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Completed

NCT Number: NCT03585439

Isthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes

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.

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Key information

Conditions

Isthmic Spondylolisthesis Surgical Procedure, Unspecified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CMC Ambroise Pare

Neuilly-sur-Seine, Île-de-France Region, 92200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  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 outcomes

  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…)

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Official study title

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

Acronym: SPLAC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2018
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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