Isthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes

Surgical Procedure, Unspecified Clinical Trial

— SPLAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585439
• Other study ID #: 2018/06
• Status: Completed
• Start date: June 28, 2018
• Est. completion date: November 28, 2018

Study information

• Verified date: April 2019
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Isthmic Spondylolisthesis
• Spondylolisthesis
• Surgical Procedure, Unspecified

Intervention

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.

Locations

Country	Name	City	State
France	CMC Ambroise Pare	Neuilly-sur-Seine	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complication rate	intra-operative, early and late post-operative complications (vascular injury, non-union, infection, etc…)	until 1 year after surgery