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Spine SurgeryARTHRO-DEGENCT05561322

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

An observational study of Spine Surgery, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spine Surgery
What is being tested?
Consultation involving pain evaluation, questionnaires and the Lasègue Manoeuver and Magnetic Resonance Imaging of the lumbar spine
How many people
0 participants
Where
1 siteFrance
Study dates
27 Feb 2024to 27 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Nîmes University Hospital

    Nîmes, Gard, 30029

Other trials in France

About this study

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.

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.

Read the 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
Being tested
Consultation involving pain evaluation, questionnaires and the Lasègue Manoeuver, Magnetic Resonance Imaging of the lumbar spine
Keywords
Arthroplasty, Arthrodesis, Disc degeneration, Lumbar spine, Spinal fusion
Medical subject headings
Ankylosis, Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Consultation involving pain evaluation, questionnaires and the Lasègue ManoeuverOther

    Also called 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 spineOther

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

Study groups in NCT05561322
Study groupRoleWhat they receive
Spinal fusion patientsPatients who have undergone spinal fusion surgery and have had at least 3 years of follow-up.
Receives: Other: Consultation involving pain evaluation, questionnaires and the Lasègue Manoeuver; Other: Magnetic Resonance Imaging of the lumbar spine
Lumbar arthroplasty patientsPatients who have undergone lumbar arthroplasty with disc replacement and have had at least 3 years of follow-up.
Receives: Other: Consultation involving pain evaluation, questionnaires and the Lasègue Manoeuver; Other: Magnetic Resonance Imaging of the lumbar spine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day of consultation, at least 3 years after the initial surgery

  2. 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.

    Measured: Day of consultation, at least 3 years after surgery

Secondary outcomes (28)
  1. 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.

    Measured: Day of consultation, at least 3 years after surgery

  2. 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.

    Measured: Day of consultation, at least 3 years after surgery

  3. 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.

    Measured: Day of consultation, at least 3 years after surgery

  4. 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.

    Measured: Day of consultation, at least 3 years after surgery

  5. 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.

    Measured: Day of consultation, at least 3 years after surgery

  6. 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.

    Measured: Day of consultation, at least 3 years after surgery

  7. 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

    Measured: Day of consultation, at least 3 years after surgery

  8. 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

    Measured: Day of consultation, at least 3 years after surgery

  9. 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.

    Measured: Day of consultation, at least 3 years after surgery

  10. 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

    Measured: Day of consultation, at least 3 years after surgery

  11. Re-intervention rate among spinal fusion patients

    The number of re-interventions among spinal fusion patients will be recorded as a percentage.

    Measured: Day of consultation, at least 3 years after surgery

  12. Re-intervention rate among lumbar arthroplasty patients

    The number of re-interventions among lumbar arthroplasty patients will be recorded as a percentage.

    Measured: Day of consultation, at least 3 years after surgery

  13. 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.

    Measured: Day of consultation, at least 3 years after surgery

  14. 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.

    Measured: Day of consultation, at least 3 years after surgery

  15. 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).

    Measured: Day of consultation, at least 3 years after surgery

  16. 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).

    Measured: Day of consultation, at least 3 years after surgery

  17. 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.

    Measured: Day of consultation, at least 3 years after surgery

  18. 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.

    Measured: Day of consultation, at least 3 years after surgery

  19. 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.

    Measured: Day of consultation, at least 3 years after surgery

  20. 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.

    Measured: Day of consultation, at least 3 years after surgery

  21. 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.

    Measured: Day of consultation, at least 3 years after surgery

  22. 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.

    Measured: Day of consultation, at least 3 years after surgery

  23. 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).

    Measured: Day of consultation, at least 3 years after surgery

  24. 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).

    Measured: Day of consultation, at least 3 years after surgery

  25. 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.

    Measured: Day of consultation, at least 3 years after surgery

  26. 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.

    Measured: Day of consultation, at least 3 years after surgery

  27. 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)

    Measured: Day of consultation, at least 3 years after surgery

  28. 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)

    Measured: Day of consultation, at least 3 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2022
  2. Study start27 Feb 2024
  3. Primary completion27 Feb 2024
  4. Study completion27 Feb 2024

Why it stopped: never started

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05561322
Sponsor's protocol ID
NIMAO/2018-02/PK-01
Other IDs
RCB no.
Acronym
ARTHRO-DEGE
Status last verified
Feb 2024
First submitted
27 Sep 2022
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spine Surgery, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of adjacent segment disc degeneration in spinal fusion patients (time frame: Day of consultation, at least 3 years after the initial surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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