NCT01513577|Completed
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Sponsor study identifier
interventional
16
0 countries
N/A
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2004
Actual (reported)Study Completion
June 2006
Actual (reported)Convalescence after lumbar surgery is dependent on the extensiveness of the surgical procedure. Minimal invasive techniques in lumbar spine surgery are reported to achieve excellent clinical results with less pain, morbidity and disability.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2006
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
December 2004
Actual (reported)June 2006
Actual (reported)December 14, 2011
Actual (reported)January 20, 2012
Actual (reported)Percutaneous technique versus conventional open technique.
The investigators want to assess the effects of percutaneous posterior technique versus conventional open posterior technique on post-fusion pain, mobilization, convalescence, disability and bony fusion in 360 degree lumbar fusion.
Two years
Improvements of recovery and convalescence.
Two years
The control group received posterior fixation with pedicle screws through a midline approach. Through the approach bone was harvested from the right posterior iliac crest. Before closure of the posterior approach an epidural catheter and a drain was placed.
The intervention group received posterior fixation through 6 percutaneous stab incisions with the use of the sextant system. Through a separate 3-4 cm long incision, bone was harvested from the right posterior iliac crest. After decorticating the transverse processes through the stab wounds, the bone graft was placed with a 10 ml cut syringe. An epidural catheter was placed at the end of the posterior procedure.
Sten Rasmussen, M.D.
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Henrik Kehlet, M.D.
Department of Orthopaedic Surgery, Vejle and Give Hospital
16 participants (actual enrollment reported by the registry).
First Submitted
December 14, 2011
First Posted
January 20, 2012
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2004
Actual (reported)Study Completion
June 2006
Actual (reported)Last Updated
September 15, 2014
Record last verified: 2014-09
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Source: ClinicalTrials.gov.
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