Clinical trial NCT01234415: Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction
Official title: Multicentric Pilot, Clinical Study of a Bone Substitute Safety and Efficacy in the Multi Traumatized Nasal Septum Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasal Septum
Keywords: nasal
septum
reconstruction
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Men and women between 18 and 60
* Indication of tissue replacement in a nasal septum, which skeleton is lacking or non usable for patients having:
* Paradoxal nasal obstruction with saddle nose type III and IV or flabby nose
* Nasal obstruction with an obstacle caused by a moved multifracture skeleton
* Written informed consent
* Patient with social insurance

Exclusion Criteria:

* Post-menopausal women : lack of efficient contraception (intra uterine dispositive or contraceptive pill)
* Breast feeding or pregnant women
* HIV or VHB or VHC seropositive subject
* Inflammatory or infectious active rhino sinusitis
* Nasal an sinus surgery or trauma ended from less than 8 months
* Toxic medicated Rhinitis to vasoconstrictors
* Diabetic : all type of diabetes (without or with therapy)
* Non treated cardiac disease
* Any contra indication to surgery
* Any contra indication to the biomaterial use like evolutive infection, bone disease or local necrosis
* Radiotherapy antecedent of the cephalic and cervical extremity
* Local or regional therapy with corticoids currently, or stopped from less than 2 months
* Patient participating to another study with an exclusion period still going on during pre-inclusion period

Primary outcomes:
measure: Safety
timeFrame: up to 6 months after surgery
measure: Epithelial cells affinity
timeFrame: up to 6 months after surgery
Secondary outcomes:
measure: Performance with Internal and external nasal shape assessment
timeFrame: month 2 and 6 after surgery.
measure: Performance with Functional Performance Assessment
timeFrame: pre operatively and post operatively at day 4, 10, and month 2 and 6 after surgery.
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - CHU de Bordeaux
city: Bordeaux
country: France
facility: Service d'Oto-rhino-laryngologie - Clinique St Augustin
city: Limoges
country: France
facility: Service d'Oto-rhino-laryngologie - Hôpital Dupuytren
Study officials:
affiliation: University Hospital, Bordeaux
name: Ludovic LE TAILLANDIER de GABORY, Dr
role: PRINCIPAL_INVESTIGATOR
References: