Isthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes

NCT03585439 | Completed

• 1 other identifier: 2018/06
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate clinical and radiological outcomes of isthmic spondylolisthesis surgically treated with combined approach. The goal is to demonstrate that it is a safe and efficient technique to treat isthmic spondylolisthesis. There is very little literature concerning this procedure.

Conditions

Isthmic Spondylolisthesis; Surgical Procedure, Unspecified

Keywords

Isthmic spondylolisthesis; vertebral fusion; combined approach; circumferential fusion; ALIF; posterior fusion

Outcome Measures

Primary Outcomes (1)

• Fusion status

  Every patient has a CT-Scan of the lumbar spine done to check fusion status. The interpretation is made by the surgeon who did the surgery and one independent reviewer.

  From 6 months to 1 year after surgery

Secondary Outcomes (8)

• Restoration of the foraminal diameter

  3 months and 1 year after surgery

• Correction of the spondylolisthesis-induced kyphosis after surgery

  3 months and 1 year after surgery

• Segmental lordosis

  3 months and 1 year after surgery

• Local Lordosis

  3 months and 1 year after surgery

• Back pain

  Pre-operative, 3 months and 1 year after surgery

Study Arms (1)

Single cohort of operated patients

One group of patients: isthmic spondylolisthesis operated in our center using a double approach technique

Procedure: Observational study evaluating the results of an intervention for isthmic spondylolisthesis: surgical procedure with double approach: Anterior lumbar Interbody Fusion then postero-lateral fusion

Interventions

Observational study evaluating the results of an intervention for isthmic spondylolisthesis: surgical procedure with double approach: Anterior lumbar Interbody Fusion then postero-lateral fusion PROCEDURE

First in supine position, an ALIF is performed: with a Pfannenstiel incision, through a retroperitoneal approach, a discectomy is performed at the level of the spondylolisthesis then a cage is placed between the two vertebral bodies. Then, in prone position, a standard posterior approach is performed, pedicle screws are placed to achieve a postero-lateral fusion. A decompression may be associated.

Single cohort of operated patients

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

Consecutive cohort of patients operated in our center from 2013 to 2017

You may qualify if:

• All patients aged over 18 years
• With isthmic spondylolisthesis at L4-L5 or L5-S1
• Operated in our center with a double approach: Anterior lumbar interbody fusion then postero-lateral fusion
• Consent for participation

You may not qualify if:

• Pseudarthrosis L5-S1

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

CMC Ambroise Pare

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

Related Publications (1)

• Khalife M, Dauzac C, Lenoir T, Magrino B. Isthmic spondylolisthesis treated with circumferential arthrodesis (ALIF and posterior fixation): correction, fusion and indirect decompression. Acta Orthop Belg. 2021 Dec;87(4):787-794. doi: 10.52628/87.4.27.

  PMID: 35172449 RESULT

Study Design

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

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 13, 2018
• Study Start: June 28, 2018
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)