Reason for request

Re-assessment of the actual benefit and the improvement in actual benefit

Low actual benefit and no clinical benefit demonstrated in tibia fractures and lumbar degenerative disc disease with anterior lumbar interbody fusion

  • INDUCTOS has Marketing Authorisation in the treatment of tibia fractures and as a substitute for autogenous bone grafts in lumbar interbody fusion (See below).
  • In the treatment of tibia fractures, the use of INDUCTOS is marginal The company was not able to perform the follow-up study requested in this indication in 2003.
  • In the treatment of lumbar degenerative disc disease with anterior lumbar interbody fusion, its superiority compared with autogenous bone grafts has not been demonstrated with a rigorous methodology. 




Clinical Benefit

Low

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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Évaluation des médicaments