SpondylolysisNCT02129374
Direct Repair Surgery for Spondylolysis of Lumbar in Young Population
A study testing Direct repair of pars defect in people with Spondylolysis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Lumbar spondylolysis is a relatively common condition that causes severe and perennial back pain in young populations. Conservative treatment of this condition may be futile, and may eventually require surgical treatment such as direct repair of pars defect and a segmental lumbar fusion with an anterior or posterior… Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Spondylolysis
- What is being tested?
- Direct repair of pars defect
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Apr 2014
- 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 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients for whom conservative treatment for six months and three-times injection treatments had failed
- a follow-up period of one year or more after surgery
Who cannot join
- patients with abnormal muscle activity or ambulation such as parkinsonism and neuromuscular disease.
- patient inability to accurately record results of preoperative and postoperative questionnaires due to problems such as a history of stroke, dementia, or major medical illness that required intensive treatment
- patient follow-up was limited to one year or less
Trial locations and contacts
1 site in 1 country.
About this study
Lumbar spondylolysis is a relatively common condition that causes severe and perennial back pain in young populations. Conservative treatment of this condition may be futile, and may eventually require surgical treatment such as direct repair of pars defect and a segmental lumbar fusion with an anterior or posterior approach. Recently, of surgical treatment methods for spondylolysis, direct repair surgery of pars defect has been focused due to its inherited strengths. Most importantly, fusion surgery caused the affected segment to lose the nature range of motion and furthermore adjacent segment to be adversely affecting such as adjacent disc disease or degeneration, while direct repair theoretically could preserve the motion of the affected segment, which do not cause the adjacent segment problems as being the fusion surgery, as well as could produce better surgical outcomes with relatively less invasive technique as compared to fusion surgery. Moreover, previous articles have demonstrated that the direct repair surgery for spondylolysis of lumbar spine could achieve great functional and radiological outcomes. However, most of the previous studies was conducted using lower level designed study such as retrospective and small sample size, thereby prior literature does not provide clear information on the therapeutic outcome of direct repair for lumbar spondylolysis, especially for managing spondylolysis of young population.
Therefore, The investigators aimed to evaluate and determine the outcomes of direct repair surgery for lumbar spondylolysis in young population. To our knowledge, this is the first report that describes the functional and radiological outcomes of direct repair for spondylolysis in young populations with prospective cohort study design and relatively large sample size.
- Conditions
- Spondylolysis
- Being tested
- Direct repair of pars defect
- Keywords
- Spondylolysis, Lumbar spine, Young population, Direct repair, Union rate, Functional outcome
- Medical subject headings
- Spondylolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct repair of pars defectProcedure or surgery
Also called 4.5mm cortical screw
Direct repair at pars defect was performed with 4.5mm cortical screw in young spondylolytic patients.
| Study group | Role | What they receive |
|---|---|---|
| Direct repair of pars defect | Experimental | The pars defect was repaired with 4.5mm cortical screw. Receives: Procedure: Direct repair of pars defect |
| Conservative treatment | No intervention | The pars defect of spondylolysis was not repaired with cortical screw. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Union rate using dynamic radiographs and CT scans
union rate at postoperative 1 year was evaluated using dynamic radiographs and computed tomography (CT) scans.
Measured: Postoperative 1 year
Secondary outcomes (6)
Pain intensity on VAS
Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.
Measured: postoperative 3 months
Pain intensity on VAS
Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.
Measured: postoperative 6 months
Pain intensity on VAS
Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.
Measured: postoperative 12 months
Functional outcome on ODI and SF-12
Functional outcome using oswestry disability index (ODI) and 12-item short form health survey (SF-12) was evaluated separately at the postoperative 3 months.
Measured: Postoperative 3 months
Functional outcome on ODI and SF-12
Functional outcome using oswestry disability index (ODI) and 12-item short form health survey (SF-12) was evaluated separately at the postoperative 3 months.
Measured: Postoperative 6 months
Functional outcome on ODI and SF-12
Functional outcome using oswestry disability index (ODI) and 12-item short form health survey (SF-12) was evaluated separately at the postoperative 3 months.
Measured: Postoperative 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylolysisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin S. Yeom, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129374
- Sponsor's protocol ID
- DR-001
- Status last verified
- May 2014
- First submitted
- 30 Apr 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Repair Surgery for Spondylolysis of Lumbar in Young Population
- ClinicalTrials.gov ID
- NCT02129374
- Acronym / sponsor ID
- DR-001
- Conditions
- Spondylolysis
- Keywords
- Spondylolysis, Lumbar spine, Young population, Direct repair, Union rate, Functional outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 2 May 2014 (estimated)
- 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.
Lumbar spondylolysis is a relatively common condition that causes severe and perennial back pain in young populations. Conservative treatment of this condition may be futile, and may eventually require surgical treatment such as direct repair of pars defect and a segmental lumbar fusion with an anterior or posterior approach. Recently, of surgical treatment methods for spondylolysis, direct repair surgery of pars defect has been focused due to its inherited strengths. Most importantly, fusion surgery caused the affected segment to lose the nature range of motion and furthermore adjacent segment to be adversely affecting such as adjacent disc disease or degeneration, while direct repair theoretically could preserve the motion of the affected segment, which do not cause the adjacent segment problems as being the fusion surgery, as well as could produce better surgical outcomes with relatively less invasive technique as compared to fusion surgery. Moreover, previous articles have demonstrated that the direct repair surgery for spondylolysis of lumbar spine could achieve great functional and radiological outcomes. However, most of the previous studies was conducted using lower level designed study such as retrospective and small sample size, thereby prior literature does not provide clear information on the therapeutic outcome of direct repair for lumbar spondylolysis, especially for managing spondylolysis of young population.
Therefore, The investigators aimed to evaluate and determine the outcomes of direct repair surgery for lumbar spondylolysis in young population. To our knowledge, this is the first report that describes the functional and radiological outcomes of direct repair for spondylolysis in young populations with prospective cohort study design and relatively large sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct repair of pars defect | Experimental | Procedure: Direct repair of pars defectThe pars defect was repaired with 4.5mm cortical screw. |
| Conservative treatment | No intervention | –The pars defect of spondylolysis was not repaired with cortical screw. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients for whom conservative treatment for six months and three-times injection treatments had failed
- a follow-up period of one year or more after surgery
Key exclusion criteria (3 listed)
- patients with abnormal muscle activity or ambulation such as parkinsonism and neuromuscular disease.
- patient inability to accurately record results of preoperative and postoperative questionnaires due to problems such as a history of stroke, dementia, or major medical illness that required intensive treatment
- patient follow-up was limited to one year or less
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 |
|---|---|---|
| Direct repair of pars defectAlso: 4.5mm cortical screwDirect repair at pars defect was performed with 4.5mm cortical screw in young spondylolytic patients. | Procedure or surgery | Direct repair of pars defect |
Primary outcome
Union rate using dynamic radiographs and CT scans
Time frame: Postoperative 1 year
union rate at postoperative 1 year was evaluated using dynamic radiographs and computed tomography (CT) scans.
6 secondary outcomes
Pain intensity on VAS
Time frame: postoperative 3 months
Pain intensity on VAS
Time frame: postoperative 6 months
Pain intensity on VAS
Time frame: postoperative 12 months
Functional outcome on ODI and SF-12
Time frame: Postoperative 3 months
Functional outcome on ODI and SF-12
Time frame: Postoperative 6 months
Functional outcome on ODI and SF-12
Time frame: Postoperative 12 months
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 6 May 2014.
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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?
A study testing Direct repair of pars defect in people with Spondylolysis, 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 2 inclusion and 3 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 6 May 2014. 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?
Union rate using dynamic radiographs and CT scans (time frame: Postoperative 1 year). 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 6 May 2014.