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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorJos M. A. Kuijlen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-75 years

Degenerative or spondylolytic spondylolisthesis

Neurogenic claudication and/or radicular leg pain

Low grade (Meyerding grade l and ll)

Disqualifiers

Previous spine fusion surgery at the same level

Osteoporosis

Active infection or prior infection at the surgical site

Active cancer

Trial 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).

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Posterior Lumbar Interbody Fusion (PLIF)

    Procedure/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.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Open PLIF1 intervention
Group B: CBT-PLIF1 intervention
Group C: MI-PLIF1 intervention

Trial outcomes

Primary outcomes

1

VAS low back pain

VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)

Time frame
2 weeks postoperative

Secondary outcomes

1

VAS low back pain

VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)

Time frame
During hospital stay, measured each day and 6 weeks postoperative
2

VAS leg pain

VAS for leg pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)

Time frame
During hospital stay, measured each day, 2 and 6 weeks postoperative
3

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)

Time frame
2 and 6 weeks postoperative
4

Quality of Life (QoL)

Measured by the EQ-5D-5L

Time frame
2 and 6 weeks postoperative

Other outcomes

Sponsors and contacts

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Jos M. A. Kuijlen

Lead sponsor

University Medical Center Groningen

Sponsor institution