Extreme Lateral Interbody FusionFUSION (XLIF) Versus Posterior Lumbar Interbody Fusion (PLIF) (XLIF)
Primary Purpose
Muscle Damage, Atrophy, Degenerative Diseases, Spinal Cord
Status
Suspended
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
XLIF
PLIF
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Damage
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)
Sites / Locations
- Jessa Ziekenhuis
- Sint-Franciscus Ziekenhuis
- Sint-Trudo Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
XLIF - group
PLIF - Group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
concentration of C-Reactive Protein
Blood analysis
concentration of C-Reactive Protein
Blood analysis
concentration of C-Reactive Protein
Blood analysis
concentration of C-Reactive Protein
Blood analysis
concentration of Calcium
Blood analysis
concentration of Calcium
Blood analysis
concentration of Calcium
Blood analysis
concentration of Calcium
Blood analysis
concentration of Phosphate
Blood analysis
concentration of Phosphate
Blood analysis
concentration of Phosphate
Blood analysis
concentration of Phosphate
Blood analysis
concentration of Creatine kinase
Blood analysis
concentration of Creatine kinase
Blood analysis
concentration of Creatine kinase
Blood analysis
concentration of Creatine kinase
Blood analysis
concentration of Myoglobine
Blood analysis
concentration of Myoglobine
Blood analysis
concentration of Myoglobine
Blood analysis
concentration of Myoglobine
Blood analysis
concentration of Lactate dehydrogenase
Blood analysis
concentration of Lactate dehydrogenase
Blood analysis
concentration of Lactate dehydrogenase
Blood analysis
concentration of Lactate dehydrogenase
Blood analysis
concentration of Alkaline phosphatase
Blood analysis
concentration of Alkaline phosphatase
Blood analysis
concentration of Alkaline phosphatase
Blood analysis
concentration of Alkaline phosphatase
Blood analysis
Secondary Outcome Measures
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).
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).
DEXA-san (Dual-energy X-ray Absorptiometry).
Participants will undergo a DEXA-scan to evaluate body composition
DEXA-san (Dual-energy X-ray Absorptiometry).
Participants will undergo a DEXA-scan to evaluate body composition
activity tracker
Participant will were an activity tracker from -1 week -1 until week 8 to compare activity patterns between groups
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."
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."
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."
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."
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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
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
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
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
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).
Blood loss
Surgical blood loss needs to be reported in milliliters.
Operating time
Time from the incision until closing of the operating site will be reported.
Complications
Bleeding, infection, nerve damage, re-intervention, permanent injuries will be reported
Full Information
NCT ID
NCT04589572
First Posted
July 16, 2020
Last Updated
May 18, 2022
Sponsor
Hasselt University
Collaborators
Jessa Hospital, Sint-Trudo Hospital, Sint-Franciscus Ziekenhuis
1. Study Identification
Unique Protocol Identification Number
NCT04589572
Brief Title
Extreme Lateral Interbody FusionFUSION (XLIF) Versus Posterior Lumbar Interbody Fusion (PLIF)
Acronym
XLIF
Official Title
Structural and Funcional Outcomes of Extreme Lateral Interbody Fusion (XLIF) Compared to Posterior Lumbar Interbody Fusion (PLIF)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Suspended
Why Stopped
Because of COVID-19
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital, Sint-Trudo Hospital, Sint-Franciscus Ziekenhuis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Damage, Atrophy, Degenerative Diseases, Spinal Cord
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
EXTREME LATERAL INTERBODY FUSION (XLIF) VERSUS POSTERIOR LUMBAR INTERBODY FUSION (PLIF)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XLIF - group
Arm Type
Experimental
Arm Title
PLIF - Group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
XLIF
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PLIF
Intervention Description
open posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) are used to treat degenerative diseases of the spinal column.
Primary Outcome Measure Information:
Title
Paraspinal muscle biopsy
Description
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.
Time Frame
- 1 week
Title
Paraspinal muscle biopsy
Description
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.
Time Frame
week 8
Title
concentration of C-Reactive Protein
Description
Blood analysis
Time Frame
- 1 week
Title
concentration of C-Reactive Protein
Description
Blood analysis
Time Frame
24 hours after surgery
Title
concentration of C-Reactive Protein
Description
Blood analysis
Time Frame
48 hours after surgery
Title
concentration of C-Reactive Protein
Description
Blood analysis
Time Frame
week 8
Title
concentration of Calcium
Description
Blood analysis
Time Frame
- 1 week
Title
concentration of Calcium
Description
Blood analysis
Time Frame
24 hours after surgery
Title
concentration of Calcium
Description
Blood analysis
Time Frame
48 hours after surgery
Title
concentration of Calcium
Description
Blood analysis
Time Frame
week 8
Title
concentration of Phosphate
Description
Blood analysis
Time Frame
- 1 week
Title
concentration of Phosphate
Description
Blood analysis
Time Frame
24 hours after surgery
Title
concentration of Phosphate
Description
Blood analysis
Time Frame
48 hours after surgery
Title
concentration of Phosphate
Description
Blood analysis
Time Frame
week 8
Title
concentration of Creatine kinase
Description
Blood analysis
Time Frame
- 1 week
Title
concentration of Creatine kinase
Description
Blood analysis
Time Frame
24 hours after surgery
Title
concentration of Creatine kinase
Description
Blood analysis
Time Frame
48 hours after surgery
Title
concentration of Creatine kinase
Description
Blood analysis
Time Frame
week 8
Title
concentration of Myoglobine
Description
Blood analysis
Time Frame
- 1 week
Title
concentration of Myoglobine
Description
Blood analysis
Time Frame
24 hours after surgery
Title
concentration of Myoglobine
Description
Blood analysis
Time Frame
48 hours after surgery
Title
concentration of Myoglobine
Description
Blood analysis
Time Frame
week 8
Title
concentration of Lactate dehydrogenase
Description
Blood analysis
Time Frame
- 1 week
Title
concentration of Lactate dehydrogenase
Description
Blood analysis
Time Frame
24 hours after surgery
Title
concentration of Lactate dehydrogenase
Description
Blood analysis
Time Frame
48 hours after surgery
Title
concentration of Lactate dehydrogenase
Description
Blood analysis
Time Frame
week 8
Title
concentration of Alkaline phosphatase
Description
Blood analysis
Time Frame
- 1 week
Title
concentration of Alkaline phosphatase
Description
Blood analysis
Time Frame
24 hours after surgery
Title
concentration of Alkaline phosphatase
Description
Blood analysis
Time Frame
48 hours after surgery
Title
concentration of Alkaline phosphatase
Description
Blood analysis
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Magnetic Resonance Imaging (MRI)
Description
MRI images will be used to evaluate paraspinal and iliopsoas muscle cross-sectional area (CSA), and functional cross-sectional area (FCSA).
Time Frame
- 1 week
Title
Magnetic Resonance Imaging (MRI)
Description
MRI images will be used to evaluate paraspinal and iliopsoas muscle cross-sectional area (CSA), and functional cross-sectional area (FCSA).
Time Frame
week 8
Title
DEXA-san (Dual-energy X-ray Absorptiometry).
Description
Participants will undergo a DEXA-scan to evaluate body composition
Time Frame
- 1 week
Title
DEXA-san (Dual-energy X-ray Absorptiometry).
Description
Participants will undergo a DEXA-scan to evaluate body composition
Time Frame
week 8
Title
activity tracker
Description
Participant will were an activity tracker from -1 week -1 until week 8 to compare activity patterns between groups
Time Frame
From - 1 week up to week 8 (24 hours a day)
Title
Visual analogue scale (VAS)
Description
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."
Time Frame
- 1 week
Title
Visual analogue scale (VAS)
Description
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."
Time Frame
24 hours after surgery
Title
Visual analogue scale (VAS)
Description
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."
Time Frame
48 hours after surgery
Title
Visual analogue scale (VAS)
Description
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."
Time Frame
week 8
Title
Pain catastrophizing scale (PCS)
Description
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.
Time Frame
- 1 Week
Title
Pain catastrophizing scale (PCS)
Description
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.
Time Frame
week 8
Title
Pain vigilance and awareness questionnaire (PVAQ)
Description
The PVAQ is a 16-item measure of attention to pain that assesses awareness, consciousness, vigilance, and observation of pain.
Time Frame
- 1 week
Title
Pain vigilance and awareness questionnaire (PVAQ)
Description
The PVAQ is a 16-item measure of attention to pain that assesses awareness, consciousness, vigilance, and observation of pain.
Time Frame
week 8
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
- 1 week
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
week 8
Title
EQ5D questionaire
Description
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.
Time Frame
- 1 week
Title
EQ5D questionaire
Description
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.
Time Frame
week 8
Title
Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)
Description
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).
Time Frame
- 1 week
Title
Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)
Description
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).
Time Frame
week 8
Title
The Tampa Scale for Kinesiophobia (TSK)
Description
: 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.
Time Frame
- 1 week
Title
The Tampa Scale for Kinesiophobia (TSK)
Description
: 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.
Time Frame
week 8
Title
The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Description
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
Time Frame
- 1 week
Title
The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Description
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
Time Frame
24 hours after surgery
Title
The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Description
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
Time Frame
48 hours after surgery
Title
The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Description
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
Time Frame
week 8
Title
Dietary intake
Description
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).
Time Frame
up to week 8
Title
Blood loss
Description
Surgical blood loss needs to be reported in milliliters.
Time Frame
week o
Title
Operating time
Description
Time from the incision until closing of the operating site will be reported.
Time Frame
week o
Title
Complications
Description
Bleeding, infection, nerve damage, re-intervention, permanent injuries will be reported
Time Frame
week o
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Vandenabeele, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sjoerd stevens, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Sint-Franciscus Ziekenhuis
City
Heusden-Zolder
ZIP/Postal Code
3550
Country
Belgium
Facility Name
Sint-Trudo Ziekenhuis
City
Sint-Truiden
ZIP/Postal Code
3800
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Extreme Lateral Interbody FusionFUSION (XLIF) Versus Posterior Lumbar Interbody Fusion (PLIF)
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