Extreme Lateral Interbody FusionFUSION (XLIF) Versus Posterior Lumbar Interbody Fusion (PLIF)

NCT04589572 | Suspended

• 1 other identifier: UH-XLIF-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Muscle Damage; Atrophy; Degenerative Diseases, Spinal Cord

Outcome Measures

Primary Outcomes (30)

• Paraspinal muscle biopsy

  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.

  - 1 week

• Paraspinal muscle biopsy

  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.

  week 8

• concentration of C-Reactive Protein

  Blood analysis

  - 1 week

• concentration of C-Reactive Protein

  Blood analysis

  24 hours after surgery

• concentration of C-Reactive Protein

  Blood analysis

  48 hours after surgery

• concentration of C-Reactive Protein

  Blood analysis

  week 8

• concentration of Calcium

  Blood analysis

  - 1 week

• concentration of Calcium

  Blood analysis

  24 hours after surgery

• concentration of Calcium

  Blood analysis

  48 hours after surgery

• concentration of Calcium

  Blood analysis

  week 8

• concentration of Phosphate

  Blood analysis

  - 1 week

• concentration of Phosphate

  Blood analysis

  24 hours after surgery

• concentration of Phosphate

  Blood analysis

  48 hours after surgery

• concentration of Phosphate

  Blood analysis

  week 8

• concentration of Creatine kinase

  Blood analysis

  - 1 week

• concentration of Creatine kinase

  Blood analysis

  24 hours after surgery

• concentration of Creatine kinase

  Blood analysis

  48 hours after surgery

• concentration of Creatine kinase

  Blood analysis

  week 8

• concentration of Myoglobine

  Blood analysis

  - 1 week

• concentration of Myoglobine

  Blood analysis

  24 hours after surgery

• concentration of Myoglobine

  Blood analysis

  48 hours after surgery

• concentration of Myoglobine

  Blood analysis

  week 8

• concentration of Lactate dehydrogenase

  Blood analysis

  - 1 week

• concentration of Lactate dehydrogenase

  Blood analysis

  24 hours after surgery

• concentration of Lactate dehydrogenase

  Blood analysis

  48 hours after surgery

• concentration of Lactate dehydrogenase

  Blood analysis

  week 8

• concentration of Alkaline phosphatase

  Blood analysis

  - 1 week

• concentration of Alkaline phosphatase

  Blood analysis

  24 hours after surgery

• concentration of Alkaline phosphatase

  Blood analysis

  48 hours after surgery

• concentration of Alkaline phosphatase

  Blood analysis

  week 8

Secondary Outcomes (29)

• Magnetic Resonance Imaging (MRI)

  - 1 week

• Magnetic Resonance Imaging (MRI)

  week 8

• DEXA-san (Dual-energy X-ray Absorptiometry).

  - 1 week

• DEXA-san (Dual-energy X-ray Absorptiometry).

  week 8

• activity tracker

  From - 1 week up to week 8 (24 hours a day)

Study Arms (2)

XLIF - group

EXPERIMENTAL

Procedure: XLIF

PLIF - Group

ACTIVE COMPARATOR

Procedure: PLIF

Interventions

XLIF PROCEDURE

the XLIF procedure, 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.

XLIF - group

PLIF PROCEDURE

open posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) are used to treat degenerative diseases of the spinal column.

PLIF - Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator
• Sint-Trudo Hospital: collaborator
• Sint-Franciscus Ziekenhuis: collaborator

Study Sites (3)

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Sint-Franciscus Ziekenhuis

Heusden-Zolder, 3550, Belgium

Location

Sint-Trudo Ziekenhuis

Sint-Truiden, 3800, Belgium

Location

MeSH Terms

Conditions

Atrophy; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• Frank Vandenabeele, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Sjoerd stevens, drs.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: EXTREME LATERAL INTERBODY FUSION (XLIF) VERSUS POSTERIOR LUMBAR INTERBODY FUSION (PLIF)

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: October 19, 2020
• Study Start: January 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

BE (3)