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Direct Repair Surgery for Spondylolysis of Lumbar in Young Population

Primary Purpose

Spondylolysis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Direct repair of pars defect
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylolysis focused on measuring Spondylolysis, Lumbar spine, Young population, Direct repair, Union rate, Functional outcome

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Armed Forces Yangju Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Direct repair of pars defect

Conservative treatment

Arm Description

The pars defect was repaired with 4.5mm cortical screw.

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

Outcomes

Primary Outcome Measures

Union rate using dynamic radiographs and CT scans
union rate at postoperative 1 year was evaluated using dynamic radiographs and computed tomography (CT) scans.

Secondary Outcome Measures

Pain intensity on VAS
Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the 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.
Pain intensity on VAS
Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the 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.
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.
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.

Full Information

First Posted
April 30, 2014
Last Updated
May 2, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02129374
Brief Title
Direct Repair Surgery for Spondylolysis of Lumbar in Young Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylolysis
Keywords
Spondylolysis, Lumbar spine, Young population, Direct repair, Union rate, Functional outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct repair of pars defect
Arm Type
Experimental
Arm Description
The pars defect was repaired with 4.5mm cortical screw.
Arm Title
Conservative treatment
Arm Type
No Intervention
Arm Description
The pars defect of spondylolysis was not repaired with cortical screw.
Intervention Type
Procedure
Intervention Name(s)
Direct repair of pars defect
Other Intervention Name(s)
4.5mm cortical screw
Intervention Description
Direct repair at pars defect was performed with 4.5mm cortical screw in young spondylolytic patients.
Primary Outcome Measure Information:
Title
Union rate using dynamic radiographs and CT scans
Description
union rate at postoperative 1 year was evaluated using dynamic radiographs and computed tomography (CT) scans.
Time Frame
Postoperative 1 year
Secondary Outcome Measure Information:
Title
Pain intensity on VAS
Description
Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.
Time Frame
postoperative 3 months
Title
Pain intensity on VAS
Description
Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.
Time Frame
postoperative 6 months
Title
Pain intensity on VAS
Description
Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.
Time Frame
postoperative 12 months
Title
Functional outcome on ODI and SF-12
Description
Functional outcome using oswestry disability index (ODI) and 12-item short form health survey (SF-12) was evaluated separately at the postoperative 3 months.
Time Frame
Postoperative 3 months
Title
Functional outcome on ODI and SF-12
Description
Functional outcome using oswestry disability index (ODI) and 12-item short form health survey (SF-12) was evaluated separately at the postoperative 3 months.
Time Frame
Postoperative 6 months
Title
Functional outcome on ODI and SF-12
Description
Functional outcome using oswestry disability index (ODI) and 12-item short form health survey (SF-12) was evaluated separately at the postoperative 3 months.
Time Frame
Postoperative 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Armed Forces Yangju Hospital
City
Yangju
State/Province
Gyounggido
Country
Korea, Republic of

12. IPD Sharing Statement

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Direct Repair Surgery for Spondylolysis of Lumbar in Young Population

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