Direct Repair Surgery for Spondylolysis of Lumbar in Young Population

Spondylolysis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129374
• Other study ID #: DR-001
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: May 2, 2014
• Start date: January 2014
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spondylolysis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Armed Forces Yangju Hospital	Yangju	Gyounggido

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Union rate using dynamic radiographs and CT scans	union rate at postoperative 1 year was evaluated using dynamic radiographs and computed tomography (CT) scans.	Postoperative 1 year	No
Secondary	Pain intensity on VAS	Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.	postoperative 3 months	No
Secondary	Pain intensity on VAS	Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.	postoperative 6 months	No
Secondary	Pain intensity on VAS	Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.	postoperative 12 months	No
Secondary	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.	Postoperative 3 months	No
Secondary	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.	Postoperative 6 months	No
Secondary	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.	Postoperative 12 months	No