Isthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Isthmic Spondylolisthesis, Surgical Procedure, Unspecified

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single cohort of operated patients<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALIF, Isthmic spondylolisthesis, vertebral fusion, combined approach, circumferential fusion, posterior fusion