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

NCT05538416 | Recruiting

• 1 other identifier: UMCG202200129
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Spondylolisthesis; Spondylolytic Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• VAS low back pain

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

  2 weeks postoperative

Secondary Outcomes (5)

• VAS low back pain

  During hospital stay, measured each day and 6 weeks postoperative

• VAS leg pain

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

• Oswestry Disability Index

  2 and 6 weeks postoperative

• Quality of Life (QoL)

  2 and 6 weeks postoperative

• Perceived recovery of the patient

  2 and 6 weeks postoperative

Study Arms (3)

Open PLIF

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.

Procedure: Posterior Lumbar Interbody Fusion (PLIF)

CBT-PLIF

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.

Procedure: Posterior Lumbar Interbody Fusion (PLIF)

MI-PLIF

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.

Procedure: Posterior Lumbar Interbody Fusion (PLIF)

Interventions

Posterior Lumbar Interbody Fusion (PLIF) PROCEDURE

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.

CBT-PLIF; MI-PLIF; Open PLIF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jos M. A. Kuijlen: lead

Study Sites (1)

UMCG

Groningen, 9713 GZ, Netherlands

RECRUITING

Study Officials

• Jos M.A. Kuijlen, MD, PhD

  University Medical Centre Groningen (UMCG), Hanzeplein 1, 9713GZ Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane H. Steenks

CONTACT

050 3617976; d.h.steenks@umcg.nl

Hui Ling Li, BsC

CONTACT

0629249620; h.l.li@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. MD, PhD

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 13, 2022
• Study Start: September 19, 2022
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)