Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion in Circumferential Lumbar Fusion
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|ClinicalTrials.gov Identifier: NCT01513577|
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : September 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease||Other: Pedicle screws Other: Percutaneous stab incisions||Not Applicable|
To achieve lumbar fusion when there is no need for decompression of the neural structures a posterior midline approach and a left anterior retroperitoneal approach is used. The retroperitoneal anterior approach to the lumbar spine offers some benefits compared with the posterior approach. Dural injury and epidural scarring can be avoided, and an interbody fusion graft can be placed with minimal risk to the nerve roots. However, the extensive posterior midline approach with extensive muscle dissection is necessary to place the pedicular screws.
A report of a follow-up period of 2 years of a randomized trial of minimal invasive insertion of pedicular screws and rods in lumbar fusion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion Reduces Hospital Stay and Morbidity Compared to Open Midline Approach in Circumferential Lumbar Fusion. A Randomized Study With 2 Years Follow-up|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||June 2006|
|Experimental: Minimal invasive pedicular screw||
Other: Pedicle screws
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.
|Experimental: Standard open insertion||
Other: Percutaneous stab incisions
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.
- Percutaneous technique versus conventional open technique. [ Time Frame: Two years ]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.
- Improvements of recovery and convalescence. [ Time Frame: Two years ]To investigate operative time, blood loss, use of analgesic, days until ambulation without aids, hospitalization, Oswestry Disability Index.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513577
|Principal Investigator:||Sten Rasmussen, M.D.||Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark|
|Study Chair:||Henrik Kehlet, M.D.||Department of Orthopaedic Surgery, Vejle and Give Hospital|