Sam Brusco, Associate Editor12.21.23
Orthofix has published new data from a study investigating Pulsed Electromagnetic Field (PEMF) stimulation as an adjunct therapy to lumbar spinal fusion in those at risk for pseudoarthrosis.
The company said, based on the study published in the International Journal of Spine Surgery, that treatment with its SpinalStim bone growth therapy device “demonstrated a high rate of successful fusion with significant improvements in pain, function and quality of life, despite having risk factors for pseudarthrosis.”
“Patients with risk factors such as a prior failed fusion, the need for a multilevel fusion, nicotine use, osteoporosis or diabetes often have a difficult time healing after lumbar fusion surgery,” said lead author Dr. Marc Weinstein, an orthopedic spine surgeon at the Florida Orthopaedic Institute in Tampa, Florida. “These risk factors contribute to complications and pseudarthrosis, which can prolong pain and ultimately reduce quality of life. This data reinforces the use of PEMF stimulation after lumbar fusion surgery to improve outcomes regardless of the patients’ risk factors.”
142 patients were enrolled and assigned in-home SpinalStim use for six months after spinal fusion. Successful fusion for patients with one, two or three or more risk factors was 88.5%, 87.5%, and 82.3% respectively. Patient reported outcomes measuring disability, function, pain, quality of life, and overall well-being were also evaluated with “significant improvements.”
“The SpinalStim bone growth therapy device provides a noninvasive and cost-effective means to augment spinal fusion procedures that enables the patient to continue their healing at home,” said Kevin Kenny, president of Orthofix Global Spine. “This new data is important as it adds to the body of evidence supporting the use of PEMF for high-risk patients who face challenges with bone fusion healing.”
The company said, based on the study published in the International Journal of Spine Surgery, that treatment with its SpinalStim bone growth therapy device “demonstrated a high rate of successful fusion with significant improvements in pain, function and quality of life, despite having risk factors for pseudarthrosis.”
“Patients with risk factors such as a prior failed fusion, the need for a multilevel fusion, nicotine use, osteoporosis or diabetes often have a difficult time healing after lumbar fusion surgery,” said lead author Dr. Marc Weinstein, an orthopedic spine surgeon at the Florida Orthopaedic Institute in Tampa, Florida. “These risk factors contribute to complications and pseudarthrosis, which can prolong pain and ultimately reduce quality of life. This data reinforces the use of PEMF stimulation after lumbar fusion surgery to improve outcomes regardless of the patients’ risk factors.”
142 patients were enrolled and assigned in-home SpinalStim use for six months after spinal fusion. Successful fusion for patients with one, two or three or more risk factors was 88.5%, 87.5%, and 82.3% respectively. Patient reported outcomes measuring disability, function, pain, quality of life, and overall well-being were also evaluated with “significant improvements.”
“The SpinalStim bone growth therapy device provides a noninvasive and cost-effective means to augment spinal fusion procedures that enables the patient to continue their healing at home,” said Kevin Kenny, president of Orthofix Global Spine. “This new data is important as it adds to the body of evidence supporting the use of PEMF for high-risk patients who face challenges with bone fusion healing.”