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

Muscle Damage Clinical Trial

— XLIF  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04589572
• Other study ID #: UH-XLIF-001
• Status: Suspended
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: May 2022
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrophy
• Degenerative Diseases, Spinal Cord
• Muscle Damage
• Neurodegenerative Diseases
• Spinal Diseases

Intervention

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

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Sint-Franciscus Ziekenhuis	Heusden-Zolder
Belgium	Sint-Trudo Ziekenhuis	Sint-Truiden

Sponsors (4)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital, Sint-Franciscus Ziekenhuis, Sint-Trudo Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	concentration of C-Reactive Protein	Blood analysis	- 1 week
Primary	concentration of C-Reactive Protein	Blood analysis	24 hours after surgery
Primary	concentration of C-Reactive Protein	Blood analysis	48 hours after surgery
Primary	concentration of C-Reactive Protein	Blood analysis	week 8
Primary	concentration of Calcium	Blood analysis	- 1 week
Primary	concentration of Calcium	Blood analysis	24 hours after surgery
Primary	concentration of Calcium	Blood analysis	48 hours after surgery
Primary	concentration of Calcium	Blood analysis	week 8
Primary	concentration of Phosphate	Blood analysis	- 1 week
Primary	concentration of Phosphate	Blood analysis	24 hours after surgery
Primary	concentration of Phosphate	Blood analysis	48 hours after surgery
Primary	concentration of Phosphate	Blood analysis	week 8
Primary	concentration of Creatine kinase	Blood analysis	- 1 week
Primary	concentration of Creatine kinase	Blood analysis	24 hours after surgery
Primary	concentration of Creatine kinase	Blood analysis	48 hours after surgery
Primary	concentration of Creatine kinase	Blood analysis	week 8
Primary	concentration of Myoglobine	Blood analysis	- 1 week
Primary	concentration of Myoglobine	Blood analysis	24 hours after surgery
Primary	concentration of Myoglobine	Blood analysis	48 hours after surgery
Primary	concentration of Myoglobine	Blood analysis	week 8
Primary	concentration of Lactate dehydrogenase	Blood analysis	- 1 week
Primary	concentration of Lactate dehydrogenase	Blood analysis	24 hours after surgery
Primary	concentration of Lactate dehydrogenase	Blood analysis	48 hours after surgery
Primary	concentration of Lactate dehydrogenase	Blood analysis	week 8
Primary	concentration of Alkaline phosphatase	Blood analysis	- 1 week
Primary	concentration of Alkaline phosphatase	Blood analysis	24 hours after surgery
Primary	concentration of Alkaline phosphatase	Blood analysis	48 hours after surgery
Primary	concentration of Alkaline phosphatase	Blood analysis	week 8
Secondary	Magnetic Resonance Imaging (MRI)	MRI images will be used to evaluate paraspinal and iliopsoas muscle cross-sectional area (CSA), and functional cross-sectional area (FCSA).	- 1 week
Secondary	Magnetic Resonance Imaging (MRI)	MRI images will be used to evaluate paraspinal and iliopsoas muscle cross-sectional area (CSA), and functional cross-sectional area (FCSA).	week 8
Secondary	DEXA-san (Dual-energy X-ray Absorptiometry).	Participants will undergo a DEXA-scan to evaluate body composition	- 1 week
Secondary	DEXA-san (Dual-energy X-ray Absorptiometry).	Participants will undergo a DEXA-scan to evaluate body composition	week 8
Secondary	activity tracker	Participant will were an activity tracker from -1 week -1 until week 8 to compare activity patterns between groups	From - 1 week up to week 8 (24 hours a day)
Secondary	Visual analogue scale (VAS)	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."	- 1 week
Secondary	Visual analogue scale (VAS)	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."	24 hours after surgery
Secondary	Visual analogue scale (VAS)	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."	48 hours after surgery
Secondary	Visual analogue scale (VAS)	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."	week 8
Secondary	Pain catastrophizing scale (PCS)	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.	- 1 Week
Secondary	Pain catastrophizing scale (PCS)	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.	week 8
Secondary	Pain vigilance and awareness questionnaire (PVAQ)	The PVAQ is a 16-item measure of attention to pain that assesses awareness, consciousness, vigilance, and observation of pain.	- 1 week
Secondary	Pain vigilance and awareness questionnaire (PVAQ)	The PVAQ is a 16-item measure of attention to pain that assesses awareness, consciousness, vigilance, and observation of pain.	week 8
Secondary	Oswestry Disability Index (ODI)	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.	- 1 week
Secondary	Oswestry Disability Index (ODI)	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.	week 8
Secondary	EQ5D questionaire	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.	- 1 week
Secondary	EQ5D questionaire	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.	week 8
Secondary	Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)	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).	- 1 week
Secondary	Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)	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).	week 8
Secondary	The Tampa Scale for Kinesiophobia (TSK)	: 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.	- 1 week
Secondary	The Tampa Scale for Kinesiophobia (TSK)	: 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.	week 8
Secondary	The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	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	- 1 week
Secondary	The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	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 hours after surgery
Secondary	The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	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	48 hours after surgery
Secondary	The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)	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	week 8
Secondary	Dietary intake	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).	up to week 8
Secondary	Blood loss	Surgical blood loss needs to be reported in milliliters.	week o
Secondary	Operating time	Time from the incision until closing of the operating site will be reported.	week o
Secondary	Complications	Bleeding, infection, nerve damage, re-intervention, permanent injuries will be reported	week o