Degenerative SpondylolisthesisSPONGITNCT00869882
SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis
A study testing Circumferential arthrodesis and Posterolateral fusion with instrumentation in people with Degenerative Spondylolisthesis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Degenerative Spondylolisthesis
- What is being tested?
- Circumferential arthrodesis and Posterolateral fusion with instrumentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Nov 2013
- Phase
- Interventional
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged less than 75,
- Having been informed about clinical trial objectives and risk,
- Covered by health insurance system,
- Suffering from degenerative spondylolisthesis (whatever the grade and intervertebral disc height) needing one-level surgical fusion due to either invalidating lombalgia/radiculalgia despite 6-month optimal medical treatment and/or motor neurological symptoms.
Who cannot join
- Previous lumbar fusion,
- Previous spine traumatism,
- Presence of at least one major contraindication to surgery and/or general anaesthesia (ie, non controlled coagulopathy, active infection, or serious underlying disease, auto-immune affection).
- Presence of at least one contraindication to either TLIF or GPLI,
- Severe radiological osteoporosis.
- Active cancer at time of inclusion into the study.
- Unlikely to comply with the requirements of the study and/or to complete the study for psychological, social, familial or geographical reasons.
- Under any administrative or legal supervision.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de chirurgie orthopédique, Hôpital Pellegrin Tripode
Bordeaux, 33076
About this study
Official title: Comparison of 2 Surgical Approaches in the Treatment of Degenerative Spondylolysthesis: Posterolateral Fusion With Instrumentation (GPLI) Plus or Minus Transforaminal Lumbar Interbody Fusion (TLIF)
This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion.
Read the detailed description
Degenerative spondylolisthesis is defined as the slip of one vertebra onto the other due to degenerative lesions; the L4-L5 intervertebral space is mainly involved. Mean age of symptomatic disease is about 60. Surgery is indicated in the presence of radiculalgia and/or neurological claudication and/or invalidating lombalgia, worsening neurological deficit, presence of sphincterian incontinence.
Surgical treatment of degenerative spondylolisthesis usually consists in neural decompression followed by posterolateral fusion with instrumentation. In the literature, fusion rate is estimated to be 80% with GPLI and seems to be increased by interbody fusion, especially transforaminal lumbar interbody fusion which has the advantage of unilateral disc interspace route, and fusion rate over 90%.
It seems that hypolordosis in the instrumented segments caused increased loading of the posterior column in the adjacent segments. These biomechanical effects may explain the degenerative changes at the junction level that have been observed as long-term consequences of lumbar fusion.
In addition to fusion, segmental lordosis gain seems to be an important long-term prognostic factor. Segmental lordosis recovery (upper than 3° in order to take into account measurement variability), was never assessed after TLIF procedure nor compared to that after posterolateral fusion in controlled randomized clinical trials.
The main objective of the study is the comparison of efficacy between circumferential fusion (TLIF plus GPLI) and GPLI alone as surgical treatment of degenerative spondylolisthesis in term of "Success" rate, defined as fusion and at least 3-degree increase of segmental lordosis angle, 24 months after surgery.
In this trial, included patients will be randomly assigned to undergo either posterolateral fusion with instrumentation (GPLI) or circumferential fusion with transforaminal lumbar interbody fusion (TLIF) combined to GPLI. In both arms, bone autograft will be performed using loose fragments obtained during neurological decompression.
Six visits are planned during the study: pre-inclusion visit within 3 months before surgery, inclusion/randomisation on the day before surgery, 3 follow-up visits (2, 6, and 12 months after surgery) and an end of study visit 24 months after surgery (or at time of withdrawal if relevant). Hospital stay (about one week, on average) is planned after surgery.
- Conditions
- Degenerative Spondylolisthesis
- Being tested
- Circumferential arthrodesis, Posterolateral fusion with instrumentation
- Keywords
- Spondylolisthesis, degeneration, spinal fusion
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumferential arthrodesisProcedure or surgery
Also called TLIF+GPLI
Patients are carefully positioned in the proned position and submitted to a posterior surgical approach under general anaesthesia. Surgical levels are viewed laterally by mean of intraoperative radiographs which can be performed at surgeon's demand during the whole surgery time.
The preceding procedure is performed. In case of foraminal stenosis, decompression is performed at the same time as discal approach via the narrowest foramen.
In addition to this, before preparation of bed for bone grafting, nerve roots are retracted and the disc nucleus is removed entirely, then endplate decortication is performed. The disc space is distracted. The most anterior part of the disc space is packed with cancellous bone. A cage packed with bone is inserted into the anterior portion of the interspace. According to cage location, bone graft could be inserted in the posterior portion of the interspace. Cage placement is radiologically checked.
The end of the procedure is the same as for GPLI.
Posterolateral fusion with instrumentationProcedure or surgery
Also called GPLI
Patients are carefully positioned in pronation and submitted to a posterior surgical approach under general anaesthesia. Surgical levels are viewed laterally by mean of intraoperative radiographs performed at surgeon's demand during the whole surgery time.
Pedicle screw instrumentation is performed, followed by posterior neural decompression depending on the type of stenosis:
- Central stenosis: decompression is performed including medial facectomy, laminectomy;
- Foraminal stenosis: foraminotomy is performed, while preserving a graft bed as large as possible;
- Pure foraminal stenosis: spinal duct is not opened. Local bone is harvested from the lamina and the spinous process and carefully fragmented for autologous graft.
Subperiosteal dissection is performed between the transverse processes and lateral aspects of the facet joints.
Two rods are placed and locked on screws in maximum compression to optimize segmental lordosis.
Bone autograft is placed into this bed.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Posterolateral fusion with instrumentation combined to transforaminal lumbar interbody fusion Receives: Procedure: Circumferential arthrodesis |
| 2 | Active comparator | Posterolateral fusion with instrumentation Receives: Procedure: Posterolateral fusion with instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate defined as fusion associated to at least a 3-degree increase of segmental lordosis angle and the absence of a reintervention due to a failure of the initial intervention
Measured: 24 months after surgery
Secondary outcomes (7)
Major complication (ie, life threatening haemorrhage, severe and persisting neurological worsening, deep infection) rate, and minor complication rate
Measured: within 24 months after surgery
Success rate defined as both fusion and at least 3-degree increase of segmental lordosis angle
Measured: 6 and 12 months after surgery
Lumbar and radicular pain outcome
Measured: 2, 6, 12 and 24 months after surgery
Functional outcome: Oswestry Disability Index and modified Prolo Economic and Functional scores
Measured: 2, 6, 12 and 24 months after surgery
Change of pelvic and radiological parameters (ie, lumbar lordosis angle, medial intervertebral space height
Measured: 2, 6, 12 and 24 months after surgery
Quality of life outcome: SF-36
Measured: 2, 6, 12 and 24 months after surgery
Per and post operative surgery parameters (ie, operative time, blood loss, hospitalization stay duration)
Measured: within hospital stay due to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Degenerative SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick GUERIN, MD, Principal investigator, University Hospital Bordeaux, FranceAntoine BENARD, MD, Study chair, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869882
- Sponsor's protocol ID
- CHUBX 2008/33
- Other IDs
- 2008-A01645-50
- Acronym
- SPONGIT
- Status last verified
- Oct 2014
- First submitted
- 25 Mar 2009
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosenberg NJ. Degenerative spondylolisthesis. Predisposing factors. J Bone Joint Surg Am. 1975 Jun;57(4):467-74.
PubMed 1141255Frymoyer JW. Degenerative Spondylolisthesis: Diagnosis and Treatment. J Am Acad Orthop Surg. 1994 Jan;2(1):9-15. doi: 10.5435/00124635-199401000-00002.
PubMed 10708989Cummins J, Lurie JD, Tosteson TD, Hanscom B, Abdu WA, Birkmeyer NJ, Herkowitz H, Weinstein J. Descriptive epidemiology and prior healthcare utilization of patients in the Spine Patient Outcomes Research Trial's (SPORT) three observational cohorts: disc herniation, spinal stenosis, and degenerative spondylolisthesis. Spine (Phila Pa 1976). 2006 Apr 1;31(7):806-14. doi: 10.1097/01.brs.0000207473.09030.0d.
PubMed 16582855Taylor VM, Deyo RA, Cherkin DC, Kreuter W. Low back pain hospitalization. Recent United States trends and regional variations. Spine (Phila Pa 1976). 1994 Jun 1;19(11):1207-12; discussion 13. doi: 10.1097/00007632-199405310-00002.
PubMed 8073311Brown MD, Lockwood JM. Degenerative spondylolisthesis. Instr Course Lect. 1983;32:162-9.
PubMed 6546064Kostuik JP, Harrington I, Alexander D, Rand W, Evans D. Cauda equina syndrome and lumbar disc herniation. J Bone Joint Surg Am. 1986 Mar;68(3):386-91.
PubMed 2936744Magora A. Conservative treatment in spondylolisthesis. Clin Orthop Relat Res. 1976 Jun;(117):74-9.
PubMed 132329Matsunaga S, Ijiri K, Hayashi K. Nonsurgically managed patients with degenerative spondylolisthesis: a 10- to 18-year follow-up study. J Neurosurg. 2000 Oct;93(2 Suppl):194-8. doi: 10.3171/spi.2000.93.2.0194.
PubMed 11012048Herkowitz HN. Spine update. Degenerative lumbar spondylolisthesis. Spine (Phila Pa 1976). 1995 May 1;20(9):1084-90. doi: 10.1097/00007632-199505000-00018.
PubMed 7631240Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.
PubMed 18287602Atlas SJ, Keller RB, Robson D, Deyo RA, Singer DE. Surgical and nonsurgical management of lumbar spinal stenosis: four-year outcomes from the maine lumbar spine study. Spine (Phila Pa 1976). 2000 Mar 1;25(5):556-62. doi: 10.1097/00007632-200003010-00005.
PubMed 10749631Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.
PubMed 2071615Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine (Phila Pa 1976). 1999 Sep 1;24(17):1820-32. doi: 10.1097/00007632-199909010-00012.
PubMed 10488513Fischgrund JS, Mackay M, Herkowitz HN, Brower R, Montgomery DM, Kurz LT. 1997 Volvo Award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2807-12. doi: 10.1097/00007632-199712150-00003.
PubMed 9431616Kornblum MB, Fischgrund JS, Herkowitz HN, Abraham DA, Berkower DL, Ditkoff JS. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective long-term study comparing fusion and pseudarthrosis. Spine (Phila Pa 1976). 2004 Apr 1;29(7):726-33; discussion 733-4. doi: 10.1097/01.brs.0000119398.22620.92.
PubMed 15087793
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2 Surgical Approaches in the Treatment of Degenerative Spondylolysthesis: Posterolateral Fusion With Instrumentation (GPLI) Plus or Minus Transforaminal Lumbar Interbody Fusion (TLIF)
- ClinicalTrials.gov ID
- NCT00869882
- Acronym / sponsor ID
- SPONGIT / CHUBX 2008/33
- Conditions
- Degenerative Spondylolisthesis
- Keywords
- Spondylolisthesis, degeneration, spinal fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Mar 2009 (estimated)
- 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 trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion.
Detailed description
Degenerative spondylolisthesis is defined as the slip of one vertebra onto the other due to degenerative lesions; the L4-L5 intervertebral space is mainly involved. Mean age of symptomatic disease is about 60. Surgery is indicated in the presence of radiculalgia and/or neurological claudication and/or invalidating lombalgia, worsening neurological deficit, presence of sphincterian incontinence.
Surgical treatment of degenerative spondylolisthesis usually consists in neural decompression followed by posterolateral fusion with instrumentation. In the literature, fusion rate is estimated to be 80% with GPLI and seems to be increased by interbody fusion, especially transforaminal lumbar interbody fusion which has the advantage of unilateral disc interspace route, and fusion rate over 90%.
It seems that hypolordosis in the instrumented segments caused increased loading of the posterior column in the adjacent segments. These biomechanical effects may explain the degenerative changes at the junction level that have been observed as long-term consequences of lumbar fusion.
In addition to fusion, segmental lordosis gain seems to be an important long-term prognostic factor. Segmental lordosis recovery (upper than 3° in order to take into account measurement variability), was never assessed after TLIF procedure nor compared to that after posterolateral fusion in controlled randomized clinical trials.
The main objective of the study is the comparison of efficacy between circumferential fusion (TLIF plus GPLI) and GPLI alone as surgical treatment of degenerative spondylolisthesis in term of "Success" rate, defined as fusion and at least 3-degree increase of segmental lordosis angle, 24 months after surgery.
In this trial, included patients will be randomly assigned to undergo either posterolateral fusion with instrumentation (GPLI) or circumferential fusion with transforaminal lumbar interbody fusion (TLIF) combined to GPLI. In both arms, bone autograft will be performed using loose fragments obtained during neurological decompression.
Six visits are planned during the study: pre-inclusion visit within 3 months before surgery, inclusion/randomisation on the day before surgery, 3 follow-up visits (2, 6, and 12 months after surgery) and an end of study visit 24 months after surgery (or at time of withdrawal if relevant). Hospital stay (about one week, on average) is planned after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Circumferential arthrodesisPosterolateral fusion with instrumentation combined to transforaminal lumbar interbody fusion |
| 2 | Active comparator | Procedure: Posterolateral fusion with instrumentationPosterolateral fusion with instrumentation |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged less than 75,
- Having been informed about clinical trial objectives and risk,
- Covered by health insurance system,
- Suffering from degenerative spondylolisthesis (whatever the grade and intervertebral disc height) needing one-level surgical fusion due to either invalidating lombalgia/radiculalgia despite 6-month optimal medical treatment and/or motor neurological symptoms.
Key exclusion criteria (8 listed)
- Previous lumbar fusion,
- Previous spine traumatism,
- Presence of at least one major contraindication to surgery and/or general anaesthesia (ie, non controlled coagulopathy, active infection, or serious underlying disease, auto-immune affection).
- Presence of at least one contraindication to either TLIF or GPLI,
- Severe radiological osteoporosis.
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 |
|---|---|---|
| Circumferential arthrodesisAlso: TLIF+GPLIPatients are carefully positioned in the proned position and submitted to a posterior surgical approach under general anaesthesia. Surgical levels are viewed laterally by mean of intraoperative radiographs which can be performed at surgeon's demand during the whole surgery time. The preceding procedure is performed. In case of foraminal stenosis, decompression is performed at the same time as discal approach via the narrowest foramen. In addition to this, before preparation of bed for bone grafting, nerve roots are retracted and the disc nucleus is removed entirely, then endplate decortication is performed. The disc space is distracted. The most anterior part of the disc space is packed with cancellous bone. A cage packed with bone is inserted into the anterior portion of the interspace. According to cage location, bone graft could be inserted in the posterior portion of the interspace. Cage placement is radiologically checked. The end of the procedure is the same as for GPLI. | Procedure or surgery | 1 |
| Posterolateral fusion with instrumentationAlso: GPLIPatients are carefully positioned in pronation and submitted to a posterior surgical approach under general anaesthesia. Surgical levels are viewed laterally by mean of intraoperative radiographs performed at surgeon's demand during the whole surgery time. Pedicle screw instrumentation is performed, followed by posterior neural decompression depending on the type of stenosis: * Central stenosis: decompression is performed including medial facectomy, laminectomy; * Foraminal stenosis: foraminotomy is performed, while preserving a graft bed as large as possible; * Pure foraminal stenosis: spinal duct is not opened. Local bone is harvested from the lamina and the spinous process and carefully fragmented for autologous graft. Subperiosteal dissection is performed between the transverse processes and lateral aspects of the facet joints. Two rods are placed and locked on screws in maximum compression to optimize segmental lordosis. Bone autograft is placed into this bed. | Procedure or surgery | 2 |
Primary outcome
Success rate defined as fusion associated to at least a 3-degree increase of segmental lordosis angle and the absence of a reintervention due to a failure of the initial intervention
Time frame: 24 months after surgery
7 secondary outcomes
Major complication (ie, life threatening haemorrhage, severe and persisting neurological worsening, deep infection) rate, and minor complication rate
Time frame: within 24 months after surgery
Success rate defined as both fusion and at least 3-degree increase of segmental lordosis angle
Time frame: 6 and 12 months after surgery
Lumbar and radicular pain outcome
Time frame: 2, 6, 12 and 24 months after surgery
Functional outcome: Oswestry Disability Index and modified Prolo Economic and Functional scores
Time frame: 2, 6, 12 and 24 months after surgery
Change of pelvic and radiological parameters (ie, lumbar lordosis angle, medial intervertebral space height
Time frame: 2, 6, 12 and 24 months after surgery
Quality of life outcome: SF-36
Time frame: 2, 6, 12 and 24 months after surgery
Per and post operative surgery parameters (ie, operative time, blood loss, hospitalization stay duration)
Time frame: within hospital stay due to 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 14 May 2026.
- Background: PubMed 1141255Rosenberg NJ. Degenerative spondylolisthesis. Predisposing factors. J Bone Joint Surg Am. 1975 Jun;57(4):467-74.
- Background: PubMed 10708989Frymoyer JW. Degenerative Spondylolisthesis: Diagnosis and Treatment. J Am Acad Orthop Surg. 1994 Jan;2(1):9-15. doi: 10.5435/00124635-199401000-00002.
- Background: PubMed 16582855Cummins J, Lurie JD, Tosteson TD, Hanscom B, Abdu WA, Birkmeyer NJ, Herkowitz H, Weinstein J. Descriptive epidemiology and prior healthcare utilization of patients in the Spine Patient Outcomes Research Trial's (SPORT) three observational cohorts: disc herniation, spinal stenosis, and degenerative spondylolisthesis. Spine (Phila Pa 1976). 2006 Apr 1;31(7):806-14. doi: 10.1097/01.brs.0000207473.09030.0d.
- Background: PubMed 8073311Taylor VM, Deyo RA, Cherkin DC, Kreuter W. Low back pain hospitalization. Recent United States trends and regional variations. Spine (Phila Pa 1976). 1994 Jun 1;19(11):1207-12; discussion 13. doi: 10.1097/00007632-199405310-00002.
- Background: PubMed 6546064Brown MD, Lockwood JM. Degenerative spondylolisthesis. Instr Course Lect. 1983;32:162-9.
- Background: PubMed 2936744Kostuik JP, Harrington I, Alexander D, Rand W, Evans D. Cauda equina syndrome and lumbar disc herniation. J Bone Joint Surg Am. 1986 Mar;68(3):386-91.
- Background: PubMed 132329Magora A. Conservative treatment in spondylolisthesis. Clin Orthop Relat Res. 1976 Jun;(117):74-9.
- Background: PubMed 11012048Matsunaga S, Ijiri K, Hayashi K. Nonsurgically managed patients with degenerative spondylolisthesis: a 10- to 18-year follow-up study. J Neurosurg. 2000 Oct;93(2 Suppl):194-8. doi: 10.3171/spi.2000.93.2.0194.
- Background: PubMed 7631240Herkowitz HN. Spine update. Degenerative lumbar spondylolisthesis. Spine (Phila Pa 1976). 1995 May 1;20(9):1084-90. doi: 10.1097/00007632-199505000-00018.
- Background: PubMed 18287602Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.
- Background: PubMed 10749631Atlas SJ, Keller RB, Robson D, Deyo RA, Singer DE. Surgical and nonsurgical management of lumbar spinal stenosis: four-year outcomes from the maine lumbar spine study. Spine (Phila Pa 1976). 2000 Mar 1;25(5):556-62. doi: 10.1097/00007632-200003010-00005.
- Background: PubMed 2071615Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.
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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.
Patrick GUERIN, MD principal investigator
University Hospital Bordeaux, France
Antoine BENARD, MD study chair
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circumferential arthrodesis and Posterolateral fusion with instrumentation in people with Degenerative Spondylolisthesis, run by University Hospital, Bordeaux 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 8 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 14 May 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?
Success rate defined as fusion associated to at least a 3-degree increase of segmental lordosis angle and the absence of a reintervention due to a failure of the initial intervention (time frame: 24 months 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 NCT00869882, which also lists 39 linked publications.
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 14 May 2026.