Stenoses, SpinalSizeNCT03480893
Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication
A study testing small size interarcuair decompression and Laminectomy in people with Stenoses, Spinal, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Minimally invasive techniques have gained popularity to decompress lumbar spinal stenosis in the elderly. However, high quality evidence based on randomised controlled trials are not available. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stenoses, Spinal
- What is being tested?
- small size interarcuair decompression and Laminectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2020to 1 Apr 2024
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 12 weeks of complaints of INC
- Magnetic resonance imaging showing LSS
- Age >40 years of age
- Sufficient knowledge of the Dutch language
- Signed informed consent
Who cannot join
- History of lumbar spine surgery
- >2 lumbar levels operation or needed discectomy
- Degenerative spondylolisthesis > grade 1 (on a scale of 1 to 4), scoliosis or disc herniation
- ASA-classification >3
- Serious psychopathology
- Pregnancy
- Active malignancy
- Plans to move abroad during study period
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015 CE
Pravesh Gadjradj, p.gadjradj@erasmusmc.nl
Biswadjiet Harhangi
About this study
Official title: Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication (Size-study): a Multi-center, Double-blinded Randomized Controlled Trial
Rationale: Minimally invasive techniques have gained popularity to decompress lumbar spinal stenosis in the elderly. However, high quality evidence based on randomised controlled trials are not available.
Objective: To investigate whether small size interarcuair decompression is more effective than conventional laminectomy in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis. Study design: Double-blinded multi-centre randomised controlled trial Study population: In total 236 patients are to be included. The inclusion criteria are: subjects > 40 years of age with at least 12 weeks of complaints of intermittent neurogenic claudication based on MRI confirmed of LSS, with sufficient knowledge of the Dutch language.
Read more
Intervention: Small size interarcuair decompression versus conventional laminectomy.
Main study parameters/endpoints: Primary outcome is the Modified Roland Morris Questionnaire. Secondary outcomes are leg pain, back pain and a 6 minute walk test amongst others.
Nature and extent of the burden and risks associated with participation: based on available literature , it is believed that the risks associated with small size interarcuair decompression are no greater than that associated with a laminectomy, although these will be examined.
Read the detailed description
Intermittent neurogenic claudication (INC) caused by a lumbar spinal canal stenosis (LSS) is the most frequent reason for spinal surgery in the elderly. Multiple, less invasive surgical techniques are applied without sufficient evidence for benefits for patients or society.
The classic symptoms of INC are leg pain, which can be exacerbated with prolonged walking and standing and/or lumbar extension, and is associated with back pain. Severe stenosis is common in the elderly spine with 30.4% of the population having severe stenosis. However, only 17.5% have complaints of INC.
Conservative treatment, such as physical therapy or pain medication, may give some relief of symptoms. However, surgical treatment is considered to be the gold standard for patients with INC caused by LSS. The first technique ever described to widen the lumbar spinal canal is the wide bony decompression (laminectomy), which is still a widely used technique. However, since INC is often accompanied by back pain, and this to post-operative back pain, it is hypothesized that a wide decompression is a ground for potential instability. Hence, less invasive techniques, such as interarcuair decompression, were developed and implemented.
Recent studies claim that a limited bony decompression is the new 'golden standard' therapy for patients with INC. Limited bony decompression is believed to give less muscle damage and thus a faster postoperative recovery. Furthermore, wide bony decompression (such as a laminectomy) is believed to result in lumbar instability and iatrogenic scoliosis. Performing a procedure with potential more complications in a - generally - elderly population could at least be described as doubtful. The assumption is often made that after a wide decompression recurrence of the complaints must be scarce. However, a (cost-) effectiveness study, which evaluates the effectiveness of small bony decompression compared to a 'classical' extensive bony decompression, has not been performed yet. The opinions on this matter are diverse. A laminectomy involves the removal of more bone and structures at the back of the spine which may result in longer hospitalization and loss of productivity, but it could also lead to spinal instability on the long term. However, the risk of an insufficient decompression may be higher, potentially leading to more reoperations.
By the means of this double-blinded, multi-center randomized controlled trial the investigators will determine the (cost-) effectiveness of a limited bony decompression compared to a wide bony decompression in patients with INC.
- Conditions
- Stenoses, Spinal
- Being tested
- small size interarcuair decompression, Laminectomy
- Keywords
- laminectomy, laminotomy, lumbar canal stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
small size interarcuair decompressionProcedure or surgery
A median lumbar incision is made and the paravertebral muscles are dissected subperiosteally and retracted unilaterally or bilaterally. Decompression will be applied via decompression of the ligamentum flavum. The lateral recess will be opened bilaterally and a medial facetectomy will be performed in order maintain stability of the segments. Posterior ligaments will be spared. The wound will be closed in layers with or without a suction drain. Patients will be operated with a loupe magnification or microscope depending on the surgeon's preference.
LaminectomyProcedure or surgery
A median lumbar incision is made over the spinous processes, the laminae of the affected level(s) are exposed subperiosteally, and the supraspinous ligament will be incised. The spinous process is removed. The supra and interspinous ligament of the affected level is removed by drill or Kerrison punches. The lamen is removed of the affect level, leaving the facet joint intact. The lateral recess will be opened bilaterally and medial facetectomy will be performed in order to maintain stability of the segments. When a single level stenosis is present (e.g. L4-L5) both laminae L4 and L5 will be removed. The wound will be closed in layers with or without a suction drain. Patients will be operated with loupe magnification or microscope depending surgeon's preference.
| Study group | Role | What they receive |
|---|---|---|
| Small size interarcuair decompression | Experimental | Patients will undergo small size interarcuair decompression Receives: Procedure: small size interarcuair decompression |
| Laminectomy | Active comparator | Patients will undergo laminectomy Receives: Procedure: Laminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Modified Roland-Morris Disability Questionnaire
This is a 24-point Dutch questionnaire that is designed to assess the physical disability in patients, due to lower back pain.
Measured: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Secondary outcomes (14)
Change on the Numeric Rating Scale for leg pain
The pain intensity in both legs (affected and non-affected) will be rated on a 11-point scale.
Measured: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Change on the Numeric Rating Scale for back pain
The pain intensity in the back will be rated on a 11-point scale.
Measured: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Changes on the timed-up and go test
This time will be measured in seconds
Measured: baseline, 6 months, 12 months, 24 months and 48 months after surgery
Changes on the 6-minute walk test
The endurance and distance will be measured.
Measured: baseline, 6 months, 12 months, 24 months and 48 months after surgery
Changes on Neurological examination
Motor changes of lower muscles will be measured.
Measured: baseline, 6 months, 12 months, 24 months and 48 months after surgery
Changes on the Timed Chair-Stand-Test (TCST)
The time between standing and sitting on a chair will be measured.
Measured: baseline, 6 months, 12 months, 24 months and 48 months after surgery
Changes on the Oswestry Disability Index
The ODI is one of the principal condition-specific outcome measures used in the management of spinal disorders.
Measured: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Changes on Functional lumbar x-rays
A functional X-ray will be obtained from all patients X-ray will be made from AP and lateral position to assess spondylolisthesis. Degenerative spondylilolisthesis is defined as a vertebral slip of at least 3 mm.
Measured: baseline, 6 weeks
Perceived recovery
- measure the perceived recovery a seven-point Likert scale will be used. The score on this scale vary from 'completely recovered' to 'worse than ever'.
Measured: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Patient satisfaction
To measure patient satisfaction a seven-point Likert scale will be used. The score on this scale vary from 'completely satisfied with current symptoms' to 'completely dissatisfied with current symptoms'.
Measured: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Changes on the SF-36
The SF-36 will be used as a generic quality-of-life questionnaire. The SF-36 questionnaire has been validated and found reliable for low back pain.
Measured: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Complications
A systematic assessment of complications (including wound infection, deep venous thrombosis, urine tract infection, hematoma, and progressive neurological deficit) will be recorded out by the surgeon and research nurse, and these data are to be extracted from the patient chart. Moreover, surgeons will be asked for perioperative complications
Measured: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Changes on the EuroQoL (EQ-5D)
The EuroQoL (EQ-5D) will be used for the cost utility analysis. The tool measures five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each dimension consists of one item, while five levels are distinguished (no, slight, moderate, severe problems, unable to do)
Measured: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Costs of treatment measured using cost questionnaires filled out by the patients
Cost questionnaires will be completed at the prescribed measurements. Hospitalisation for surgery will be registered using the case record forms. Other health care utilization (including physiotherapy, visits to GP and specialists, nursing care and medication), patient costs, and absenteeism from work will be measured using cost questionnaires filled out by the patients.
Measured: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Mar 2020
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stenoses, SpinalStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Park MC, Maasstad Hospital
- Responsible party
- Principal investigator, Pravesh S. Gadjradj, Erasmus Medical Center
- Investigators
- Biswadjiet Harhangi, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480893
- Sponsor's protocol ID
- MRace 108226
- Acronym
- Size
- Status last verified
- Jul 2022
- First submitted
- 17 Mar 2018
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After final publication of manuscript the data set will be available from the authors or journal of publication. Anonymized clinical data will be available.
Publications
Arjun Sharma J, Gadjradj PS, Peul WC, van Tulder MW, Moojen WA, Harhangi BS; SIZE-study group. SIZE study: study protocol of a multicentre, randomised controlled trial to compare the effectiveness of an interarcuair decompression versus extended decompression in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis. BMJ Open. 2020 Oct 6;10(10):e036818. doi: 10.1136/bmjopen-2020-036818.
PubMed 33028548
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication (Size-study): a Multi-center, Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03480893
- Acronym / sponsor ID
- Size / MRace 108226
- Conditions
- Stenoses, Spinal
- Keywords
- laminectomy, laminotomy, lumbar canal stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Park MC, Maasstad Hospital
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 29 Mar 2018 (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.
Rationale: Minimally invasive techniques have gained popularity to decompress lumbar spinal stenosis in the elderly. However, high quality evidence based on randomised controlled trials are not available.
Objective: To investigate whether small size interarcuair decompression is more effective than conventional laminectomy in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis. Study design: Double-blinded multi-centre randomised controlled trial Study population: In total 236 patients are to be included. The inclusion criteria are: subjects > 40 years of age with at least 12 weeks of complaints of intermittent neurogenic claudication based on MRI confirmed of LSS, with sufficient knowledge of the Dutch language.
Intervention: Small size interarcuair decompression versus conventional laminectomy.
Main study parameters/endpoints: Primary outcome is the Modified Roland Morris Questionnaire. Secondary outcomes are leg pain, back pain and a 6 minute walk test amongst others.
Nature and extent of the burden and risks associated with participation: based on available literature , it is believed that the risks associated with small size interarcuair decompression are no greater than that associated with a laminectomy, although these will be examined.
Detailed description
Intermittent neurogenic claudication (INC) caused by a lumbar spinal canal stenosis (LSS) is the most frequent reason for spinal surgery in the elderly. Multiple, less invasive surgical techniques are applied without sufficient evidence for benefits for patients or society.
The classic symptoms of INC are leg pain, which can be exacerbated with prolonged walking and standing and/or lumbar extension, and is associated with back pain. Severe stenosis is common in the elderly spine with 30.4% of the population having severe stenosis. However, only 17.5% have complaints of INC.
Conservative treatment, such as physical therapy or pain medication, may give some relief of symptoms. However, surgical treatment is considered to be the gold standard for patients with INC caused by LSS. The first technique ever described to widen the lumbar spinal canal is the wide bony decompression (laminectomy), which is still a widely used technique. However, since INC is often accompanied by back pain, and this to post-operative back pain, it is hypothesized that a wide decompression is a ground for potential instability. Hence, less invasive techniques, such as interarcuair decompression, were developed and implemented.
Recent studies claim that a limited bony decompression is the new 'golden standard' therapy for patients with INC. Limited bony decompression is believed to give less muscle damage and thus a faster postoperative recovery. Furthermore, wide bony decompression (such as a laminectomy) is believed to result in lumbar instability and iatrogenic scoliosis. Performing a procedure with potential more complications in a - generally - elderly population could at least be described as doubtful. The assumption is often made that after a wide decompression recurrence of the complaints must be scarce. However, a (cost-) effectiveness study, which evaluates the effectiveness of small bony decompression compared to a 'classical' extensive bony decompression, has not been performed yet. The opinions on this matter are diverse. A laminectomy involves the removal of more bone and structures at the back of the spine which may result in longer hospitalization and loss of productivity, but it could also lead to spinal instability on the long term. However, the risk of an insufficient decompression may be higher, potentially leading to more reoperations.
By the means of this double-blinded, multi-center randomized controlled trial the investigators will determine the (cost-) effectiveness of a limited bony decompression compared to a wide bony decompression in patients with INC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small size interarcuair decompression | Experimental | Procedure: small size interarcuair decompressionPatients will undergo small size interarcuair decompression |
| Laminectomy | Active comparator | Procedure: LaminectomyPatients will undergo laminectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 12 weeks of complaints of INC
- Magnetic resonance imaging showing LSS
- Age >40 years of age
- Sufficient knowledge of the Dutch language
- Signed informed consent
Key exclusion criteria (8 listed)
- History of lumbar spine surgery
- >2 lumbar levels operation or needed discectomy
- Degenerative spondylolisthesis > grade 1 (on a scale of 1 to 4), scoliosis or disc herniation
- ASA-classification >3
- Serious psychopathology
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 |
|---|---|---|
| small size interarcuair decompressionA median lumbar incision is made and the paravertebral muscles are dissected subperiosteally and retracted unilaterally or bilaterally. Decompression will be applied via decompression of the ligamentum flavum. The lateral recess will be opened bilaterally and a medial facetectomy will be performed in order maintain stability of the segments. Posterior ligaments will be spared. The wound will be closed in layers with or without a suction drain. Patients will be operated with a loupe magnification or microscope depending on the surgeon's preference. | Procedure or surgery | Small size interarcuair decompression |
| LaminectomyA median lumbar incision is made over the spinous processes, the laminae of the affected level(s) are exposed subperiosteally, and the supraspinous ligament will be incised. The spinous process is removed. The supra and interspinous ligament of the affected level is removed by drill or Kerrison punches. The lamen is removed of the affect level, leaving the facet joint intact. The lateral recess will be opened bilaterally and medial facetectomy will be performed in order to maintain stability of the segments. When a single level stenosis is present (e.g. L4-L5) both laminae L4 and L5 will be removed. The wound will be closed in layers with or without a suction drain. Patients will be operated with loupe magnification or microscope depending surgeon's preference. | Procedure or surgery | Laminectomy |
Primary outcome
Change on the Modified Roland-Morris Disability Questionnaire
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
This is a 24-point Dutch questionnaire that is designed to assess the physical disability in patients, due to lower back pain.
14 secondary outcomes
Change on the Numeric Rating Scale for leg pain
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Change on the Numeric Rating Scale for back pain
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Changes on the timed-up and go test
Time frame: baseline, 6 months, 12 months, 24 months and 48 months after surgery
Changes on the 6-minute walk test
Time frame: baseline, 6 months, 12 months, 24 months and 48 months after surgery
Changes on Neurological examination
Time frame: baseline, 6 months, 12 months, 24 months and 48 months after surgery
Changes on the Timed Chair-Stand-Test (TCST)
Time frame: baseline, 6 months, 12 months, 24 months and 48 months after surgery
Changes on the Oswestry Disability Index
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Changes on Functional lumbar x-rays
Time frame: baseline, 6 weeks
Perceived recovery
Time frame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Patient satisfaction
Time frame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Changes on the SF-36
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Complications
Time frame: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Changes on the EuroQoL (EQ-5D)
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Costs of treatment measured using cost questionnaires filled out by the patients
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 33028548Arjun Sharma J, Gadjradj PS, Peul WC, van Tulder MW, Moojen WA, Harhangi BS; SIZE-study group. SIZE study: study protocol of a multicentre, randomised controlled trial to compare the effectiveness of an interarcuair decompression versus extended decompression in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis. BMJ Open. 2020 Oct 6;10(10):e036818. doi: 10.1136/bmjopen-2020-036818.
- Individual participant dataSharing planned: Yes. After final publication of manuscript the data set will be available from the authors or journal of publication. Anonymized clinical data will be available.
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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.
Biswadjiet Harhangi principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing small size interarcuair decompression and Laminectomy in people with Stenoses, Spinal, run by Erasmus Medical Center at 1 site in Netherlands.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Contact Pravesh Gadjradj (003125689813, p.gadjradj@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the Modified Roland-Morris Disability Questionnaire (time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480893, which also lists 1 linked publication.
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 27 Jul 2022.