A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis

Hannah Webb, Mercer University College of Pharmacy

 

Lumbar spinal stenosis is caused by a gradual narrowing of the spinal canal. Patients with lumbar spinal stenosis typically present with low back pain and leg pain that worsens with walking.

 

Until now, the efficacy of fusion surgery in addition to decompression surgery in patients who have lumbar spinal stenosis, with or without degenerative spondylolisthesis, has not been substantiated in controlled trials. [1]

Title: A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis
Design Multicenter, open-label, randomized control trial; N= 233
Objective To investigate whether fusion surgery as an adjunct to decompression surgery resulted in better clinical outcomes at 2 years than decompression surgery alone among patients who underwent surgery for lumbar spinal stenosis, with or without preoperative degenerative spondylolisthesis
Study Groups Absence of degenerative spondylolisthesis (n= 98); presence of degenerative spondylolisthesis (n= 135)
Methods Patients between 50 and 80 years of age who had received a diagnosis of lumbar spinal stenosis and who met the inclusion criteria were randomized in a 1:1 ratio to undergo either decompression surgery plus fusion surgery or decompression surgery alone.
Duration Two years
Primary Outcome Measure Oswestry Disability Index (ODI) score
Baseline Characteristics Characteristics Absence of Degenerative Spondylolisthesis Presence of Degenerative Spondylolisthesis
  Fusion Decompression alone Fusion Decompression alone
Mean age 66 66 68 67
Female 41% 56% 76% 82%
Smoker 15% 17% 13% 15%
ODI score 43 41 41 41
Results   Absence of Degenerative Spondylolisthesis Presence of Degenerative Spondylolisthesis
Fusion Group Decompression Alone Group Fusion Group Decompression Alone Group
At 2 years
ODI score 29 27 25 21
p value 0.70 0.70 0.11 0.11
Adverse Events Common Adverse Events: dural tear (11%), postoperative wound infection that required antibiotic treatment (10%), myocardial infarction (1%), stroke (1%), and thromboembolic events (1%)
Serious Adverse Events: N/A
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions No clinical benefit was seen 2 years after surgery from adding fusion surgery to decompression surgery.

This multicenter, open label randomized controlled trial showed that those who underwent lumbar spinal stenosis did not result in clinical outcomes that were superior to those that underwent decompression surgery alone. Hospital costs increased with the addition of fusion surgery, including the cost of additional surgery, added in-hospital stay time, and risk of hospital-acquired infections. The increased risks and costs associated with the addition of decompression surgery after spinal stenosis surgery should be considered before deciding on this surgery.

References

Forsth, Peter, Gylfi Olafsson, Thomas Carlsson, Anders Frost, Fedrik Borgstrom, Peter Fritzell, Patrik Ohagen, Karl Michaelsson, and Bengt Sanden. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. The New England Journal of Medicine. Vol. 374 No. 15.

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