Isthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes (SPLAC)

Isthmic Spondylolisthesis Treated With Circumferential Arthrodesis Combining Anterior Lumbar Interbody Fusion With Posterolateral Fusion. About 150 Cases

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.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified; Isthmic Spondylolisthesis
• Intervention / Treatment: 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

Detailed Description

Isthmic spondylolisthesis can cause back and leg pain. If pain persists after well conducted medical management, a surgical treatment can be proposed. Even though the goal is consensual, there are plenty of ways to reach vertebral fusion: ALIF, PLIF, TLIF, Posterior fusion only, etc… 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 using standard XRays, CT Scan and patient reported outcome measurements. There is very little literature concerning this procedure.

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Neuilly-sur-Seine, Île-de-France Region, France, 92200
      • CMC Ambroise Paré

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

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pseudarthrosis L5-S1

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration of the foraminal diameter	The foraminal diameter is measured to quantify the restoration of the foraminal diameter after surgery, making more room for the nerve root.	3 months and 1 year after surgery
Correction of the spondylolisthesis-induced kyphosis after surgery	The lumbo-sacral angle is measured to quantify the correction of the spondylolisthesis-induced kyphosis after surgery.	3 months and 1 year after surgery
Segmental lordosis	Segmental lordosis is measured with the L5-S1 lordosis, quantifying the correction at the spondylolisthesis level	3 months and 1 year after surgery
Local Lordosis	Local Lordosis measured with the L4-S1 lordosis, quantifying the correction in the lower lumbar region	3 months and 1 year after surgery
Back pain	Measured with Lumbar Visual Analogic Scale. The patient quantifies his back pain with a number, ranging from 0 to 10 (0 = no pain, 10= worst possible pain)	Pre-operative, 3 months and 1 year after surgery
Sciatica	Measured with Radicular Visual Analogic Scale. The patient quantifies his leg pain with a number, ranging from 0 to 10 (0 = no pain, 10= worst possible pain)	Pre-operative, 3 months and 1 year after surgery
Disability	Measured with the ODI (Oswestry Disability Index). The patient answers 10 questions concerning his daily life and the disability caused by his back problem, giving a global score. 0 is equated with no disability and 100 is the maximum disability possible.	Pre-operative, 3 months and 1 year after surgery
Complication rate	intra-operative, early and late post-operative complications (vascular injury, non-union, infection, etc…)	until 1 year after surgery

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): November 28, 2018
• Study Completion (Actual): November 28, 2018

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Isthmic spondylolisthesis; vertebral fusion; combined approach; circumferential fusion; ALIF; posterior fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: 2018/06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No