Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion

Recruiting

• Conditions: Degenerative Spondylolisthesis; Spondylolytic Spondylolisthesis

• Registration Number: NCT05538416
• Lead Sponsor: Jos M. A. Kuijlen

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

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-13
• Study Start: 2022-09-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAS low back pain	2 weeks postoperative	VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index	2 and 6 weeks postoperative	Used to quantify the degree of functional impairment in patients with low back pain. Ranging from 0 (no disability) to 100 (bed bound)
VAS low back pain	During hospital stay, measured each day and 6 weeks postoperative	VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)
Perceived recovery of the patient	2 and 6 weeks postoperative	scored on a 7-Likert scale, with scores ranging from 'worse than ever' to 'complete recovery'
VAS leg pain	During hospital stay, measured each day, 2 and 6 weeks postoperative	VAS for leg pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)
Quality of Life (QoL)	2 and 6 weeks postoperative	Measured by the EQ-5D-5L

Trial Locations

Locations (1)

UMCG; 🇳🇱 Groningen, Netherlands