Lumbar Foraminal StenosisNCT05140733
Outcomes of Patients With Foraminal Stenosis
An observational study of Lumbar Foraminal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The present study was to see the effect of minimally invasive neural foraminotomy for lumbar foraminal stenosis with unilateral radicular pain. Traditionally, fusion was was done for the patients, but recent development enable surgeon to decompress neural foramen without rigid spinal fusion. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Lumbar Foraminal Stenosis
- What is being tested?
- lumbar foraminal decompression and Fusion surgery
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Aug 2021to 28 Feb 2024
- Phase
- Observational
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: 26 patients in each foraminotomy and fusion group.
Who may be able to join
- patients between 40 - 100 years.
- No improvement despite nonsurgical treatment for more than 3 months.
- No history of lumbar fusion surgery.
- Single or double-level lumbar foraminal stenosis with corresponding leg pain
Who cannot join
- Severe neurological deficit (motor grade less than Grade III)
- Combined inflammatory joint disease
- Combined neurodegenerative disease such as Parkinson's disease or dementia * Combined cancer, traumatic fracture
- Marked spinal deformity (C7 sagittal vertical axis > 10cm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-effectiveness Analysis Between Lumbar Foraminotomy and Lumbar Single or Double Levels Fusion Surgery in Patients With Foraminal Stenosis
The present study was to see the effect of minimally invasive neural foraminotomy for lumbar foraminal stenosis with unilateral radicular pain. Traditionally, fusion was was done for the patients, but recent development enable surgeon to decompress neural foramen without rigid spinal fusion. Although, clinical effect of neural foraminotomy may have limitation in attaining a comparable result to fusion surgery, a cost-effective analysis may reveal a result in a different perspective. In this regard, we designed a prospective cohort study to see the cost-effectiveness of neural foraminotomy compared to fusion surgery.
Read the detailed description
Control: 1-2 levels fusion surgery Intervention: neural foraminotomy
Inclusion patients between 40 - 100 years. No improvement despite nonsurgical treatment for more than 3 months. No history of lumbar fusion surgery Single or double-level lumbar foraminal stenosis with corresponding leg pain
Exclusion Severe neurological deficit (motor grade less than Grade III) Combined inflammatory joint disease Combined neurodegenerative disease such as Parkinson's disease or dementia Combined cancer, traumatic fracture marked spinal deformity (C7 sagittal vertical axis > 10cm)
Surgery and follow-up Patients underwent foraminotomy and visits outpatient clinical at determined time points (postoperative month 1, 6, 12 and 24 months) Their clinical outcomes were recorded at each visit. Their medical costs were retrieved at the time of analysis by using hospital records.
Statistical analysis means: T-test
- Conditions
- Lumbar Foraminal Stenosis
- Being tested
- lumbar foraminal decompression, Fusion surgery
- Keywords
- Cost-effectiveness, surgery, deformity
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar foraminal decompressionProcedure or surgery
lumbar foraminal decompression with endoscopic instruments.
Fusion surgeryProcedure or surgery
Fusion surgery for patients with foraminal stenosis
| Study group | Role | What they receive |
|---|---|---|
| Fusion | 1 or 2 levels fusion surgery Receives: Procedure: Fusion surgery | |
| Foraminotomy | 1 or 2 levels lumbar foraminotomy Receives: Procedure: lumbar foraminal decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness
cost to increased one quality adjusted life year (QALY) after surgical treatment
Measured: preoperation
Cost-effectiveness
cost to increased one quality adjusted life year (QALY) after surgical treatment
Measured: postoperative 6 months
Cost-effectiveness
cost to increased one quality adjusted life year (QALY) after surgical treatment
Measured: postoperative 1 year
Cost-effectiveness
cost to increased one quality adjusted life year (QALY) after surgical treatment
Measured: postoperative 2 years
Secondary outcomes (8)
Oswestry disability index (ODI)
ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.
Measured: preoperation
Oswestry disability index (ODI)
ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.
Measured: postoperative 6 months
Oswestry disability index (ODI)
ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.
Measured: postoperative 1 year
Oswestry disability index (ODI)
ODI was recorded at preoperation, postoperative 6 months, 1 year and 2 years.
Measured: postoperative 2 years
Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.
Numeric rating scale (NRS)
: Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain.
Measured: preoperation
Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.
Numeric rating scale (NRS)
: Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain.
Measured: postoperative 6 months
Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.
Numeric rating scale (NRS)
: Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain.
Measured: postoperative 1 year
Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
NRS-B and NRS-L were recorded at preoperation, postoperative 6 months, 1 year and 2 years.
Numeric rating scale (NRS)
: Scale from 0 to 10. Zero means there's no pain and 10 means the maximum pain.
Measured: postoperative 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start22 Aug 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Foraminal StenosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Heon Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140733
- Sponsor's protocol ID
- Foraminotomy
- Status last verified
- Mar 2024
- First submitted
- 22 Aug 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I am willing to share all data after publication.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Analysis Between Lumbar Foraminotomy and Lumbar Single or Double Levels Fusion Surgery in Patients With Foraminal Stenosis
- ClinicalTrials.gov ID
- NCT05140733
- Acronym / sponsor ID
- Foraminotomy
- Conditions
- Lumbar Foraminal Stenosis
- Keywords
- Cost-effectiveness, surgery, deformity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Aug 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 1 Dec 2021 (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.
The present study was to see the effect of minimally invasive neural foraminotomy for lumbar foraminal stenosis with unilateral radicular pain. Traditionally, fusion was was done for the patients, but recent development enable surgeon to decompress neural foramen without rigid spinal fusion. Although, clinical effect of neural foraminotomy may have limitation in attaining a comparable result to fusion surgery, a cost-effective analysis may reveal a result in a different perspective. In this regard, we designed a prospective cohort study to see the cost-effectiveness of neural foraminotomy compared to fusion surgery.
Detailed description
Control: 1-2 levels fusion surgery Intervention: neural foraminotomy
Inclusion patients between 40 - 100 years. No improvement despite nonsurgical treatment for more than 3 months. No history of lumbar fusion surgery Single or double-level lumbar foraminal stenosis with corresponding leg pain
Exclusion Severe neurological deficit (motor grade less than Grade III) Combined inflammatory joint disease Combined neurodegenerative disease such as Parkinson's disease or dementia Combined cancer, traumatic fracture marked spinal deformity (C7 sagittal vertical axis > 10cm)
Surgery and follow-up Patients underwent foraminotomy and visits outpatient clinical at determined time points (postoperative month 1, 6, 12 and 24 months) Their clinical outcomes were recorded at each visit. Their medical costs were retrieved at the time of analysis by using hospital records.
Statistical analysis means: T-test
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fusion | – | Procedure: Fusion surgery1 or 2 levels fusion surgery |
| Foraminotomy | – | Procedure: lumbar foraminal decompression1 or 2 levels lumbar foraminotomy |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 26 patients in each foraminotomy and fusion group.
Key inclusion criteria (4 listed)
- patients between 40 - 100 years.
- No improvement despite nonsurgical treatment for more than 3 months.
- No history of lumbar fusion surgery.
- Single or double-level lumbar foraminal stenosis with corresponding leg pain
Key exclusion criteria (4 listed)
- Severe neurological deficit (motor grade less than Grade III)
- Combined inflammatory joint disease
- Combined neurodegenerative disease such as Parkinson's disease or dementia * Combined cancer, traumatic fracture
- Marked spinal deformity (C7 sagittal vertical axis > 10cm)
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 |
|---|---|---|
| lumbar foraminal decompressionlumbar foraminal decompression with endoscopic instruments. | Procedure or surgery | Foraminotomy |
| Fusion surgeryFusion surgery for patients with foraminal stenosis | Procedure or surgery | Fusion |
Primary outcome
Cost-effectiveness
Time frame: preoperation
cost to increased one quality adjusted life year (QALY) after surgical treatment
Cost-effectiveness
Time frame: postoperative 6 months
cost to increased one quality adjusted life year (QALY) after surgical treatment
Cost-effectiveness
Time frame: postoperative 1 year
cost to increased one quality adjusted life year (QALY) after surgical treatment
Cost-effectiveness
Time frame: postoperative 2 years
cost to increased one quality adjusted life year (QALY) after surgical treatment
8 secondary outcomes
Oswestry disability index (ODI)
Time frame: preoperation
Oswestry disability index (ODI)
Time frame: postoperative 6 months
Oswestry disability index (ODI)
Time frame: postoperative 1 year
Oswestry disability index (ODI)
Time frame: postoperative 2 years
Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
Time frame: preoperation
Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
Time frame: postoperative 6 months
Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
Time frame: postoperative 1 year
Numeric rating scale(NRS) of pain on back (NRS-B) and legs (NRS-L)
Time frame: postoperative 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Yes. I am willing to share all data after publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Foraminal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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: finished, as of the sponsor's last update on 15 Mar 2024. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cost-effectiveness (time frame: preoperation). The study lists 4 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 15 Mar 2024.