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Direct Repair Surgery for Spondylolysis of Lumbar in Young Population

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ClinicalTrials.gov Identifier: NCT02129374
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
Jin S. Yeom, Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Spondylolysis Procedure: Direct repair of pars defect Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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 Name: 4.5mm cortical screw

No Intervention: Conservative treatment
The pars defect of spondylolysis was not repaired with cortical screw.



Primary Outcome Measures :
  1. Union rate using dynamic radiographs and CT scans [ Time Frame: Postoperative 1 year ]
    union rate at postoperative 1 year was evaluated using dynamic radiographs and computed tomography (CT) scans.


Secondary Outcome Measures :
  1. Pain intensity on VAS [ Time Frame: postoperative 3 months ]
    Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.

  2. Pain intensity on VAS [ Time Frame: postoperative 6 months ]
    Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.

  3. Pain intensity on VAS [ Time Frame: postoperative 12 months ]
    Pain intensity on lower back was evaluated with 10-point visual analogue scale (VAS) at the postoperative 6 months.

  4. Functional outcome on ODI and SF-12 [ Time Frame: Postoperative 3 months ]
    Functional outcome using oswestry disability index (ODI) and 12-item short form health survey (SF-12) was evaluated separately at the postoperative 3 months.

  5. Functional outcome on ODI and SF-12 [ Time Frame: Postoperative 6 months ]
    Functional outcome using oswestry disability index (ODI) and 12-item short form health survey (SF-12) was evaluated separately at the postoperative 3 months.

  6. Functional outcome on ODI and SF-12 [ Time Frame: Postoperative 12 months ]
    Functional outcome using oswestry disability index (ODI) and 12-item short form health survey (SF-12) was evaluated separately at the postoperative 3 months.



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129374


Locations
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Korea, Republic of
Armed Forces Yangju Hospital
Yangju, Gyounggido, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Jin S. Yeom, Associated Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02129374     History of Changes
Other Study ID Numbers: DR-001
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by Jin S. Yeom, Seoul National University Hospital:
Spondylolysis
Lumbar spine
Young population
Direct repair
Union rate
Functional outcome

Additional relevant MeSH terms:
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Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases