Skip to content

Isthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03585439
Acronym
SPLAC
Enrollment
87
Registered
2018-07-13
Start date
2018-06-28
Completion date
2018-11-28
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Isthmic Spondylolisthesis, Surgical Procedure, Unspecified

Keywords

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

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.

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.

Interventions

PROCEDUREObservational 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.

Sponsors

CMC Ambroise Paré
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fusion statusFrom 6 months to 1 year after surgeryEvery 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.

Secondary

MeasureTime frameDescription
Restoration of the foraminal diameter3 months and 1 year after surgeryThe foraminal diameter is measured to quantify the restoration of the foraminal diameter after surgery, making more room for the nerve root.
Correction of the spondylolisthesis-induced kyphosis after surgery3 months and 1 year after surgeryThe lumbo-sacral angle is measured to quantify the correction of the spondylolisthesis-induced kyphosis after surgery.
Segmental lordosis3 months and 1 year after surgerySegmental lordosis is measured with the L5-S1 lordosis, quantifying the correction at the spondylolisthesis level
Local Lordosis3 months and 1 year after surgeryLocal Lordosis measured with the L4-S1 lordosis, quantifying the correction in the lower lumbar region
Back painPre-operative, 3 months and 1 year after surgeryMeasured 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)
SciaticaPre-operative, 3 months and 1 year after surgeryMeasured 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)
DisabilityPre-operative, 3 months and 1 year after surgeryMeasured 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.
Complication rateuntil 1 year after surgeryintra-operative, early and late post-operative complications (vascular injury, non-union, infection, etc…)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026