Direct Repair Surgery for Spondylolysis of Lumbar in Young Population

NCT ID: NCT02129374

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-04-30

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.

Conditions

Spondylolysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Direct repair of pars defect

The pars defect was repaired with 4.5mm cortical screw.

Group Type: EXPERIMENTAL

Direct repair of pars defect

Intervention Type: PROCEDURE

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

Conservative treatment

The pars defect of spondylolysis was not repaired with cortical screw.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Direct repair of pars defect

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

Intervention Type: PROCEDURE

Other Intervention Names

4.5mm cortical screw

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin S. Yeom

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Armed Forces Yangju Hospital

Yangju, Gyounggido, South Korea

Countries

South Korea

Other Identifiers

DR-001

Identifier Type: -

Identifier Source: org_study_id