Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction
Condition: Nasal Septum
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this project is to evaluate the safety and efficacy of the biomaterial made of
      HAP/TCP (BCP, Kasios®), in septoplasties of multi traumatized human nose. The use of this
      biomaterial will avoid the graft sampling and we expect it to be a good substitute to support
      the nasal pyramid while favouring the respiratory epithelium regeneration. Thus, that would
      confirm previous in vitro and in vivo studies.
    

Detailed description: 
      Five to ten percent of the post-traumatic septo-rhinoplasties require a total reconstruction
      of the septal skeleton. This surgery requires using autologous bone graft (iliac, costal, or
      parietal). However these swabs include surgical risks, have a particular morbidity non
      negligible and particular quality imperfections (resorption level, texture, shape,
      integration) requiring a complex and long lasting shaping before implantation. To avoid the
      using of bone graft, a large scale of products has been developed to propose a synthetic bone
      substitute as a support for bone reconstruction. The bone substitute, BCP, made of hydroxyl
      apatite (HAP) and tricalcium phosphate (TCP), is thus largely used in orthopaedics, and CE
      marked in numerous indications (like sinus lift). The stake is to validate that it can be
      used in septo-rhino-plasties. This septic zone presents characteristics which required in
      vitro and in vivo studies, showing that the conclusions are a good biocompatibility of BCP
      for human epithelial cells and in septal area of rabbits and sheep. The ultimate step to
      validate this concept consists in conducting a pilot clinical study on 25 patients with the
      indication of septoplasties to verify its safety and efficacy in clinical conditions. This
      study will have an 18 months inclusion period and 6 months of follow up. The principal
      objective is to assess the HAP/TCP biomaterial safety and to confirm clinically and
      histologically the good affinity of human epithelial cells for this material. Secondary
      objective is to demonstrate that the restoration of the normal nasal anatomy with the
      material re-establishes the nasal respiratory shape and function. Clinical data,
      questionnaires, and photos will be collected pre operatively and at day 4, 10, and month 2
      and 6 after surgery. The endonasal biopsy and fiberoptic endoscopy will be realised at 2 and
      6 months post operatively and will be supplementary to the routine care protocol of the
      surgeon.
    

Intervention name(s): Rhinoplasty
Intervention type(s): Device
Intervention description(s): Rhinoplasty is performed under general anaesthesia; the duration is 1 to 2 hours. The surgical approach for implantation of the biomaterial is external rhinoplasty. The incision is made at the columella (base of nose) and becomes internal for the scar to be as unobtrusive as possible. The septum skeleton is then destroyed in order to place the synthetic biomaterial. The biomaterial is remodelled in order to have a natural external aspect of the nose. The incision is closed and the wicks are put in place in the nose for 4 days. A cast and a sticker will be put in place after surgery to maintain properly the biomaterial.
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nasal; septum; reconstruction