Spinal InstabilityARBORDNCT03876275
Comparative Study of Arthrodeses by "Single Posterior Approach" and by "Double Anterior and Posterior Approach"
An observational study of Spinal Instability, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Extended arthrodesis of the spine is indicated in the treatment of deformities. The principle of the intervention is to correct the spinal imbalance and to obtain a fusion of the vertebral segment operated in order to guarantee the durability of this correction, in order to guarantee a functional result the best… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Instability
- How many people
- 193 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 11 Sep 2023
- 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: Patients undergoing arthrodesis including the sacrum and extending to T11 or greater
Who may be able to join
- Patient whose age ≥ 18 years
- Patient operated on an arthrodesis including the sacrum and extending to T11 or greater
- Francophone patient
- Patient not opposing his participation in the research protocol
Who cannot join
- Patient under tutorship or curatorship
- Patient deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Arthrodeses in One Time by "Single Posterior Approach" and Two-stage Arthrodeses by "Double Anterior and Posterior Approach"
Extended arthrodesis of the spine is indicated in the treatment of deformities. The principle of the intervention is to correct the spinal imbalance and to obtain a fusion of the vertebral segment operated in order to guarantee the durability of this correction, in order to guarantee a functional result the best possible one.
There is a great disparity in the techniques available to obtain this result: as regards the correction of the deformation itself, it is possible to resort to various types of gestures aimed at "freeing" the spine to allow the getting the correction. It may be staged or transpedicular osteotomies or previous releases (staged discectomies). Regarding the arthrodesis itself, this can be obtained by an isolated posterior graft or by a circumferential graft itself performed in a time using interbody cages PLIF type (posterior lumbar interbody fusion) or TLIF (transforaminal interbody fusion) or in two stages by a complementary anterior graft. These are heavy interventions with a high complication rate.
Read more
The choice of this or that technique is based on data from the literature and remains at the discretion of the surgeon who makes the surgical indication. However, it has never been possible to compare these different techniques in a prospective study. The few articles comparing the different techniques tend to show that there is no significant difference between the techniques with a higher complication rate for the two-step techniques. However, these are retrospective studies, with all the biases that this implies and despite these results the disparity in surgical indications remains substantial.
The objective of this work is therefore to evaluate, according to an identical protocol, the different surgical techniques for the treatment of spinal deformities associated with a fusion in order to determine the morbidity associated with each of the techniques and if this morbidity is justified by a better functional result at a minimum follow-up of two years.
- Conditions
- Spinal Instability
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical revision rate
Surgical revision rate following double-approach techniques and single posterior approach techniques
Measured: year 2
Secondary outcomes (11)
duration of the procedure
duration of the procedure
Measured: Day 1
bleeding during the procedure
bleeding volume during the procedure
Measured: Day 1
quality of life questionnary Oswestry v2
The quality of life questionnary Oswestry v2 before surgery corresponds to the score 0% -20%: Minimal disability; 21%-40%: Moderate Disability; 41%-60%: Severe Disability; 61%-80%: Crippling back pain and 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Measured: Day 0
quality of life questionnary SF-12
The quality of life questionnary SF-12 before surgery corresponds to a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).
Measured: Day 0
Visual Analog Score for pain
The visual Analog Score for pain before surgery corresponds to a score between 0 to 10.
Measured: Day 0
quality of life questionnary Oswestry v2
The quality of life questionnary Oswestry v2 one year after surgery corresponds to the score 0% -20%: Minimal disability; 21%-40%: Moderate Disability; 41%-60%: Severe Disability; 61%-80%: Crippling back pain and 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Measured: year 1
quality of life questionnary SF-12
The quality of life questionnary SF-12 one year after surgery to a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).
Measured: year 1
Visual Analog Score for pain
The pain evaluation with Visual analogue scale one year after surgery corresponds to a score between 0 to 10.
Measured: year 1
quality of life questionnary Oswestry v2
The quality of life questionnary Oswestry v2 two years after surgery corresponds to the score 0% -20%: Minimal disability; 21%-40%: Moderate Disability; 41%-60%: Severe Disability; 61%-80%: Crippling back pain and 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Measured: year 2
quality of life questionnary SF-12
The quality of life questionnary SF-12 two years after surgery to a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).
Measured: year 2
Visual Analog Score for pain
The pain evaluation with Visual analogue scale two years after surgery corresponds to a score between 0 to 10.
Measured: year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Mar 2019
- Primary completion3 Mar 2021
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume RIOUALLON, MD, Study director, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876275
- Sponsor's protocol ID
- ARBORD
- Acronym
- ARBORD
- Status last verified
- Sep 2023
- First submitted
- 7 Mar 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Arthrodeses in One Time by "Single Posterior Approach" and Two-stage Arthrodeses by "Double Anterior and Posterior Approach"
- ClinicalTrials.gov ID
- NCT03876275
- Acronym / sponsor ID
- ARBORD / ARBORD
- Conditions
- Spinal Instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Extended arthrodesis of the spine is indicated in the treatment of deformities. The principle of the intervention is to correct the spinal imbalance and to obtain a fusion of the vertebral segment operated in order to guarantee the durability of this correction, in order to guarantee a functional result the best possible one.
There is a great disparity in the techniques available to obtain this result: as regards the correction of the deformation itself, it is possible to resort to various types of gestures aimed at "freeing" the spine to allow the getting the correction. It may be staged or transpedicular osteotomies or previous releases (staged discectomies). Regarding the arthrodesis itself, this can be obtained by an isolated posterior graft or by a circumferential graft itself performed in a time using interbody cages PLIF type (posterior lumbar interbody fusion) or TLIF (transforaminal interbody fusion) or in two stages by a complementary anterior graft. These are heavy interventions with a high complication rate.
The choice of this or that technique is based on data from the literature and remains at the discretion of the surgeon who makes the surgical indication. However, it has never been possible to compare these different techniques in a prospective study. The few articles comparing the different techniques tend to show that there is no significant difference between the techniques with a higher complication rate for the two-step techniques. However, these are retrospective studies, with all the biases that this implies and despite these results the disparity in surgical indications remains substantial.
The objective of this work is therefore to evaluate, according to an identical protocol, the different surgical techniques for the treatment of spinal deformities associated with a fusion in order to determine the morbidity associated with each of the techniques and if this morbidity is justified by a better functional result at a minimum follow-up of two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing arthrodesis including the sacrum and extending to T11 or greater
Key inclusion criteria (4 listed)
- Patient whose age ≥ 18 years
- Patient operated on an arthrodesis including the sacrum and extending to T11 or greater
- Francophone patient
- Patient not opposing his participation in the research protocol
Key exclusion criteria (2 listed)
- Patient under tutorship or curatorship
- Patient deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical revision rate
Time frame: year 2
Surgical revision rate following double-approach techniques and single posterior approach techniques
11 secondary outcomes
duration of the procedure
Time frame: Day 1
bleeding during the procedure
Time frame: Day 1
quality of life questionnary Oswestry v2
Time frame: Day 0
quality of life questionnary SF-12
Time frame: Day 0
Visual Analog Score for pain
Time frame: Day 0
quality of life questionnary Oswestry v2
Time frame: year 1
quality of life questionnary SF-12
Time frame: year 1
Visual Analog Score for pain
Time frame: year 1
quality of life questionnary Oswestry v2
Time frame: year 2
quality of life questionnary SF-12
Time frame: year 2
Visual Analog Score for pain
Time frame: year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume RIOUALLON, MD study director
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Instability, run by Fondation Hôpital Saint-Joseph 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 13 Sep 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surgical revision rate (time frame: year 2). 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 13 Sep 2023.