IDE study data demonstrate significant benefits of M6-C artificial cervical disc at five years

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M6-C artificial cervical disc (Orthofix)

Patients who received the M6-C artificial cervical disc (Orthofix) continue to show statistically significant benefits compared to those who underwent anterior cervical discectomy and fusion (ACDF) at five years, according to the latest data from the M6-C artificial cervical disc single-level investigation device exemption (IDE) study.

The latest results were presented last month at the International Society for the Advancement of Spine Surgery (ISASS) annual meeting (1–4 June 2022; The Bahamas) by Frank Phillips, professor of orthopaedic surgery at Rush University Medical Center (Chicago, USA) and an investigator in the study.

“We are pleased to see that at five years postoperative, participants in the study who received the M6-C artificial cervical disc continue to show significant benefits in Neck Disability Index (NDI) scores and neck and shoulder/arm pain Visual Analogue Scale (VAS) scores compared to patients who received ACDF,” said Phillips. “Additionally, M6-C patients in the study had a low rate of revision surgery compared to the ACDF cohort. Patients in the study will be monitored out to 10 years’ postoperatively as we continue to compile the data supporting the efficacy and benefits of cervical disc arthroplasty with the M6-C disc.”

The IDE study showed that:

  • At five years, patients receiving the M6-C disc experienced a significantly better mean NDI improvement from the baseline of 47.5 points compared to 33.4 for the ACDF cohort.
  • Statistically significant favourable results were observed in shoulder/arm pain VAS scores at five-years, with a mean of 0.5 for M6-C disc study patients and 2.1 for ACDF participants. There was also a mean improvement from baseline of 6.8 for M6-C disc patients compared to 5.2 for the ACDF cohort.
  • At the five-year endpoint, the M6-C artificial cervical disc continues to demonstrate one of the lowest Subsequent Surgical Interventions (SSI) rates at 3.1 percent when compared to other FDA-approved artificial cervical discs, suggesting that these rates are consistent with data reported for other FDA approved devices.
  • Through five years’ postoperatively, five M6-C study patients experienced SSIs at the index level. Of the removals, two were performed due to persistent neck and arm pain (with one being replaced by a new M6-C disc,) and one was performed due to bone loss associated with a confirmed infection. In the ACDF cohort, 11 patients underwent SSIs during the five-year postoperative period.

Kevin Kenny, president of global spine at Orthofix, added: “We continue to be pleased with the US IDE clinical data that now includes five-year outcomes. We recognise the importance of the ongoing collection of data from the US study and implanting centres around the globe in order to expand the body of evidence that supports the clinical performance and safety of the M6-C artificial cervical disc. We look forward to continuing to disseminate and publish that data.”


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