Michael Barbella, Managing Editor06.01.23
Orthofix Medical Inc. is presenting multiple clinical and scientific abstracts over the next three days during the International Society for the Advancement of Spine Surgery (ISASS) annual meeting in San Francisco (June 1-3).
“We are pleased to support a wide range of abstracts and clinical data during the annual ISASS meeting, including the first presentation of the seven-year data from the M6-C artificial cervical disc U.S. IDE study,” Global Spine President Kevin Kenny said. “ISASS is an important opportunity for attendees to learn from a distinguished surgeon panel that will provide their insights about cervical disc replacement and long-term outcomes of this therapy. Additionally, we are proud to support presentation of data for our Bone Growth Therapy and Biologic solutions.”
At the ISASS annual meeting, Orthofix is presenting seven industry abstracts and posters focused on the company’s M6-C artificial cervical disc, CervicalStim bone growth stimulator, and Trinity Elite Allograft with viable cells.
Motion Preservation
“M6-C Artificial Cervical Disc: Seven-Year Outcomes for Single-Level Total Disc Replacement with a Novel Viscoelastic Artificial Cervical Disc” — abstract presentation by Dr. Todd Lanman. This abstract is the first public presentation of specific seven-year clinical results associated with the use of the M6-C artificial cervical disc for the treatment of single-level symptomatic cervical radiculopathy. The presentation is scheduled for June 3 at 10:00 a.m. Highlighted results include:
“Proposed Classification System of Radiographic Bony Changes after Cervical Disc Replacement” — poster by Dr. Armen Khachatryan. Poster will be located in the Exhibit Hall. Content highlights include the introduction of a classification system for post-cervical disc replacement radiographic observations, and an analysis of system reliability.
Bone Growth Therapy
“CervicalStim Bone Growth Therapy: Electrical Stimulation Used as an Adjunct to Cervical Spine Fusion in Patients at Risk for Pseudarthrosis” — podium presentation with Dr. Ilyas Aleem. This presentation will cover the results of a prospective multicenter study that evaluated the adjunct effect of PEMF in subjects undergoing cervical spinal surgery who presented with risk factors for pseudarthrosis (multilevel fusion, prior failed cervical spine fusion, diabetes, osteoporosis, or nicotine use). The presentation will take place on June 3 at 10:32 a.m. Highlights include:
Biologics
“Trinity Elite Allograft: Radiographic and Clinical Outcomes in Subjects that Underwent Single-Level or Multilevel Anterior, Posterior or Lateral Lumbar Interbody Fusion with a Cellular Bone Allograft” — podium presentation by Dr. Pierce Nunley on behalf of Dr. Todd Lansford. This study investigates the effectiveness of cellular bone allograft in lumbar spinal fusion by surgical approach (e.g., anterior, lateral, and posterior). Presentation will be on June 3 at 10:30 a.m. Highlights include:
The newly merged Orthofix-SeaSpine organization is a lglobal spine and orthopedics company with a portfolio of biologics, spinal hardware, bone growth therapies, specialized orthopedic solutions, and a surgical navigation system. Its products are distributed in approximately 68 countries worldwide. The company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, Calif., with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics. The combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, Calif.; Toronto, Canada; Sunnyvale, Calif.; Wayne, Pa.; Olive Branch, Miss.; Maidenhead, U.K.; Munich, Germany; Paris, France; and São Paulo, Brazil.
“We are pleased to support a wide range of abstracts and clinical data during the annual ISASS meeting, including the first presentation of the seven-year data from the M6-C artificial cervical disc U.S. IDE study,” Global Spine President Kevin Kenny said. “ISASS is an important opportunity for attendees to learn from a distinguished surgeon panel that will provide their insights about cervical disc replacement and long-term outcomes of this therapy. Additionally, we are proud to support presentation of data for our Bone Growth Therapy and Biologic solutions.”
At the ISASS annual meeting, Orthofix is presenting seven industry abstracts and posters focused on the company’s M6-C artificial cervical disc, CervicalStim bone growth stimulator, and Trinity Elite Allograft with viable cells.
Motion Preservation
“M6-C Artificial Cervical Disc: Seven-Year Outcomes for Single-Level Total Disc Replacement with a Novel Viscoelastic Artificial Cervical Disc” — abstract presentation by Dr. Todd Lanman. This abstract is the first public presentation of specific seven-year clinical results associated with the use of the M6-C artificial cervical disc for the treatment of single-level symptomatic cervical radiculopathy. The presentation is scheduled for June 3 at 10:00 a.m. Highlighted results include:
- Decreases in disability as measured by NDI and decreases in Neck and Arm Pain Scores that were observed at prior follow-up periods and were retained through seven-years post-op
- Eleven Secondary Surgical Interventions (SSI) were observed among the M6-C disc cohort (6.9%). This rate is comparable to seven-year SSI rates reported for other commercially available artificial cervical discs
- Annual follow-up of this cohort will continue through 10-years post-op
“Proposed Classification System of Radiographic Bony Changes after Cervical Disc Replacement” — poster by Dr. Armen Khachatryan. Poster will be located in the Exhibit Hall. Content highlights include the introduction of a classification system for post-cervical disc replacement radiographic observations, and an analysis of system reliability.
Bone Growth Therapy
“CervicalStim Bone Growth Therapy: Electrical Stimulation Used as an Adjunct to Cervical Spine Fusion in Patients at Risk for Pseudarthrosis” — podium presentation with Dr. Ilyas Aleem. This presentation will cover the results of a prospective multicenter study that evaluated the adjunct effect of PEMF in subjects undergoing cervical spinal surgery who presented with risk factors for pseudarthrosis (multilevel fusion, prior failed cervical spine fusion, diabetes, osteoporosis, or nicotine use). The presentation will take place on June 3 at 10:32 a.m. Highlights include:
- Of 160 subjects, 144 (90.0%) were graded as fused (all levels) at the 12-month visit
- Fusion success was 91.7% (n=55/60) for subjects with a single risk factor, 89% (n=89/100) for subjects with two or more risk factors, and 90.9% (n=20/22) for subjects with three or more risk factors
- Significant improvements in NDI, VAS (arm and neck), SF-36, and EQ-5D were observed compared to baseline scores (p<0.001)
- At 12 months post-op, subjects in the PEMF treated group (n=161) had a 90.1% fusion rate, compared to a 65.4% fusion rate for the control group (n=26) (p<0.001)
- Subjects in the PEMF treated group had a significantly higher number of risk factors for nonunion (1.8 for treated group vs. 1.1 for control, p<0.001), and significantly higher number of surgical levels (2.8 for treated group vs. 2.0 for control, p<0.005)
- When compared to control subjects that did not use PEMF stimulation, treated subjects had improved fusion outcomes despite being older, having more risk factors for pseudarthrosis, and undergoing more complex surgeries
Biologics
“Trinity Elite Allograft: Radiographic and Clinical Outcomes in Subjects that Underwent Single-Level or Multilevel Anterior, Posterior or Lateral Lumbar Interbody Fusion with a Cellular Bone Allograft” — podium presentation by Dr. Pierce Nunley on behalf of Dr. Todd Lansford. This study investigates the effectiveness of cellular bone allograft in lumbar spinal fusion by surgical approach (e.g., anterior, lateral, and posterior). Presentation will be on June 3 at 10:30 a.m. Highlights include:
- Analysis of 252 subjects treated via anterior, lateral, or posterior approaches reported fusion success by bridging bone assessment, as well as bridging bone and Quantitative Motion Analysis (QMA) assessment, at time of study closure.
- At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100%, and 97.9% for anterior, lateral, and posterior approaches, respectively. Fusion success for bridging bone and QMA assessment was 83%, 94.6%, and 93.8% for anterior, lateral, and posterior approaches, respectively.
- At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100%, and 98.8% for anterior, lateral, and posterior approaches, respectively. Fusion success for bridging bone and QMA assessment was 85.4%, 96.1%, and 92.9% for anterior, lateral, and posterior approaches, respectively.
- Significant improvements in quality-of-life, pain, and disability scores were also noted, irrespective of the surgical approach.
- At the time of interim analysis, 86 subjects reported data necessary to evaluate both fusion and disability through 24-months postoperative
- Fusion rate, based on bridging bone assessment and QMA, was reported to be 95.3% (N=86)
- ODI and VAS Leg and VAS Back Pain scores all reported significant improvements from baseline (p<0.001)
The newly merged Orthofix-SeaSpine organization is a lglobal spine and orthopedics company with a portfolio of biologics, spinal hardware, bone growth therapies, specialized orthopedic solutions, and a surgical navigation system. Its products are distributed in approximately 68 countries worldwide. The company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, Calif., with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics. The combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, Calif.; Toronto, Canada; Sunnyvale, Calif.; Wayne, Pa.; Olive Branch, Miss.; Maidenhead, U.K.; Munich, Germany; Paris, France; and São Paulo, Brazil.