Degenerative SpondylolisthesisNCT05538416
Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion
An observational study of Degenerative Spondylolisthesis and Spondylolytic Spondylolisthesis, run by Jos M. A. Kuijlen at 1 site in Netherlands.
Trial summary
A combined prospective cohort study and retrospective analysis of previously collected data. Three different techniques for posterior lumbar interbody fusion (PLIF) are compared: CBT-PLIF, MI-PLIF and open PLIF. A total of 180 patients are included, who will be followed up to 6 weeks postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Spondylolisthesis, Spondylolytic Spondylolisthesis
- What is being tested?
- Posterior Lumbar Interbody Fusion (PLIF)
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Sep 2022to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 180 participants, 60 prospective CBT-PLIF participants, 60 retrospective open-PLIF and 60 retrospective MI-PLIF participants. Patients aged 18-75 years with neurogenic claudication and/or radicular leg pain due to a low grade (Meyerding grade l and ll) degenerative or spondylolytic spondylolisthesis with persistent complaints for over 3 months will be included in the study. Patients are operated in either the University Medical Centre Groningen (UMCG) or in the Haaglanden Medical Centre (HMC).
Who may be able to join
- 18-75 years
- Degenerative or spondylolytic spondylolisthesis
- Neurogenic claudication and/or radicular leg pain
- Low grade (Meyerding grade l and ll)
- Persistent complaints for over 3 months
Who cannot join
- Previous spine fusion surgery at the same level
- Osteoporosis
- Active infection or prior infection at the surgical site
- Active cancer
- Spondylolisthesis grade lll or greater
- More than one symptomatic level that needs fusion
Show all 12Show fewer
- Pregnancy
- Contraindication for surgery
- Severe mental or psychiatric disorder
- Substance abuse
- Inadequate knowledge of Dutch language
- Morbid obesity (body mass index >40)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMCG
Groningen, 9713 GZ
Jos MA Kuijlen, MD/PHD, 050 361 2837, jmakuijlen@umcg.nl
About this study
A combined prospective cohort study and retrospective analysis of previously collected data. Three different techniques for posterior lumbar interbody fusion (PLIF) are compared: CBT-PLIF, MI-PLIF and open PLIF. A total of 180 patients are included, who will be followed up to 6 weeks postoperatively.
Read the detailed description
A combined prospective cohort study for CBT-PLIF and retrospective analysis of prospectively collected data from the MISOS study, regarding traditional open PLIF and MI-PLIF. A total of 180 patients will be included in the study: 60 prospective CBT-PLIF patients, 60 retrospective open PLIF patients and 60 retrospective MI-PLIF patients.
The new data will be collected prospectively by means of questionnaires. No biomaterial will be collected. The included patients will be asked to complete questionnaires before surgery, 2 and 6 weeks after surgery. In addition, VAS scores will be noted throughout the hospital stay, 2 and 6 weeks after surgery.
Inclusion criteria: Patients aged 18-75 years with neurogenic claudication and/or radicular leg pain due to low-grade (Meyerding grades l and ll) degenerative or spondylolytic spondylolisthesis with persistent symptoms for more than 3 months.
Exclusion criteria: previous spinal fusion surgery at the same level, osteoporosis (only when using bisphosphonate), active infection or previous infection at the surgical site, active cancer, spondylolisthesis grade III or greater, more than one symptomatic level requiring fusion, pregnancy, contraindication to surgery, severe mental or psychiatric disorder, substance abuse, insufficient knowledge of the Dutch language and morbid obesity (body mass index >40).
Main research question: Does the CBT-PLIF provide less low back pain in the short term than the traditional open PLIF and the MI-PLIF?
Primary outcome measure
- Low back pain measured with the Visual Analogue Scale (VAS) 2 weeks after surgery Secondary Outcomes
- Low back pain during hospitalization (measured every day), 2 and 6 weeks after surgery
- Leg pain
- Oswestry Disability Index
- Quality of life (EQ-5D-5L)
- Observed patient recovery
- Other parameters such as complications, surgical parameters (intraoperative blood loss, duration of surgery), length of stay in hospital and return to work
- Being tested
- Posterior Lumbar Interbody Fusion (PLIF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Lumbar Interbody Fusion (PLIF)Procedure or surgery
Spinal fusion in the lumbar spine by inserting a cage directly into the disc space. This is an observational study in which the standard procedure/care is followed.
| Study group | Role | What they receive |
|---|---|---|
| Open PLIF | Patients undergoing conventional open posterior lumbar interbody fusion (PLIF) surgery. A long midline skin incision (10-15 cm) is made, after which the paravertebral muscles are detached from the midline and retracted laterally in order to expose the facet joints and pedicle entry point. After the pedicle screws are positioned, the disc will be removed bilaterally and packed with autogenous bone chips, followed by bilateral placement of polyetheretherketone (PEEK) PLIF cages. Receives: Procedure: Posterior Lumbar Interbody Fusion (PLIF) | |
| CBT-PLIF | Patient undergoing minimal access PLIF surgery with cortical bone trajectory (CBT-PLIF). The CBT-PLIF uses more medialized entry points, closer to the spinal process. Due to the medial approach of this technique, a smaller incision is needed and the need to retract muscles laterally is minimalized. Receives: Procedure: Posterior Lumbar Interbody Fusion (PLIF) | |
| MI-PLIF | Patients undergoing minimal invasive PLIF surgery. A small midline incision (3-5 cm) will be made to perform mini-open decompression and placement of bilateral PEEK PLIF cages. In addition, two small paramedian incisions will be made on both sides for percutaneous pedicle screw fixation. Receives: Procedure: Posterior Lumbar Interbody Fusion (PLIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS low back pain
VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)
Measured: 2 weeks postoperative
Secondary outcomes (5)
VAS low back pain
VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)
Measured: During hospital stay, measured each day and 6 weeks postoperative
VAS leg pain
VAS for leg pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)
Measured: During hospital stay, measured each day, 2 and 6 weeks postoperative
Oswestry Disability Index
Used to quantify the degree of functional impairment in patients with low back pain. Ranging from 0 (no disability) to 100 (bed bound)
Measured: 2 and 6 weeks postoperative
Quality of Life (QoL)
Measured by the EQ-5D-5L
Measured: 2 and 6 weeks postoperative
Perceived recovery of the patient
scored on a 7-Likert scale, with scores ranging from 'worse than ever' to 'complete recovery'
Measured: 2 and 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start19 Sep 2022
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative 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
- Other
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jos M. A. Kuijlen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jos M. A. Kuijlen, University Medical Center Groningen
- Investigators
- Jos M.A. Kuijlen, MD, PhD, Principal investigator, University Medical Centre Groningen (UMCG), Hanzeplein 1, 9713GZ Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538416
- Sponsor's protocol ID
- UMCG202200129
- Status last verified
- May 2025
- First submitted
- 9 Sep 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT05538416
- Acronym / sponsor ID
- UMCG202200129
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Jos M. A. KuijlenUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Sep 2022 (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.
A combined prospective cohort study and retrospective analysis of previously collected data. Three different techniques for posterior lumbar interbody fusion (PLIF) are compared: CBT-PLIF, MI-PLIF and open PLIF. A total of 180 patients are included, who will be followed up to 6 weeks postoperatively.
Detailed description
A combined prospective cohort study for CBT-PLIF and retrospective analysis of prospectively collected data from the MISOS study, regarding traditional open PLIF and MI-PLIF. A total of 180 patients will be included in the study: 60 prospective CBT-PLIF patients, 60 retrospective open PLIF patients and 60 retrospective MI-PLIF patients.
The new data will be collected prospectively by means of questionnaires. No biomaterial will be collected. The included patients will be asked to complete questionnaires before surgery, 2 and 6 weeks after surgery. In addition, VAS scores will be noted throughout the hospital stay, 2 and 6 weeks after surgery.
Inclusion criteria: Patients aged 18-75 years with neurogenic claudication and/or radicular leg pain due to low-grade (Meyerding grades l and ll) degenerative or spondylolytic spondylolisthesis with persistent symptoms for more than 3 months.
Exclusion criteria: previous spinal fusion surgery at the same level, osteoporosis (only when using bisphosphonate), active infection or previous infection at the surgical site, active cancer, spondylolisthesis grade III or greater, more than one symptomatic level requiring fusion, pregnancy, contraindication to surgery, severe mental or psychiatric disorder, substance abuse, insufficient knowledge of the Dutch language and morbid obesity (body mass index >40).
Main research question: Does the CBT-PLIF provide less low back pain in the short term than the traditional open PLIF and the MI-PLIF?
Primary outcome measure
- Low back pain measured with the Visual Analogue Scale (VAS) 2 weeks after surgery Secondary Outcomes
- Low back pain during hospitalization (measured every day), 2 and 6 weeks after surgery
- Leg pain
- Oswestry Disability Index
- Quality of life (EQ-5D-5L)
- Observed patient recovery
- Other parameters such as complications, surgical parameters (intraoperative blood loss, duration of surgery), length of stay in hospital and return to work
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open PLIF | – | Procedure: Posterior Lumbar Interbody Fusion (PLIF)Patients undergoing conventional open posterior lumbar interbody fusion (PLIF) surgery. A long midline skin incision (10-15 cm) is made, after which the paravertebral muscles are detached from the midline and retracted laterally in order to expose the facet joints and pedicle entry point. After the pedicle screws are positioned, the disc will be removed bilaterally and packed with autogenous bone chips, followed by bilateral placement of polyetheretherketone (PEEK) PLIF cages. |
| CBT-PLIF | – | Procedure: Posterior Lumbar Interbody Fusion (PLIF)Patient undergoing minimal access PLIF surgery with cortical bone trajectory (CBT-PLIF). The CBT-PLIF uses more medialized entry points, closer to the spinal process. Due to the medial approach of this technique, a smaller incision is needed and the need to retract muscles laterally is minimalized. |
| MI-PLIF | – | Procedure: Posterior Lumbar Interbody Fusion (PLIF)Patients undergoing minimal invasive PLIF surgery. A small midline incision (3-5 cm) will be made to perform mini-open decompression and placement of bilateral PEEK PLIF cages. In addition, two small paramedian incisions will be made on both sides for percutaneous pedicle screw fixation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 180 participants, 60 prospective CBT-PLIF participants, 60 retrospective open-PLIF and 60 retrospective MI-PLIF participants. Patients aged 18-75 years with neurogenic claudication and/or radicular leg pain due to a low grade (Meyerding grade l and ll) degenerative or spondylolytic spondylolisthesis with persistent complaints for over 3 months will be included in the study. Patients are operated in either the University Medical Centre Groningen (UMCG) or in the Haaglanden Medical Centre (HMC).
Key inclusion criteria (5 listed)
- 18-75 years
- Degenerative or spondylolytic spondylolisthesis
- Neurogenic claudication and/or radicular leg pain
- Low grade (Meyerding grade l and ll)
- Persistent complaints for over 3 months
Key exclusion criteria (12 listed)
- Previous spine fusion surgery at the same level
- Osteoporosis
- Active infection or prior infection at the surgical site
- Active cancer
- Spondylolisthesis grade lll or greater
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 |
|---|---|---|
| Posterior Lumbar Interbody Fusion (PLIF)Spinal fusion in the lumbar spine by inserting a cage directly into the disc space. This is an observational study in which the standard procedure/care is followed. | Procedure or surgery | CBT-PLIF, MI-PLIF, Open PLIF |
Primary outcome
VAS low back pain
Time frame: 2 weeks postoperative
VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)
5 secondary outcomes
VAS low back pain
Time frame: During hospital stay, measured each day and 6 weeks postoperative
VAS leg pain
Time frame: During hospital stay, measured each day, 2 and 6 weeks postoperative
Oswestry Disability Index
Time frame: 2 and 6 weeks postoperative
Quality of Life (QoL)
Time frame: 2 and 6 weeks postoperative
Perceived recovery of the patient
Time frame: 2 and 6 weeks postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- 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.
Jos M.A. Kuijlen, MD, PhD principal investigator
University Medical Centre Groningen (UMCG), Hanzeplein 1, 9713GZ Groningen
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 Degenerative Spondylolisthesis and Spondylolytic Spondylolisthesis, run by Jos M. A. Kuijlen at 1 site in Netherlands.
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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane H. Steenks (050 3617976, d.h.steenks@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS low back pain (time frame: 2 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2025.