Isthmic SpondylolisthesisSPLACNCT03585439
Isthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes
An observational study of Isthmic Spondylolisthesis and Surgical Procedure, Unspecified, run by CMC Ambroise Paré at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Isthmic Spondylolisthesis, Surgical Procedure, Unspecified
- What is being tested?
- Observational study evaluating the results of an intervention for isthmic spondylolisthesis: surgical procedure with double approach: Anterior lumbar Interbody Fusion then postero-lateral fusion
- Type of treatment
- Surgery or procedure
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2018to 28 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive cohort of patients operated in our center from 2013 to 2017
Who may be able to join
- 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
Who cannot join
- Pseudarthrosis L5-S1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isthmic Spondylolisthesis Treated With Circumferential Arthrodesis Combining Anterior Lumbar Interbody Fusion With Posterolateral Fusion. About 150 Cases
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.
Read the 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.
- Being tested
- Observational study evaluating the results of an intervention for isthmic spondylolisthesis: surgical procedure with double approach: Anterior lumbar Interbody Fusion then postero-lateral fusion
- Keywords
- Isthmic spondylolisthesis, vertebral fusion, combined approach, circumferential fusion, ALIF, posterior fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study evaluating the results of an intervention for isthmic spondylolisthesis: surgical procedure with double approach: Anterior lumbar Interbody Fusion then postero-lateral fusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort of operated patients | One group of patients: isthmic spondylolisthesis operated in our center using a double approach technique Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 6 months to 1 year after surgery
Secondary outcomes (8)
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.
Measured: 3 months and 1 year after surgery
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.
Measured: 3 months and 1 year after surgery
Segmental lordosis
Segmental lordosis is measured with the L5-S1 lordosis, quantifying the correction at the spondylolisthesis level
Measured: 3 months and 1 year after surgery
Local Lordosis
Local Lordosis measured with the L4-S1 lordosis, quantifying the correction in the lower lumbar region
Measured: 3 months and 1 year after surgery
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)
Measured: Pre-operative, 3 months and 1 year after surgery
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)
Measured: Pre-operative, 3 months and 1 year after surgery
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.
Measured: Pre-operative, 3 months and 1 year after surgery
Complication rate
intra-operative, early and late post-operative complications (vascular injury, non-union, infection, etc…)
Measured: until 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start28 Jun 2018
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Isthmic SpondylolisthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585439
- Sponsor's protocol ID
- 2018/06
- Acronym
- SPLAC
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2018
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khalife M, Dauzac C, Lenoir T, Magrino B. Isthmic spondylolisthesis treated with circumferential arthrodesis (ALIF and posterior fixation): correction, fusion and indirect decompression. Acta Orthop Belg. 2021 Dec;87(4):787-794. doi: 10.52628/87.4.27.
PubMed 35172449
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isthmic Spondylolisthesis Treated With Circumferential Arthrodesis Combining Anterior Lumbar Interbody Fusion With Posterolateral Fusion. About 150 Cases
- ClinicalTrials.gov ID
- NCT03585439
- Acronym / sponsor ID
- SPLAC / 2018/06
- Keywords
- Isthmic spondylolisthesis, vertebral fusion, combined approach, circumferential fusion, ALIF, posterior fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort of operated patients | – | Procedure: Observational study evaluating the results of an intervention for isthmic spondylolisthesis: surgical procedure with double approach: Anterior lumbar Interbody Fusion then postero-lateral fusionOne group of patients: isthmic spondylolisthesis operated in our center using a double approach technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive cohort of patients operated in our center from 2013 to 2017
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pseudarthrosis L5-S1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study evaluating the results of an intervention for isthmic spondylolisthesis: surgical procedure with double approach: Anterior lumbar Interbody Fusion then postero-lateral fusionFirst 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. | Procedure or surgery | Single cohort of operated patients |
Primary outcome
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.
8 secondary outcomes
Restoration of the foraminal diameter
Time frame: 3 months and 1 year after surgery
Correction of the spondylolisthesis-induced kyphosis after surgery
Time frame: 3 months and 1 year after surgery
Segmental lordosis
Time frame: 3 months and 1 year after surgery
Local Lordosis
Time frame: 3 months and 1 year after surgery
Back pain
Time frame: Pre-operative, 3 months and 1 year after surgery
Sciatica
Time frame: Pre-operative, 3 months and 1 year after surgery
Disability
Time frame: Pre-operative, 3 months and 1 year after surgery
Complication rate
Time frame: until 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Results publication: PubMed 35172449Khalife M, Dauzac C, Lenoir T, Magrino B. Isthmic spondylolisthesis treated with circumferential arthrodesis (ALIF and posterior fixation): correction, fusion and indirect decompression. Acta Orthop Belg. 2021 Dec;87(4):787-794. doi: 10.52628/87.4.27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isthmic Spondylolisthesis and Surgical Procedure, Unspecified, run by CMC Ambroise Paré at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion status (time frame: From 6 months to 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03585439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.