life score, and one physical quality of life score (Ware et al. 1996). For the scoring (1) each answer to 12 items must be converted into standardized values both for the mental and social score and for the physical score, (2) the 12 standardized values obtained for the mental et social score are added together and (3) 60,75781 is added on to get the mental et social quality of life score. Then, the 12 standardized values obtained for the physical score are added together and 56,57706 is added on to get the physical quality of life score.	Day of consultation, at least 3 years after surgery
Secondary	Results of the SF-12 Quality of Life questionnaire in lumbar arthroplasty patients	This quality of life self-evaluation scale is a short version of the SF-36 and gives two scores: one mental and social quality of life score, and one physical quality of life score (Ware et al. 1996). For the scoring (1) each answer to 12 items must be converted into standardized values both for the mental and social score and for the physical score, (2) the 12 standardized values obtained for the mental et social score are added together and (3) 60,75781 is added on to get the mental et social quality of life score. Then, the 12 standardized values obtained for the physical score are added together and 56,57706 is added on to get the physical quality of life score.	Day of consultation, at least 3 years after surgery
Secondary	Results of the Patient Global Impression of Change scale in spinal fusion patients	The Patient Global Impression of Change scale is a self-questionnaire on satisfaction regarding the change brought by the treatment to daily activities, symptoms and quality of life in relation to chronic pain. This scale has been validated in French (Le Gal et al. 2010) and consists of 7 points. The patients are classified into 3 categories according to their score (Rampakakis et al. 2015): deterioration (a score of 1 to 3), stable (score of 4), improvement (score of 5 to 7).	Day of consultation, at least 3 years after surgery
Secondary	Results of the Patient Global Impression of Change scale in lumbar arthroplasty patients	The Patient Global Impression of Change scale is a self-questionnaire on satisfaction regarding the change brought by the treatment to daily activities, symptoms and quality of life in relation to chronic pain. This scale has been validated in French (Le Gal et al. 2010) and consists of 7 points. The patients are classified into 3 categories according to their score (Rampakakis et al. 2015): deterioration (a score of 1 to 3), stable (score of 4), improvement (score of 5 to 7).	Day of consultation, at least 3 years after surgery
Secondary	MRI data acquisition in spinal fusion patients	A 3T MRI scanner (Magnetom Skyra, Siemens Healthcare) equipped with a 32-channel head coil will be used to obtain the following sequences: sagittal proton density-weighted Dixon sequencing on the lumbar spine and axial T2-weighted spin echo sequencing on the lumbar discs.	Day of consultation, at least 3 years after surgery
Secondary	MRI data acquisition in lumbar arthroplasty patients	A 3T MRI scanner (Magnetom Skyra, Siemens Healthcare) equipped with a 32-channel head coil will be used to obtain the following sequences: sagittal proton density-weighted Dixon sequencing on the lumbar spine and axial T2-weighted spin echo sequencing on the lumbar discs.	Day of consultation, at least 3 years after surgery
Secondary	Body Mass Index of spinal fusion patients	The patient's weight and height will be noted in an observation booklet and the patient's body mass index will be calculated via a computer (in kg/m2)	Day of consultation, at least 3 years after surgery
Secondary	Body Mass Index of lumbar arthroplasty patients	The patient's weight and height will be noted in an observation booklet and the patient's body mass index will be calculated via a computer (in kg/m2)	Day of consultation, at least 3 years after surgery