Muscle DamageXLIFNCT04589572
Extreme Lateral Interbody FusionFUSION (XLIF) Versus Posterior Lumbar Interbody Fusion (PLIF)
A study testing XLIF and PLIF in people with Muscle Damage and Atrophy, run by Hasselt University at 3 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Damage, Atrophy, Degenerative Diseases, Spinal Cord
- What is being tested?
- XLIF and PLIF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Jan 2020to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical single level disc degeneration
- Age between 18 and 65 years old
- Understand Dutch (writing and speaking)
- Symptom duration ≤ 5 years
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Jessa Ziekenhuis
Hasselt, 3500
Sint-Franciscus Ziekenhuis
Heusden-Zolder, 3550
Sint-Trudo Ziekenhuis
Sint-Truiden, 3800
About this study
Official title: Structural and Funcional Outcomes of Extreme Lateral Interbody Fusion (XLIF) Compared to Posterior Lumbar Interbody Fusion (PLIF)
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.
Read more
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
- Being tested
- XLIF, PLIF
- Medical subject headings
- Atrophy, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XLIFProcedure or surgery
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.
PLIFProcedure or surgery
open posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) are used to treat degenerative diseases of the spinal column.
| Study group | Role | What they receive |
|---|---|---|
| XLIF - group | Experimental | Not described Receives: Procedure: XLIF |
| PLIF - Group | Active comparator | Not described Receives: Procedure: PLIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: - 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.
Measured: week 8
concentration of C-Reactive Protein
Blood analysis
Measured: - 1 week
concentration of C-Reactive Protein
Blood analysis
Measured: 24 hours after surgery
concentration of C-Reactive Protein
Blood analysis
Measured: 48 hours after surgery
concentration of C-Reactive Protein
Blood analysis
Measured: week 8
concentration of Calcium
Blood analysis
Measured: - 1 week
concentration of Calcium
Blood analysis
Measured: 24 hours after surgery
concentration of Calcium
Blood analysis
Measured: 48 hours after surgery
concentration of Calcium
Blood analysis
Measured: week 8
concentration of Phosphate
Blood analysis
Measured: - 1 week
concentration of Phosphate
Blood analysis
Measured: 24 hours after surgery
concentration of Phosphate
Blood analysis
Measured: 48 hours after surgery
concentration of Phosphate
Blood analysis
Measured: week 8
concentration of Creatine kinase
Blood analysis
Measured: - 1 week
concentration of Creatine kinase
Blood analysis
Measured: 24 hours after surgery
concentration of Creatine kinase
Blood analysis
Measured: 48 hours after surgery
concentration of Creatine kinase
Blood analysis
Measured: week 8
concentration of Myoglobine
Blood analysis
Measured: - 1 week
concentration of Myoglobine
Blood analysis
Measured: 24 hours after surgery
concentration of Myoglobine
Blood analysis
Measured: 48 hours after surgery
concentration of Myoglobine
Blood analysis
Measured: week 8
concentration of Lactate dehydrogenase
Blood analysis
Measured: - 1 week
concentration of Lactate dehydrogenase
Blood analysis
Measured: 24 hours after surgery
concentration of Lactate dehydrogenase
Blood analysis
Measured: 48 hours after surgery
concentration of Lactate dehydrogenase
Blood analysis
Measured: week 8
concentration of Alkaline phosphatase
Blood analysis
Measured: - 1 week
concentration of Alkaline phosphatase
Blood analysis
Measured: 24 hours after surgery
concentration of Alkaline phosphatase
Blood analysis
Measured: 48 hours after surgery
concentration of Alkaline phosphatase
Blood analysis
Measured: week 8
Secondary outcomes (29)
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).
Measured: - 1 week
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).
Measured: week 8
DEXA-san (Dual-energy X-ray Absorptiometry).
Participants will undergo a DEXA-scan to evaluate body composition
Measured: - 1 week
DEXA-san (Dual-energy X-ray Absorptiometry).
Participants will undergo a DEXA-scan to evaluate body composition
Measured: week 8
activity tracker
Participant will were an activity tracker from -1 week -1 until week 8 to compare activity patterns between groups
Measured: From - 1 week up to week 8 (24 hours a day)
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."
Measured: - 1 week
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."
Measured: 24 hours after surgery
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."
Measured: 48 hours after surgery
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."
Measured: week 8
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.
Measured: - 1 Week
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.
Measured: week 8
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.
Measured: - 1 week
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.
Measured: week 8
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.
Measured: - 1 week
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.
Measured: week 8
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.
Measured: - 1 week
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.
Measured: week 8
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).
Measured: - 1 week
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).
Measured: week 8
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.
Measured: - 1 week
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.
Measured: week 8
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
Measured: - 1 week
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
Measured: 24 hours after 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
Measured: 48 hours after 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
Measured: week 8
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).
Measured: up to week 8
Blood loss
Surgical blood loss needs to be reported in milliliters.
Measured: week o
Operating time
Time from the incision until closing of the operating site will be reported.
Measured: week o
Complications
Bleeding, infection, nerve damage, re-intervention, permanent injuries will be reported
Measured: week o
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jan 2020
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Why it stopped: Because of COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- EXTREME LATERAL INTERBODY FUSION (XLIF) VERSUS POSTERIOR LUMBAR INTERBODY FUSION (PLIF)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, Sint-Trudo Hospital, Sint-Franciscus Ziekenhuis
- Responsible party
- Principal investigator, Frank Vandenabeele, Hasselt University
- Investigators
- Frank Vandenabeele, prof. dr., Principal investigator, Hasselt UniversitySjoerd stevens, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589572
- Sponsor's protocol ID
- UH-XLIF-001
- Acronym
- XLIF
- Status last verified
- May 2022
- First submitted
- 16 Jul 2020
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Funcional Outcomes of Extreme Lateral Interbody Fusion (XLIF) Compared to Posterior Lumbar Interbody Fusion (PLIF)
- ClinicalTrials.gov ID
- NCT04589572
- Acronym / sponsor ID
- XLIF / UH-XLIF-001
- Conditions
- Muscle Damage, Atrophy, Degenerative Diseases, Spinal Cord
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Because of COVID-19
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital, Sint-Trudo Hospital, Sint-Franciscus Ziekenhuis
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- EXTREME LATERAL INTERBODY FUSION (XLIF) VERSUS POSTERIOR LUMBAR INTERBODY FUSION (PLIF)
| Arm | Type | Receives |
|---|---|---|
| XLIF - group | Experimental | Procedure: XLIF |
| PLIF - Group | Active comparator | Procedure: PLIF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical single level disc degeneration
- Age between 18 and 65 years old
- Understand Dutch (writing and speaking)
- Symptom duration ≤ 5 years
Key exclusion criteria (7 listed)
- Involvement of the L5-S1 or L2-L3 segment
- Psychiatric pathology/ problems (e.g. substance abuse)
- Pregnancy
- Being non-suitable for surgery
- BMI ≥35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XLIFthe 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. | Procedure or surgery | XLIF - group |
| PLIFopen posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) are used to treat degenerative diseases of the spinal column. | Procedure or surgery | PLIF - Group |
Primary outcome
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.
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: - 1 week
Blood analysis
concentration of C-Reactive Protein
Time frame: 24 hours after surgery
Blood analysis
concentration of C-Reactive Protein
Time frame: 48 hours after surgery
Blood analysis
concentration of C-Reactive Protein
Time frame: week 8
Blood analysis
concentration of Calcium
Time frame: - 1 week
Blood analysis
concentration of Calcium
Time frame: 24 hours after surgery
Blood analysis
concentration of Calcium
Time frame: 48 hours after surgery
Blood analysis
concentration of Calcium
Time frame: week 8
Blood analysis
concentration of Phosphate
Time frame: - 1 week
Blood analysis
concentration of Phosphate
Time frame: 24 hours after surgery
Blood analysis
concentration of Phosphate
Time frame: 48 hours after surgery
Blood analysis
concentration of Phosphate
Time frame: week 8
Blood analysis
concentration of Creatine kinase
Time frame: - 1 week
Blood analysis
concentration of Creatine kinase
Time frame: 24 hours after surgery
Blood analysis
concentration of Creatine kinase
Time frame: 48 hours after surgery
Blood analysis
concentration of Creatine kinase
Time frame: week 8
Blood analysis
concentration of Myoglobine
Time frame: - 1 week
Blood analysis
concentration of Myoglobine
Time frame: 24 hours after surgery
Blood analysis
concentration of Myoglobine
Time frame: 48 hours after surgery
Blood analysis
concentration of Myoglobine
Time frame: week 8
Blood analysis
concentration of Lactate dehydrogenase
Time frame: - 1 week
Blood analysis
concentration of Lactate dehydrogenase
Time frame: 24 hours after surgery
Blood analysis
concentration of Lactate dehydrogenase
Time frame: 48 hours after surgery
Blood analysis
concentration of Lactate dehydrogenase
Time frame: week 8
Blood analysis
concentration of Alkaline phosphatase
Time frame: - 1 week
Blood analysis
concentration of Alkaline phosphatase
Time frame: 24 hours after surgery
Blood analysis
concentration of Alkaline phosphatase
Time frame: 48 hours after surgery
Blood analysis
concentration of Alkaline phosphatase
Time frame: week 8
Blood analysis
29 secondary outcomes
Magnetic Resonance Imaging (MRI)
Time frame: - 1 week
Magnetic Resonance Imaging (MRI)
Time frame: week 8
DEXA-san (Dual-energy X-ray Absorptiometry).
Time frame: - 1 week
DEXA-san (Dual-energy X-ray Absorptiometry).
Time frame: week 8
activity tracker
Time frame: From - 1 week up to week 8 (24 hours a day)
Visual analogue scale (VAS)
Time frame: - 1 week
Visual analogue scale (VAS)
Time frame: 24 hours after surgery
Visual analogue scale (VAS)
Time frame: 48 hours after surgery
Visual analogue scale (VAS)
Time frame: week 8
Pain catastrophizing scale (PCS)
Time frame: - 1 Week
Pain catastrophizing scale (PCS)
Time frame: week 8
Pain vigilance and awareness questionnaire (PVAQ)
Time frame: - 1 week
Pain vigilance and awareness questionnaire (PVAQ)
Time frame: week 8
Oswestry Disability Index (ODI)
Time frame: - 1 week
Oswestry Disability Index (ODI)
Time frame: week 8
EQ5D questionaire
Time frame: - 1 week
EQ5D questionaire
Time frame: week 8
Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)
Time frame: - 1 week
Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)
Time frame: week 8
The Tampa Scale for Kinesiophobia (TSK)
Time frame: - 1 week
The Tampa Scale for Kinesiophobia (TSK)
Time frame: week 8
The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time frame: - 1 week
The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time frame: 24 hours after surgery
The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time frame: 48 hours after surgery
The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time frame: week 8
Dietary intake
Time frame: up to week 8
Blood loss
Time frame: week o
Operating time
Time frame: week o
Complications
Time frame: week o
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Vandenabeele, prof. dr. principal investigator
Hasselt University
Sjoerd stevens, drs. study chair
Hasselt University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XLIF and PLIF in people with Muscle Damage and Atrophy, run by Hasselt University at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paraspinal muscle biopsy (time frame: - 1 week). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.