NICE has recently provided guidance on approval for Actifit meniscal reconstruction as given below.
Mr Spalding published A research paper on Actifit in 2011 which formed part of the basis of the NICE review.
All patients undergoing Actifit implantation are prospectively evaluated, by invitation to complete outcome evaluation scores, Pre-op and at 1,2 and 5 years. Patients are recommended to undergo MRI evaluation at 12 months.
Mr Spalding is therefore fully compliant with the NICE guidelines.
Excerpt from NICE guidelines July 2012
1.1 Current evidence on partial replacement of the meniscus of the knee using a biodegradable scaffold raises no major safety concerns. Evidence for any advantage of the procedure over standard surgery, for symptom relief in the short term, or for any reduction in further operations in the long term, is limited in quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake partial replacement of the meniscus of the knee using a biodegradable scaffold should take the following actions.
• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand that there are uncertainties about any possible long-term advantage over other surgical options and that considerable rehabilitation is required after this procedure. Clinicians should provide patients with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended.
• Audit and review clinical outcomes of all patients having partial replacement of the meniscus of the knee using a biodegradable scaffold.
1.3 The procedure should only be carried out by surgeons who are highly experienced in arthroscopic meniscal surgery.
1.4 NICE encourages further research and data collection on partial replacement of the meniscus of the knee using a biodegradable scaffold. This should include clear descriptions of patient selection and adjunctive treatments. Outcome measures should include symptom relief and functional ability in the short term and the need for further treatment in the longer term.