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Completed

NCT Number: NCT02129374

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.

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Key information

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armed Forces Yangju Hospital

Yangju, Gyounggido, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct repair of pars defect

Procedure

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

Other names: 4.5mm cortical screw

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 2, 2014
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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