Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional Open and Minimal Invasive Posterior Lumbar Interbody Fusion
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Netherlands
UMCG
RECRUITING
Groningen
Contact Information
Primary
Diane H. Steenks
d.h.steenks@umcg.nl
050 3617976
Backup
Hui Ling Li, BsC
h.l.li@umcg.nl
0629249620
Time Frame
Start Date: 2022-09-19
Estimated Completion Date: 2025-12
Participants
Target number of participants: 180
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Jos M. A. Kuijlen