Comparative Study of Arthrodeses by "Single Posterior Approach" and by "Double Anterior and Posterior Approach" (ARBORD)

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.

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 Overview

• Status: Completed
• Conditions: Spinal Instability

• Study Type: Observational
• Enrollment (Actual): 193

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing arthrodesis including the sacrum and extending to T11 or greater

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient under tutorship or curatorship
• Patient deprived of liberty

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical revision rate	Surgical revision rate following double-approach techniques and single posterior approach techniques	year 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of the procedure	duration of the procedure	Day 1
bleeding during the procedure	bleeding volume during the procedure	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.	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).	Day 0
Visual Analog Score for pain	The visual Analog Score for pain before surgery corresponds to a score between 0 to 10.	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.	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).	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.	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.	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).	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.	year 2

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph
• Investigators: Study Director: Guillaume RIOUALLON, MD, Fondation Hôpital Saint-Joseph

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 3, 2021
• Study Completion (Actual): September 11, 2023

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ARBORD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No