Clinical trial NCT04589572: Extreme Lateral Interbody FusionFUSION (XLIF) Versus Posterior Lumbar Interbody Fusion (PLIF)
Official title: Structural and Funcional Outcomes of Extreme Lateral Interbody Fusion (XLIF) Compared to Posterior Lumbar Interbody Fusion (PLIF)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Muscle Damage
Atrophy
Degenerative Diseases, Spinal Cord
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: Sint-Trudo Hospital
name: Sint-Franciscus Ziekenhuis
First posted: 2020-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: EXTREME LATERAL INTERBODY FUSION (XLIF) VERSUS POSTERIOR LUMBAR INTERBODY FUSION (PLIF)
Primary purpose: TREATMENT

Brief summary: Since the first successful spinal fusion surgery using a modern stabilization technique in 1909, surgical fusion has become one of the most commonly performed procedures for degenerative disease of the lumbar spine. The incidence of lumbar spinal fusion for degenerative conditions has more than doubled from 2000 until 2009. Despite the high incidence of fusion surgery, the decision making in lumbar fusion surgery is complicated by a wide variety of indications (the greatest measured in any surgical procedure). This could indicate there might be an overuse of lumbar fusion. However, decompression alone, or non-operative care for degenerative conditions may risk progressive spinal instability, intractable pain, and neurological impairment. These complications in the absence of fusion surgery, clearly demonstrate the beneficial effects of adding spinal fusion surgery. Because of its beneficial effect and high usage, it is of greatest importance to reduce postoperative disability and pain, by diminishing surgical invasiveness.

Traditional open posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) are used to treat degenerative diseases of the spinal column. These techniques require an extensive dissection of the paraspinal musculature, which in term can lead to muscle denervation, loss of function, muscular atrophy, and spinal instability. It has also been known that paraspinal muscle damage induced during surgery is related to long term disability and pain. With this knowledge, minimally invasive spine surgery began to develop in the mid-twentieth century. Since then, new direct approaches to the lumbar spine, known as lumbar lateral interbody fusion (LLIF), direct lateral interbody fusion (DLIF), or extreme lateral interbody fusion (XLIF), have been introduced.

This study will focus on XLIF. Ozgur. 2006 first reported the XLIF procedure, as a minimally invasive procedure that approaches the spine from the lateral via the space between the 12th rib and the highest point of the iliac crest. This approach allows direct access to the intervertebral disc space without disruption of the peritoneal structures or posterior paraspinal musculature. Ohba. 2017 compared XLIF with percutaneous pedicle screws to traditional PLIF, and found that PLIF was associated with less intraoperative blood loss, postoperative white blood cell (WBC) counts, C-reactive protein (CRP) levels, and creatine kinases (CK) levels, indicating less muscle damage. Postoperative recovery of performance was significantly faster in the XLIF group. 1-year disability and pain scores were also significantly lower in the XLIF group. Despite these significant better results reported in the XLIF group, the systematic review of Barbagallo. 2015 concluded that there is insufficient evidence of the comparative effectiveness of lateral lumbar interbody fusion (XLIF) versus PLIF/ TLIF surgery. This indicates that the evidence for choosing between XLIF or a traditional approach is still scarce, and no recommendations can be made.

This study will focus on comparing XLIF to PLIF. The objective of this study is to compare clinical and structural outcome measures between the XLIF and PLIF groups, to confirm our hypothesis that the minimally invasiveness of the XLIF technique facilitates a significant faster post-operative recovery, and improves functional and structural outcomes.


Eligibility criteria: Inclusion Criteria:

* Clinical single level disc degeneration
* Age between 18 and 65 years old
* Understand Dutch (writing and speaking)
* Symptom duration ≤ 5 years

Exclusion Criteria:

* Involvement of the L5-S1 or L2-L3 segment
* Psychiatric pathology/ problems (e.g. substance abuse)
* Pregnancy
* Being non-suitable for surgery
* BMI ≥35
* Other diagnosed neurological or musculoskeletal diseases that might affect the spinal column
* Not being able to function independently (activities of daily living)

Primary outcomes:
measure: Paraspinal muscle biopsy
timeFrame: - 1 week
measure: Paraspinal muscle biopsy
timeFrame: week 8
measure: concentration of C-Reactive Protein
timeFrame: - 1 week
measure: concentration of C-Reactive Protein
timeFrame: 24 hours after surgery
measure: concentration of C-Reactive Protein
timeFrame: 48 hours after surgery
measure: concentration of C-Reactive Protein
timeFrame: week 8
measure: concentration of Calcium
timeFrame: - 1 week
measure: concentration of Calcium
timeFrame: 24 hours after surgery
measure: concentration of Calcium
timeFrame: 48 hours after surgery
measure: concentration of Calcium
timeFrame: week 8
measure: concentration of Phosphate
timeFrame: - 1 week
measure: concentration of Phosphate
timeFrame: 24 hours after surgery
measure: concentration of Phosphate
timeFrame: 48 hours after surgery
measure: concentration of Phosphate
timeFrame: week 8
measure: concentration of Creatine kinase
timeFrame: - 1 week
measure: concentration of Creatine kinase
timeFrame: 24 hours after surgery
measure: concentration of Creatine kinase
timeFrame: 48 hours after surgery
measure: concentration of Creatine kinase
timeFrame: week 8
measure: concentration of Myoglobine
timeFrame: - 1 week
measure: concentration of Myoglobine
timeFrame: 24 hours after surgery
measure: concentration of Myoglobine
timeFrame: 48 hours after surgery
measure: concentration of Myoglobine
timeFrame: week 8
measure: concentration of Lactate dehydrogenase
timeFrame: - 1 week
measure: concentration of Lactate dehydrogenase
timeFrame: 24 hours after surgery
measure: concentration of Lactate dehydrogenase
timeFrame: 48 hours after surgery
measure: concentration of Lactate dehydrogenase
timeFrame: week 8
measure: concentration of Alkaline phosphatase
timeFrame: - 1 week
measure: concentration of Alkaline phosphatase
timeFrame: 24 hours after surgery
measure: concentration of Alkaline phosphatase
timeFrame: 48 hours after surgery
measure: concentration of Alkaline phosphatase
timeFrame: week 8
Secondary outcomes:
measure: Magnetic Resonance Imaging (MRI)
timeFrame: - 1 week
measure: Magnetic Resonance Imaging (MRI)
timeFrame: week 8
measure: DEXA-san (Dual-energy X-ray Absorptiometry).
timeFrame: - 1 week
measure: DEXA-san (Dual-energy X-ray Absorptiometry).
timeFrame: week 8
measure: activity tracker
timeFrame: From - 1 week up to week 8 (24 hours a day)
measure: Visual analogue scale (VAS)
timeFrame: - 1 week
measure: Visual analogue scale (VAS)
timeFrame: 24 hours after surgery
measure: Visual analogue scale (VAS)
timeFrame: 48 hours after surgery
measure: Visual analogue scale (VAS)
timeFrame: week 8
measure: Pain catastrophizing scale (PCS)
timeFrame: - 1 Week
measure: Pain catastrophizing scale (PCS)
timeFrame: week 8
measure: Pain vigilance and awareness questionnaire (PVAQ)
timeFrame: - 1 week
measure: Pain vigilance and awareness questionnaire (PVAQ)
timeFrame: week 8
measure: Oswestry Disability Index (ODI)
timeFrame: - 1 week
measure: Oswestry Disability Index (ODI)
timeFrame: week 8
measure: EQ5D questionaire
timeFrame: - 1 week
measure: EQ5D questionaire
timeFrame: week 8
measure: Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)
timeFrame: - 1 week
measure: Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)
timeFrame: week 8
measure: The Tampa Scale for Kinesiophobia (TSK)
timeFrame: - 1 week
measure: The Tampa Scale for Kinesiophobia (TSK)
timeFrame: week 8
measure: The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
timeFrame: - 1 week
measure: The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
timeFrame: 24 hours after surgery
measure: The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
timeFrame: 48 hours after surgery
measure: The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
timeFrame: week 8
measure: Dietary intake
timeFrame: up to week 8
measure: Blood loss
timeFrame: week o
measure: Operating time
timeFrame: week o
measure: Complications
timeFrame: week o
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Heusden-Zolder
country: Belgium
facility: Sint-Franciscus Ziekenhuis
city: Sint-Truiden
country: Belgium
facility: Sint-Trudo Ziekenhuis
Study officials:
affiliation: Hasselt University
name: Frank Vandenabeele, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Sjoerd stevens, drs.
role: STUDY_CHAIR
References: