An interventional study of Posterolateral lumbar fusion surgery in Trauma, sponsored by Northern Orthopaedic Division, Denmark. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-15.
Sponsored by Northern Orthopaedic Division, Denmark · Not applicable, Interventional, and Treatment
Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. The aim of this study is to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (MD).
Posterior approach is a common and important surgical procedure for various lumbar diseases. Owing to the anatomy, the damage of paraspinal muscle is inevitable during conventional posterior lumbar fusion surgery. Degeneration and malfunction of the paraspinal muscle might associate with pain and inferior postoperative clinical outcome.
Northern Orthopaedic Division, Denmark is the lead sponsor of 61 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Eight healthy volunteers (five males and three females) with a body mass index of 23.8 and without chronic metabolic disease or low back pain. They are all non-smokers and non-medicated.
Procedure: Posterolateral lumbar fusion surgery
Two MD catheters is placed in the paraspinal muscle at the level of midpoint of incision bilaterally. A reference catheter is placed in the deltoid muscle.
Procedure: Posterolateral lumbar fusion surgery
Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.
Also known as: Lumbar diseases
The glycerol concentration
To study whether the glucerol concentration can be used to evaluate surgery related paraspinal muscle damage
Time frame: Two hours
No study locations are listed for this record.
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Northern Orthopaedic Division, Denmark