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

Degenerative Spondylolisthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538416
• Other study ID #: UMCG202200129
• Status: Recruiting
• Start date: September 19, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: Diane H. Steenks
• Phone: 050 3617976
• Email: d.h.steenks[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Degenerative Spondylolisthesis
• Spondylolisthesis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Jos M. A. Kuijlen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS low back pain	VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)	2 weeks postoperative
Secondary	VAS low back pain	VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)	During hospital stay, measured each day and 6 weeks postoperative
Secondary	VAS leg pain	VAS for leg pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)	During hospital stay, measured each day, 2 and 6 weeks postoperative
Secondary	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)	2 and 6 weeks postoperative
Secondary	Quality of Life (QoL)	Measured by the EQ-5D-5L	2 and 6 weeks postoperative
Secondary	Perceived recovery of the patient	scored on a 7-Likert scale, with scores ranging from 'worse than ever' to 'complete recovery'	2 and 6 weeks postoperative