Mark Kurd, MD, orthopaedic surgeon on the medical staff at Bryn Mawr Hospital, part of Main Line Health, treated the first patient using the Innovative Surgical Designs, Inc., Altum® Pedicle Osteotomy System. The patient was treated through a randomized clinical trial that compares the safety and effectiveness of the Altum® implant to transforaminal lumbar interbody fusion (TLIF) in patients with symptomatic, one or two level lumbar spinal stenosis (LSS) and one level grade I degenerative spondylolisthesis requiring surgical treatment.
“We are thrilled to be participating in the clinical evaluation of this new minimally invasive treatment option for patients with lumbar spinal stenosis and degenerative spondylolisthesis,” says Dr. Kurd, who serves as the study’s principal investigator. “As a leader of orthopaedic care in the region, Bryn Mawr Hospital is honored to have had the first patient treated using this innovative system.”
The Altum® Pedicle Osteotomy System contains the implants and instruments required to perform the pedicle lengthening osteotomy procedure for the treatment of lumbar spinal stenosis in the setting of degenerative spondylolisthesis. The Altum® implant is an expandable bone screw that is available in a variety of sizes (7.5 mm, 8.5 mm and 9.5 mm). Altum® instruments and implants come in a single-use disposable kit.
“We are excited and hopeful that we will be able to prove the safety and effectiveness of this new device for the treatment of patients with lumbar spinal stenosis and spondylolisthesis,” said Jonathan Rinehart, general counsel, Innovative Surgical Designs, Inc. “I have personally been very surprised at how receptive patients have been during the recruitment process. If the trial proves successful it may carve out a new market in spine for those patients who are currently delaying surgery.”
The trial is a multi-center study that will enroll 344 subjects between the ages of 40 and 80. Those who meet all eligibility criteria consent to receive randomization into either one of the following: transforaminal lumbar interbody fusion (TLIF) treatment cohort or the Altum® pedicle osteotomy treatment cohort. Following treatment, subjects are observed and evaluated for a two year period.
For more information on the trial, please visit clinicaltrials.gov/ct2/show/NCT03381677. For information about Orthopaedic Services at Main Line Health, visit mainlinehealth.org/specialties/orthopaedic-surgery.
Please note: In full disclosure, Dr. Kurd’s surgical practice partner is a stakeholder at Innovative Surgical Designs, Inc., the developers of the Altum® Pedicle Osteotomy System. Dr. Kurd does not have any personal financial interest in the technology.