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Direct Repair Surgery for Spondylolysis of Lumbar in Young Population

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02129374
Enrollment
163
Registered
2014-05-02
Start date
2014-01-31
Completion date
2014-04-30
Last updated
2014-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylolysis

Keywords

Spondylolysis, Lumbar spine, Young population, Direct repair, Union rate, Functional outcome

Brief 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 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.

Interventions

PROCEDUREDirect repair of pars defect

Direct repair at pars defect was performed with 4.5mm cortical screw in young spondylolytic patients.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Union rate using dynamic radiographs and CT scansPostoperative 1 yearunion rate at postoperative 1 year was evaluated using dynamic radiographs and computed tomography (CT) scans.

Secondary

MeasureTime frameDescription
Pain intensity on VASpostoperative 3 monthsPain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.
Functional outcome on ODI and SF-12Postoperative 3 monthsFunctional outcome using oswestry disability index (ODI) and 12-item short form health survey (SF-12) was evaluated separately at the postoperative 3 months.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026