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

• ClinicalTrials.gov Identifier: NCT04589572
• Recruitment Status: Suspended
• First Posted: October 19, 2020
• Last Update Posted: January 12, 2021
• Sponsor: Hasselt University
• Collaborators: Jessa Hospital; Sint-Trudo Hospital; Sint-Franciscus Ziekenhuis
• Information provided by (Responsible Party): Frank Vandenabeele, Hasselt University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Muscle Damage; Atrophy; Degenerative Diseases, Spinal Cord	Procedure: XLIF; Procedure: PLIF	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: EXTREME LATERAL INTERBODY FUSION (XLIF) VERSUS POSTERIOR LUMBAR INTERBODY FUSION (PLIF)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Structural and Funcional Outcomes of Extreme Lateral Interbody Fusion (XLIF) Compared to Posterior Lumbar Interbody Fusion (PLIF)
• Actual Study Start Date: January 1, 2020
• Estimated Primary Completion Date: October 1, 2021
• Estimated Study Completion Date: January 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: XLIF - group	Procedure: XLIF; 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.
Active Comparator: PLIF - Group	Procedure: PLIF; open posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) are used to treat degenerative diseases of the spinal column.

Outcome Measures

Primary Outcome Measures :

1. Paraspinal muscle biopsy [ Time Frame: - 1 week ]
   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.
2. 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.
3. concentration of C-Reactive Protein [ Time Frame: - 1 week ]
   Blood analysis
4. concentration of C-Reactive Protein [ Time Frame: 24 hours after surgery ]
   Blood analysis
5. concentration of C-Reactive Protein [ Time Frame: 48 hours after surgery ]
   Blood analysis
6. concentration of C-Reactive Protein [ Time Frame: week 8 ]
   Blood analysis
7. concentration of Calcium [ Time Frame: - 1 week ]
   Blood analysis
8. concentration of Calcium [ Time Frame: 24 hours after surgery ]
   Blood analysis
9. concentration of Calcium [ Time Frame: 48 hours after surgery ]
   Blood analysis
10. concentration of Calcium [ Time Frame: week 8 ]
    Blood analysis
11. concentration of Phosphate [ Time Frame: - 1 week ]
    Blood analysis
12. concentration of Phosphate [ Time Frame: 24 hours after surgery ]
    Blood analysis
13. concentration of Phosphate [ Time Frame: 48 hours after surgery ]
    Blood analysis
14. concentration of Phosphate [ Time Frame: week 8 ]
    Blood analysis
15. concentration of Creatine kinase [ Time Frame: - 1 week ]
    Blood analysis
16. concentration of Creatine kinase [ Time Frame: 24 hours after surgery ]
    Blood analysis
17. concentration of Creatine kinase [ Time Frame: 48 hours after surgery ]
    Blood analysis
18. concentration of Creatine kinase [ Time Frame: week 8 ]
    Blood analysis
19. concentration of Myoglobine [ Time Frame: - 1 week ]
    Blood analysis
20. concentration of Myoglobine [ Time Frame: 24 hours after surgery ]
    Blood analysis
21. concentration of Myoglobine [ Time Frame: 48 hours after surgery ]
    Blood analysis
22. concentration of Myoglobine [ Time Frame: week 8 ]
    Blood analysis
23. concentration of Lactate dehydrogenase [ Time Frame: - 1 week ]
    Blood analysis
24. concentration of Lactate dehydrogenase [ Time Frame: 24 hours after surgery ]
    Blood analysis
25. concentration of Lactate dehydrogenase [ Time Frame: 48 hours after surgery ]
    Blood analysis
26. concentration of Lactate dehydrogenase [ Time Frame: week 8 ]
    Blood analysis
27. concentration of Alkaline phosphatase [ Time Frame: - 1 week ]
    Blood analysis
28. concentration of Alkaline phosphatase [ Time Frame: 24 hours after surgery ]
    Blood analysis
29. concentration of Alkaline phosphatase [ Time Frame: 48 hours after surgery ]
    Blood analysis
30. concentration of Alkaline phosphatase [ Time Frame: week 8 ]
    Blood analysis

Secondary Outcome Measures :

1. Magnetic Resonance Imaging (MRI) [ Time Frame: - 1 week ]
   MRI images will be used to evaluate paraspinal and iliopsoas muscle cross-sectional area (CSA), and functional cross-sectional area (FCSA).
2. Magnetic Resonance Imaging (MRI) [ Time Frame: week 8 ]
   MRI images will be used to evaluate paraspinal and iliopsoas muscle cross-sectional area (CSA), and functional cross-sectional area (FCSA).
3. DEXA-san (Dual-energy X-ray Absorptiometry). [ Time Frame: - 1 week ]
   Participants will undergo a DEXA-scan to evaluate body composition
4. DEXA-san (Dual-energy X-ray Absorptiometry). [ Time Frame: week 8 ]
   Participants will undergo a DEXA-scan to evaluate body composition
5. activity tracker [ Time Frame: From - 1 week up to week 8 (24 hours a day) ]
   Participant will were an activity tracker from -1 week -1 until week 8 to compare activity patterns between groups
6. Visual analogue scale (VAS) [ Time Frame: - 1 week ]
   The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
7. Visual analogue scale (VAS) [ Time Frame: 24 hours after surgery ]
   The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
8. Visual analogue scale (VAS) [ Time Frame: 48 hours after surgery ]
   The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
9. Visual analogue scale (VAS) [ Time Frame: week 8 ]
   The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
10. Pain catastrophizing scale (PCS) [ Time Frame: - 1 Week ]
    Participants are asked to indicate the degree to which they have specific thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale.
11. Pain catastrophizing scale (PCS) [ Time Frame: week 8 ]
    Participants are asked to indicate the degree to which they have specific thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale.
12. Pain vigilance and awareness questionnaire (PVAQ) [ Time Frame: - 1 week ]
    The PVAQ is a 16-item measure of attention to pain that assesses awareness, consciousness, vigilance, and observation of pain.
13. Pain vigilance and awareness questionnaire (PVAQ) [ Time Frame: week 8 ]
    The PVAQ is a 16-item measure of attention to pain that assesses awareness, consciousness, vigilance, and observation of pain.
14. Oswestry Disability Index (ODI) [ Time Frame: - 1 week ]
    This is a questionnaire than has been proven valid and reliable to evaluate the restrictions that people with low back pain experience during their daily living. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
15. Oswestry Disability Index (ODI) [ Time Frame: week 8 ]
    This is a questionnaire than has been proven valid and reliable to evaluate the restrictions that people with low back pain experience during their daily living. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
16. EQ5D questionaire [ Time Frame: - 1 week ]
    The EQ-5D is a standardized questionnaire in which five levels of health (mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression ) can be scored. The patients also has to indicate how he/she experiences their health state on a scale from 0 to 100.
17. EQ5D questionaire [ Time Frame: week 8 ]
    The EQ-5D is a standardized questionnaire in which five levels of health (mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression ) can be scored. The patients also has to indicate how he/she experiences their health state on a scale from 0 to 100.
18. Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) [ Time Frame: - 1 week ]
    The PASIPD is a reliable and valid questionnaire consisting of 13 items to measure the physical activity of people with disabilities. The average hours per day for each item is scored, and is multiplied by a metabolic equivalent (MET) value associated with the intensity of the activity and summing over items 2 through 13. Scores range from 0 (no activity) to >100 METS hour/day (very high).
19. Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) [ Time Frame: week 8 ]
    The PASIPD is a reliable and valid questionnaire consisting of 13 items to measure the physical activity of people with disabilities. The average hours per day for each item is scored, and is multiplied by a metabolic equivalent (MET) value associated with the intensity of the activity and summing over items 2 through 13. Scores range from 0 (no activity) to >100 METS hour/day (very high).
20. The Tampa Scale for Kinesiophobia (TSK) [ Time Frame: - 1 week ]
    : The TSK is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. The higher the score the more fear of movement will be present, with a maximum score of 68. The cut of value to state a patient is experiencing fear of movement is 37/68.
21. The Tampa Scale for Kinesiophobia (TSK) [ Time Frame: week 8 ]
    : The TSK is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. The higher the score the more fear of movement will be present, with a maximum score of 68. The cut of value to state a patient is experiencing fear of movement is 37/68.
22. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [ Time Frame: - 1 week ]
    The PS is a simple measure of functional status, originally developed by the ECOG to evaluate cancer treatment toxicity. It has scores from 0-5 that correlate with the Karnofsky scale. Although this instrument has been developed to evaluate cancer treatment, it has been used to evaluate the post-operative performance status in persons undergoing lumbar surgery
23. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [ Time Frame: 24 hours after surgery ]
    The PS is a simple measure of functional status, originally developed by the ECOG to evaluate cancer treatment toxicity. It has scores from 0-5 that correlate with the Karnofsky scale. Although this instrument has been developed to evaluate cancer treatment, it has been used to evaluate the post-operative performance status in persons undergoing lumbar surgery
24. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [ Time Frame: 48 hours after surgery ]
    The PS is a simple measure of functional status, originally developed by the ECOG to evaluate cancer treatment toxicity. It has scores from 0-5 that correlate with the Karnofsky scale. Although this instrument has been developed to evaluate cancer treatment, it has been used to evaluate the post-operative performance status in persons undergoing lumbar surgery
25. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [ Time Frame: week 8 ]
    The PS is a simple measure of functional status, originally developed by the ECOG to evaluate cancer treatment toxicity. It has scores from 0-5 that correlate with the Karnofsky scale. Although this instrument has been developed to evaluate cancer treatment, it has been used to evaluate the post-operative performance status in persons undergoing lumbar surgery
26. Dietary intake [ Time Frame: up to week 8 ]
    Participant will be asked to register their food intake using a standardized form. This will be done on two week days, and one day during the weekend. This outcome will be used to asses a difference in protein intake, that might affect muscle atrophy after surgery (control parameter).
27. Blood loss [ Time Frame: week o ]
    Surgical blood loss needs to be reported in milliliters.
28. Operating time [ Time Frame: week o ]
    Time from the incision until closing of the operating site will be reported.
29. Complications [ Time Frame: week o ]
    Bleeding, infection, nerve damage, re-intervention, permanent injuries will be reported

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

Belgium

Jessa Ziekenhuis

Hasselt, Belgium, 3500

Sint-Franciscus Ziekenhuis

Heusden-Zolder, Belgium, 3550

Sint-Trudo Ziekenhuis

Sint-Truiden, Belgium, 3800

Sponsors and Collaborators

Hasselt University

Jessa Hospital

Sint-Trudo Hospital

Sint-Franciscus Ziekenhuis

Investigators

• Principal Investigator: Frank Vandenabeele, prof. dr.; Hasselt University
• Study Chair: Sjoerd stevens, drs.; Hasselt University

More Information

• Responsible Party: Frank Vandenabeele, Principal Investigator, Hasselt University
• ClinicalTrials.gov Identifier: NCT04589572
• Other Study ID Numbers: UH-XLIF-001
• First Posted: October 19, 2020
• Last Update Posted: January 12, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Spinal Diseases; Neurodegenerative Diseases; Atrophy; Pathological Conditions, Anatomical; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases