Spineology has announced that two abstracts highlighting the company’s proprietary mesh technologies were presented during the 19th Annual Meeting of the International Society for the Advancement of Spine Surgery (ISASS; 3–5 April, Anaheim, USA).
In a poster titled “Patient-reported outcomes comparing predominant back pain or radiculopathy at baseline: 12-month trial results of a novel expandable mesh lumbar interbody grafting device,” co-authored by John Chi, (Brigham and Women’s Hospital, Boston, USA), Pierce Nunley (Spine Institute of Louisiana, Shreveport, USA), Marcus Stone (Spine Institute of Louisiana) and Faheem Sandhu (Georgetown University Hospital, Washington, USA), the authors presented results on the first 80 patients from the SCOUT IDE (Spineology Clinical Outcomes Trial) study. Patients in this study were treated with Spineology’s porous graft containment mesh, which is placed in the disc space through a small cannula and deployed as it is filled to create a conforming graft pack.
In the poster, data was evaluated for differences in clinical outcomes at the 12-month postoperative endpoint in two groups: those who presented with predominantly low back pain and those who presented with predominantly leg pain. Substantial pain and function improvements occurred early in the post-operative course for both groups and were sustained through the 12-month follow-up period. Both groups experienced similar improvements in low back pain, but improvements in leg pain and overall function, as measured by the Oswestry Disability Index (ODI), were slightly better for the group with predominantly low back pain. The predominantly back pain group also reported slightly higher satisfaction rates than the predominantly leg pain group (94% excellent or good vs. 85%). Fusion rates were high in both groups with a combined rate of 97%. No device-related serious adverse events occurred in either group.
Spineology CEO John Booth said, “The patient satisfaction scores, patient-reported clinical improvements, and fusion rates seen in this most recent data set from the SCOUT Study are very positive and will bring continued momentum toward gaining market clearance for this novel device.”
The second poster, titled “Minimally invasive transpsoas approach to lateral lumbar interbody fusion through an 18mm portal: Early multicentre study findings,“ was co-authored by John P Malloy (East Coast Orthopaedics, Pompano Beach, USA), Pierce Nunley (Spine Institute of Louisiana) and Marcus Stone (Spine Institute of Louisiana), and reports on the early clinical data from the first 50 patients enrolled in the RaDical Study, a prospective post-market study designed to evaluate outcomes in patients treated using the FDA-cleared Duo system.
Duo’s unique implant design includes PEEK, titanium and graft containment mesh elements to dramatically reduce the access required to implant the device compared to traditional lateral systems. In addition to reducing exposure requirements, the Duo implant, once filled, creates a large, load-sharing, endplate-conforming graft pack that expands up to 30mm in width to help maintain spinal correction and support fusion.
In this data set, approximately half of the subjects (51%) had their surgery at the L4–L5 level. At this reporting, 32 subjects had completed six-week post-operative exams and 24 subjects had completed three-month exams. Substantial pain and function improvements were observed and maintained throughout the analysis with median preoperative low back pain scores of 70 decreasing to 24.5 at six weeks postoperatively and 27.5 at three months. Similar median pain reductions were observed bilaterally in the lower extremity assessments with subjects reporting preoperative right and left leg pain scores of 37.5 and 48.5 compared to six-week post-operative scores of 4 and 9 and three-month scores of 4.5 and 3, respectively; this represents a reduction in pain of approximately 80%. Subjects reporting left-sided preoperative anterior thigh pain also experienced good improvement in symptoms (47 at baseline, 13 at six weeks, and 14 at three months). Low back function improvement was also reflected in ODI median score reductions from 55 at baseline to 36 and 28 at six weeks and three months, respectively. Most subjects rated their satisfaction with the procedure as excellent or good at both six weeks (91%) and three months (92%).
“Like the SCOUT Study, patient-reported clinical outcomes and satisfaction scores are extremely positive for patients treated with the Duo System in this study,” said John Booth, CEO, Spineology. “With the ability to significantly minimise retraction compared to traditional lateral systems and still place an implant that reaches up to 30mm in width once filled, we feel the Duo System offers significant advantages to surgeons and their patients.”