Advice

Summary

Summary

Mobi‑C is a prosthetic device used for 1‑ or 2‑level cervical disc replacement. It is designed for people with cervical disc degeneration. The evidence from 1 systematic review and 3 additional studies summarised in this briefing includes 1,675 individual patients and is of mixed quality. The systematic review concluded that Mobi‑C is non‑inferior to anterior cervical discectomy and fusion (ACDF). The studies found that Mobi‑C (at 1 or 2 levels) was more effective than ACDF for overall success and for reducing limitations of daily activity as a result of neck pain, and allowed a greater range of motion with less adjacent‑segment degeneration and less need for subsequent surgery. Each Mobi‑C prosthesis costs £1,750 (excluding VAT).

Product summary and likely place in therapy

  • Mobi‑C is a prosthetic device designed for 1- or 2‑level cervical intervertebral total disc replacement for people with cervical disc degeneration.

  • It is an alternative to conservative treatment options (such as rest, analgesic medication, physical therapy and local corticosteroid injections) or to anterior cervical discectomy and fusion (ACDF), and alternative disc replacement systems.

Effectiveness and safety

  • The published evidence summarised in this briefing comes from 1 systematic review and 3 randomised controlled trials of mixed quality. None of the studies were done in the UK. All 3 trials used ACDF as a comparator.

  • In the systematic review which included 1,319 patients, 1‑level Mobi‑C was found to be non‑inferior to ACDF, but had high rates of heterotopic ossification (bone formation in soft tissue).

  • In 1 randomised controlled trial of 2‑level Mobi‑C included in the systematic review (n=330), the subsequent 4‑year follow‑up found that 66% of the Mobi‑C group and 36% of the ACDF group achieved a composite end point of overall success.

  • A similar trial of 1‑level Mobi‑C (n=245) found that at 5 years, the composite overall success was 61.9% with Mobi‑C and 52.2% with ACDF (statistically non‑inferior).

  • Another randomised controlled trial of 1‑level Mobi‑C (n=111) found a statistically significantly greater range of motion with Mobi‑C than ACDF. None of the patients who had Mobi‑C needed adjacent‑segment reoperations compared with 7.1% of those having ACDF at 4 years.

Technical and patient factors

  • The manufacturer states that Mobi‑C may be used if a person's cervical disc degeneration has not responded to at least 6 weeks of conservative treatment, or if they have shown progressive signs or symptoms despite non‑operative treatment.

  • The prosthetic disc is delivered pre‑assembled on a disposable cartridge, which allows the position of the prosthesis to be checked using X‑rays.

  • The device is suitable for skeletally mature adults. Treatment should be carried out by spinal surgeons in specialist centres.

Cost and resource use

  • A single Mobi‑C prosthesis costs £1,750 (excluding VAT). Two Mobi‑C devices are needed for 2‑level cervical disc replacement.

  • A US cost‑effectiveness analysis found that the average cost per patient in the 5 years after surgery was $23,459 (about £16,515) for Mobi‑C, and $21,772 (about £16,031) for ACDF. The incremental cost‑effectiveness ratio was $8,518 (about £6,000) per quality‑adjusted life year in favour of Mobi‑C.