Direct Repair Surgery for Spondylolysis of Lumbar in Young Population

NCT02129374 | Completed

• 1 other identifier: DR-001
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Pain intensity on VAS

  postoperative 3 months

• Pain intensity on VAS

  postoperative 6 months

• Pain intensity on VAS

  postoperative 12 months

• Functional outcome on ODI and SF-12

  Postoperative 3 months

• Functional outcome on ODI and SF-12

  Postoperative 6 months

Study Arms (2)

Direct repair of pars defect

EXPERIMENTAL

The pars defect was repaired with 4.5mm cortical screw.

Procedure: Direct repair of pars defect

Conservative treatment

NO INTERVENTION

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

Interventions

Direct repair of pars defect PROCEDURE

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

Also known as: 4.5mm cortical screw

Direct repair of pars defect

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Armed Forces Yangju Hospital

Yangju, Gyounggido, South Korea

Location

MeSH Terms

Conditions

Spondylolysis

Condition Hierarchy (Ancestors)

Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 2, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

KR (1)