Clinical trial NCT05538416: Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion
Official title: Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degenerative Spondylolisthesis
Spondylolytic Spondylolisthesis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Pregnancy
* Contraindication for surgery
* Severe mental or psychiatric disorder
* Substance abuse
* Inadequate knowledge of Dutch language
* Morbid obesity (body mass index \>40)

Primary outcomes:
measure: VAS low back pain
timeFrame: 2 weeks postoperative
Secondary outcomes:
measure: VAS low back pain
timeFrame: During hospital stay, measured each day and 6 weeks postoperative
measure: VAS leg pain
timeFrame: During hospital stay, measured each day, 2 and 6 weeks postoperative
measure: Oswestry Disability Index
timeFrame: 2 and 6 weeks postoperative
measure: Quality of Life (QoL)
timeFrame: 2 and 6 weeks postoperative
measure: Perceived recovery of the patient
timeFrame: 2 and 6 weeks postoperative
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: University Medical Centre Groningen (UMCG), Hanzeplein 1, 9713GZ Groningen
name: Jos M.A. Kuijlen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: