Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail

RecruitingOBSERVATIONAL
Enrollment

45

Participants

Timeline

Start Date

June 18, 2024

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2029

Conditions
Leg Length Inequality
Interventions
DEVICE

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."

Trial Locations (6)

13274

RECRUITING

Hôpital Sainte-Marguerite AP-HM, Marseille

31300

RECRUITING

Centre hospitalier universitaire (CHU) de Toulouse, Toulouse

42270

RECRUITING

CHU de Saint-Étienne Hôpital Nord, Saint-Etienne

59120

RECRUITING

CHU Lille - Hôpital Jeanne de Flandre, Lille

67091

RECRUITING

CHU de Strasbourg, Strasbourg

97448

RECRUITING

CHU de La Réunion site Sud Saint-Pierre, Saint-Pierre

All Listed Sponsors
lead

Orthofix s.r.l.

INDUSTRY