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

NCT03876275 | Completed

• 1 other identifier: ARBORD
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Instability

Outcome Measures

Primary Outcomes (1)

• Surgical revision rate

  Surgical revision rate following double-approach techniques and single posterior approach techniques

  year 2

Secondary Outcomes (11)

• duration of the procedure

  Day 1

• bleeding during the procedure

  Day 1

• quality of life questionnary Oswestry v2

  Day 0

• quality of life questionnary SF-12

  Day 0

• Visual Analog Score for pain

  Day 0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patient under tutorship or curatorship
• Patient deprived of liberty

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Study Officials

• Guillaume RIOUALLON, MD

  Fondation Hôpital Saint-Joseph

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 15, 2019
• Study Start: March 1, 2019
• Primary Completion: March 3, 2021
• Study Completion: September 11, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

FR (1)