Isthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes

NCT ID: NCT03585439

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-28

Study Completion Date

2018-11-28

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.

Conditions

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Isthmic Spondylolisthesis Surgical Procedure, Unspecified

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Single cohort of operated patients

One group of patients: isthmic spondylolisthesis operated in our center using a double approach technique

Observational study evaluating the results of an intervention for isthmic spondylolisthesis: surgical procedure with double approach: Anterior lumbar Interbody Fusion then postero-lateral fusion

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CMC Ambroise Paré

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CMC Ambroise Pare

Neuilly-sur-Seine, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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2018/06

Identifier Type: -

Identifier Source: org_study_id

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