Synthetic bone patch could rebuild noses without extra surgery
NCT ID NCT01234415
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a man-made bone material to repair the nasal septum in people with severe nose injuries from trauma. 26 adults received the material during rhinoplasty. The goal was to see if it is safe and effective at supporting the nose and helping the lining grow back, potentially avoiding the need to take bone from elsewhere in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- synthetic bone material (HAP/TCP, BCP, Kasios®)
- What this could lead to
- If successful, this could offer a safer, simpler way to reconstruct the nose after severe injury, avoiding the need for a second surgical site to harvest bone.
- What could go wrong
- This is a small, early-phase trial with only 26 participants, so results may not apply to everyone. Risks include infection, material extrusion, and chronic inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
26 people
The number who actually took part.
- Start date
-
Sep 2011
- Finished
-
Nov 2014
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Service d'Oto-rhino-laryngologie - Clinique St Augustin
Bordeaux, 33074, France
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Service d'Oto-rhino-laryngologie - Hôpital Dupuytren
Limoges, 87042, France
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Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - CHU de Bordeaux
Bordeaux, 330176, France