Orthofix Announces First Presentation of Seven-Year Outcome Data for the M6-C Artificial Cervical Disc With Other Clinical and Scientific Abstracts at the ISASS Annual Meeting

LEWISVILLE, Texas, June 1, 2023 /OrthoSpineNews/ – Orthofix Medical Inc. (NASDAQ:OFIX), a number one world spine and orthopedics firm, right this moment introduced the presentation of a number of medical and scientific abstracts through the Worldwide Society for the Development of Backbone Surgical procedure (ISASS) annual assembly in San Francisco June 1-3, 2023.

“We’re happy to assist a variety of abstracts and medical information through the annual ISASS assembly, together with the primary presentation of the seven-year information from the M6-C synthetic cervical disc U.S. IDE research,” stated Kevin Kenny, President of World Backbone. “ISASS is a vital alternative for attendees to study from a distinguished surgeon panel that may present their insights about cervical disc substitute and long-term outcomes of this remedy. Moreover, we’re proud to assist presentation of information for our Bone Progress Remedy and Biologic options.”

On the ISASS annual assembly, Orthofix is presenting a wide range of business abstracts and posters centered on the corporate’s M6-C^™ synthetic cervical disc, CervicalStim^™ bone progress stimulator and Trinity Elite^™ Allograft with viable cells.

Movement Preservation

“M6-C Synthetic Cervical Disc: Seven-Yr Outcomes for Single-Degree Whole Disc Alternative with a Novel Viscoelastic Synthetic Cervical Disc” – summary presentation by Dr. Todd Lanman.

This summary is the primary public presentation of particular seven-year medical outcomes related to using the M6-C synthetic cervical disc for the therapy of single-level symptomatic cervical radiculopathy. The presentation will likely be on Saturday, June 3 at 10:00 a.m. in Salons 10-12 by Dr. Todd Lanman. Highlighted outcomes embody:

Decreases in incapacity as measured by NDI and reduces in Neck and Arm Ache Scores that had been noticed at prior follow-up intervals and had been retained by means of seven-years post-op
Eleven Secondary Surgical Interventions (SSI) had been noticed among the many M6-C disc cohort (6.9%). This charge is akin to seven-year SSI charges reported for different commercially accessible synthetic cervical discs
Annual follow-up of this cohort will proceed by means of 10-years post-op

“Cervical Disc Arthroplasty Skilled Panel: Osteolysis and Periprosthetic Bone Adjustments in Cervical Disc Alternative” – tutorial programsession with moderator Dr. Gunnar Andersson and audio system Dr. Josh Jacobs, Dr. Armen Khachatryan, Dr. Todd Lanman, Dr. Steven Kurtz and Dr. Sophia Sangiorgio.

This multidisciplinary panel of clinicians and researchers will focus on the evaluation of bone adjustments round synthetic cervical disc implants, leveraging prior analysis in hip and knee arthroplasty. Panel will likely be performed on Friday, June 2 at 1:20 p.m. in Salons 10-12. Subjects coated embody:

Categorization and classification of radiographic observations
Medical administration of noticed bone adjustments post-cervical disc substitute

“Proposed Classification System of Radiographic Bony Adjustments after Cervical Disc Alternative” – poster by Dr. Armen Khachatryan.

Poster will likely be positioned within the Exhibit Corridor. Content material highlights embody:

Introduction of classification system for post-cervical disc substitute radiographic observations
Evaluation of system reliability

Bone Progress Remedy

“CervicalStim Bone Progress Remedy: Electrical Stimulation Used as an Adjunct to Cervical Backbone Fusion in Sufferers at Danger for Pseudarthrosis” – podium presentation with Dr. Ilyas Aleem.

This presentation will cowl the outcomes of a potential multicenter research that evaluated the adjunct impact of PEMF in topics present process cervical spinal surgical procedure who introduced with danger components for pseudarthrosis (multilevel fusion, prior failed cervical spine fusion, diabetes, osteoporosis, or nicotine use). Presentation will likely be performed on Saturday June 3, at 10:32 a.m. in Salons 13-15. Highlights embody:

Out of 160 topics, 144 (90.0%) had been graded as fused (all ranges) on the 12-month go to
Fusion success was 91.7% (n=55/60) for topics with a single danger issue, 89.0% (n=89/100) for topics with two or extra danger components, and 90.9% (n=20/22) for topics with three or extra danger components
Important enhancements in NDI, VAS (arm and neck), SF-36, and EQ-5D had been noticed in comparison with baseline scores (p<0.001)

“CervicalStim Bone Progress Remedy: Adjunctive Use of Bone Progress Stimulation in Cervical Backbone Fusion in Sufferers at Danger for Pseudarthrosis” – poster by Dr. Ilyas Aleem.

Poster highlights outcomes of a research that evaluated cervical spine fusion charges for topics with a number of danger components for pseudarthrosis; topics that acquired PEMF therapy had been in comparison with matched topics that didn’t obtain PEMF therapy. Poster will likely be positioned within the Exhibit Corridor. Outcomes embody:

At 12 months post-op, topics within the PEMF handled group (n=161) had a 90.1% fusion charge, in comparison with a 65.4% fusion charge for the management group (n=26) (p<0.001)
Topics within the PEMF handled group had a considerably increased variety of danger components for nonunion (1.8 for handled group vs. 1.1 for management, p<0.001), and considerably increased variety of surgical ranges (2.8 for handled group vs. 2.0 for management, p<0.005)
When in comparison with management topics that didn’t use PEMF stimulation, handled topics had improved fusion outcomes regardless of being older, having extra danger components for pseudarthrosis, and present process extra advanced surgical procedures

Biologics

“Trinity Elite Allograft: Radiographic and Medical Outcomes in Topics that Underwent Single-Degree or Multilevel Anterior, Posterior or Lateral Lumbar Interbody Fusion with a Mobile Bone Allograft” – podium presentation by Dr. Pierce Nunley on behalf of Dr. Todd Lansford.

This research investigates the effectiveness of mobile bone allograft in lumbar spinal fusion by surgical strategy (e.g., anterior, lateral, and posterior). Presentation of information will likely be on Saturday, June 3 at 10:30 a.m. in Salons 13-15. Highlights embody:

Evaluation of 252 topics handled by way of anterior, lateral, or posterior approaches reported fusion success by bridging bone evaluation, in addition to bridging bone and Quantitative Movement Evaluation (QMA) evaluation, at time of research closure.
At 12 months, the general fusion success charge for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. Fusion success for bridging bone and QMA evaluation was 83%, 94.6%, and 93.8% for anterior, lateral, and posterior approaches, respectively.
At 24 months, the general fusion success charge for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. Fusion success for bridging bone and QMA evaluation was 85.4%, 96.1%, and 92.9% for anterior, lateral, and posterior approaches, respectively.
Important enhancements in quality-of-life, ache, and incapacity scores had been additionally famous, no matter the surgical strategy.

“Trinity Elite Allograft: Twenty-4-Month Interim Outcomes from a Potential Medical Trial Evaluating the Efficiency and Security of Mobile Bone Allograft in Sufferers Present process Lumbar Spinal Fusion” – podium presentation by Dr. Daniel Park.

This summary stories on the result measures from a potential, multicenter heart medical research that assessed the efficacy and security of mobile bone allograft when used as an adjunct to lumbar arthrodesis out to 24-months follow-up. This information will likely be introduced on Friday, June 2 at 11:02 a.m. in Salons 10-12. Highlights embody:

On the time of interim evaluation, 86 topics reported information mandatory to judge each fusion and incapacity by means of 24-months postoperative
Fusion charge, primarily based on bridging bone evaluation and QMA, was reported to be 95.3% (N=86)
ODI and VAS Leg and VAS Again Ache scores all reported vital enhancements from baseline (p<0.001)

To study extra in regards to the full portfolio of Orthofix options, please go to us at sales space #100 on the ISASS assembly.

About Orthofix

The newly merged Orthofix-SeaSpine group is a number one world spine and orthopedics firm with a complete portfolio of biologics, modern spinal {hardware}, bone progress therapies, specialised orthopedic options and a number one surgical navigation system. Its merchandise are distributed in roughly 68 nations worldwide.

The Firm is headquartered in Lewisville, Texas and has main places of work in Carlsbad, CA, with a deal with spine and biologics product innovation and surgeon training, and Verona, Italy, with an emphasis on product innovation, manufacturing, and medical training for orthopedics. The mixed firm’s world R&D, business and manufacturing footprint additionally contains services and places of work in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Department, MS, Maidenhead, UK, Munich, Germany, Paris, France and São Paulo, Brazil.