Isthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes (SPLAC)
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|ClinicalTrials.gov Identifier: NCT03585439|
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment|
|Isthmic Spondylolisthesis Surgical Procedure, Unspecified||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|
|Study Type :||Observational|
|Actual Enrollment :||87 participants|
|Official Title:||Isthmic Spondylolisthesis Treated With Circumferential Arthrodesis Combining Anterior Lumbar Interbody Fusion With Posterolateral Fusion. About 150 Cases|
|Actual Study Start Date :||June 28, 2018|
|Actual Primary Completion Date :||November 28, 2018|
|Actual Study Completion Date :||November 28, 2018|
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.
- Fusion status [ Time Frame: From 6 months to 1 year after surgery ]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.
- Restoration of the foraminal diameter [ Time Frame: 3 months and 1 year after surgery ]The 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 surgery [ Time Frame: 3 months and 1 year after surgery ]The lumbo-sacral angle is measured to quantify the correction of the spondylolisthesis-induced kyphosis after surgery.
- Segmental lordosis [ Time Frame: 3 months and 1 year after surgery ]Segmental lordosis is measured with the L5-S1 lordosis, quantifying the correction at the spondylolisthesis level
- Local Lordosis [ Time Frame: 3 months and 1 year after surgery ]Local Lordosis measured with the L4-S1 lordosis, quantifying the correction in the lower lumbar region
- Back pain [ Time Frame: Pre-operative, 3 months and 1 year after surgery ]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)
- Sciatica [ Time Frame: Pre-operative, 3 months and 1 year after surgery ]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)
- Disability [ Time Frame: Pre-operative, 3 months and 1 year after surgery ]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.
- Complication rate [ Time Frame: until 1 year after surgery ]intra-operative, early and late post-operative complications (vascular injury, non-union, infection, etc…)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585439
|CMC Ambroise Pare|
|Neuilly-sur-Seine, Ile-de-France, France, 92200|