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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03585439
Other study ID # 2018/06
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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