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

Jos M. A. Kuijlen

Status: Enrolling

Conditions: Degenerative Spondylolisthesis; Spondylolytic Spondylolisthesis

Treatments: Procedure: Posterior Lumbar Interbody Fusion (PLIF)

Study type: Observational

Funder types: Other

Identifiers

NCT05538416

UMCG202200129

Details and patient eligibility

About

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.

Full 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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

180 participants in 3 patient groups

Open PLIF

Description:

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.

Treatment:

Procedure: Posterior Lumbar Interbody Fusion (PLIF)

CBT-PLIF

Description:

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.

Treatment:

Procedure: Posterior Lumbar Interbody Fusion (PLIF)

MI-PLIF

Description:

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.

Treatment:

Procedure: Posterior Lumbar Interbody Fusion (PLIF)