45
Participants
Start Date
June 18, 2024
Primary Completion Date
June 30, 2029
Study Completion Date
June 30, 2029
FITBONE® Lengthening Nail
"The patient is installed on a standard orthopaedic table, intramedullary reaming is performed through a metal working tube. The osteotomy is performed percutaneously and then an osteotome according to the postage-stamp technique. Once the FITBONE lengthening nail is placed in the desired location, it should be connected to the subcutaneous receiver. The receiver should be placed close enough to the skin surface to ensure the energy transfer from the external transmitter.~After 5 to 10 days after surgery, the lengthening mechanism is operated by the patient, using the transmitter. An elongation of approximately 1 mm/day takes place. The attending physician determines the rhythm of lengthening in each case. When the desired elongation length is reached, the consolidation phase begins, which is necessary for bone regeneration. The FITBONE lengthening nail can be removed once the bone has consolidated, approximately one to one and a half years after implantation."
RECRUITING
Hôpital Sainte-Marguerite AP-HM, Marseille
RECRUITING
Centre hospitalier universitaire (CHU) de Toulouse, Toulouse
RECRUITING
CHU de Saint-Étienne Hôpital Nord, Saint-Etienne
RECRUITING
CHU Lille - Hôpital Jeanne de Flandre, Lille
RECRUITING
CHU de Strasbourg, Strasbourg
RECRUITING
CHU de La Réunion site Sud Saint-Pierre, Saint-Pierre
Orthofix s.r.l.
INDUSTRY