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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
Sponsor:
Information provided by (Responsible Party):
CMC Ambroise Paré

Brief 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.

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

Detailed 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.

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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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.

  8. Complication rate [ Time Frame: until 1 year after surgery ]
    intra-operative, early and late post-operative complications (vascular injury, non-union, infection, etc…)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive cohort of patients operated in our center from 2013 to 2017
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
CMC Ambroise Pare
Neuilly-sur-Seine, Ile-de-France, France, 92200
Sponsors and Collaborators
CMC Ambroise Paré

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Responsible Party: CMC Ambroise Paré
ClinicalTrials.gov Identifier: NCT03585439     History of Changes
Other Study ID Numbers: 2018/06
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CMC Ambroise Paré:
Isthmic spondylolisthesis
vertebral fusion
combined approach
circumferential fusion
ALIF
posterior fusion

Additional relevant MeSH terms:
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Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases