Clinical trial NCT03876275: Comparative Study of Arthrodeses by "Single Posterior Approach" and by "Double Anterior and Posterior Approach"
Official title: Comparative Study of Arthrodeses in One Time by "Single Posterior Approach" and Two-stage Arthrodeses by "Double Anterior and Posterior Approach"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Instability
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing arthrodesis including the sacrum and extending to T11 or greater

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Surgical revision rate
timeFrame: year 2
Secondary outcomes:
measure: duration of the procedure
timeFrame: Day 1
measure: bleeding during the procedure
timeFrame: Day 1
measure: quality of life questionnary Oswestry v2
timeFrame: Day 0
measure: quality of life questionnary SF-12
timeFrame: Day 0
measure: Visual Analog Score for pain
timeFrame: Day 0
measure: quality of life questionnary Oswestry v2
timeFrame: year 1
measure: quality of life questionnary SF-12
timeFrame: year 1
measure: Visual Analog Score for pain
timeFrame: year 1
measure: quality of life questionnary Oswestry v2
timeFrame: year 2
measure: quality of life questionnary SF-12
timeFrame: year 2
measure: Visual Analog Score for pain
timeFrame: year 2
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Guillaume RIOUALLON, MD
role: STUDY_DIRECTOR
References: