Direct Repair Surgery for Spondylolysis of Lumbar in Young Population

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 Overview

• Status: Completed
• Conditions: Spondylolysis
• Intervention / Treatment: Procedure: Direct repair of pars defect

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyounggido
    • Yangju, Gyounggido, Korea, Republic of
      • Armed Forces Yangju Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Direct repair of pars defect; The pars defect was repaired with 4.5mm cortical screw.	Procedure: Direct repair of pars defect; Direct repair at pars defect was performed with 4.5mm cortical screw in young spondylolytic patients.; Other Names: 4.5mm cortical screw
NO_INTERVENTION: Conservative treatment; The pars defect of spondylolysis was not repaired with cortical screw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (ESTIMATE): May 2, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 2, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Lumbar spine; Functional outcome; Spondylolysis; Young population; Direct repair; Union rate
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylosis; Spondylolysis
• Other Study ID Numbers: DR-001