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Clinical Trials/NCT04589572
NCT04589572
Suspended
Not Applicable

Structural and Funcional Outcomes of Extreme Lateral Interbody Fusion (XLIF) Compared to Posterior Lumbar Interbody Fusion (PLIF)

Hasselt University3 sites in 1 country40 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Muscle Damage
Sponsor
Hasselt University
Enrollment
40
Locations
3
Primary Endpoint
Paraspinal muscle biopsy
Status
Suspended
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
November 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Frank Vandenabeele

Principal Investigator

Hasselt University

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
  • Other diagnosed neurological or musculoskeletal diseases that might affect the spinal column
  • Not being able to function independently (activities of daily living)

Outcomes

Primary Outcomes

Paraspinal muscle biopsy

Time Frame: week 8

From each participant a sample will be obtained from the lumbar multifidus and erector spinae muscle before (T0) and after lumbar surgery (T4). These samples will be obtained using a minimally invasive ultrasound guided percutaneous biopsy technique using a local anesthetic. The samples will be immediately frozen. After cutting these will be used for immunofluorescent staining for myosin heavy chain I, IIA, and IIX. These staining's will be analyzed to measure muscle fiber size and number. These data will be used to evaluate within and between group differences in atrophy or shift in muscle fiber typing.

concentration of C-Reactive Protein

Time Frame: week 8

Blood analysis

concentration of Phosphate

Time Frame: week 8

Blood analysis

concentration of Creatine kinase

Time Frame: week 8

Blood analysis

concentration of Myoglobine

Time Frame: week 8

Blood analysis

concentration of Lactate dehydrogenase

Time Frame: week 8

Blood analysis

concentration of Calcium

Time Frame: week 8

Blood analysis

concentration of Alkaline phosphatase

Time Frame: week 8

Blood analysis

Secondary Outcomes

  • Pain catastrophizing scale (PCS)(week 8)
  • Blood loss(week o)
  • Visual analogue scale (VAS)(week 8)
  • Pain vigilance and awareness questionnaire (PVAQ)(week 8)
  • Oswestry Disability Index (ODI)(week 8)
  • Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)(week 8)
  • Magnetic Resonance Imaging (MRI)(week 8)
  • DEXA-san (Dual-energy X-ray Absorptiometry).(week 8)
  • activity tracker(From - 1 week up to week 8 (24 hours a day))
  • The Tampa Scale for Kinesiophobia (TSK)(week 8)
  • EQ5D questionaire(week 8)
  • The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)(week 8)
  • Dietary intake(up to week 8)
  • Operating time(week o)
  • Complications(week o)

Study Sites (3)

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