NCT03876275: ARBORD

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

Completed Last updated 13 September 2023

What this trial tests

trial in Spinal Instability in 193 participants. Completed in 11 September 2023.

Timeline

1 March 2019

Primary endpoint
3 March 2021

11 September 2023

Quick facts

Lead sponsor	Fondation Hôpital Saint-Joseph
Status	Completed
Study type	OBSERVATIONAL
Enrollment	193
Start date	1 March 2019
Primary completion	3 March 2021
Estimated completion	11 September 2023
Sites	1 location across France

Conditions studied

• Spinal Instability — all drugs for Spinal Instability →

Sponsor

Fondation Hôpital Saint-Joseph — full company profile →

Who can join

18 and older, any sex, with Spinal Instability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.