Effect of treatment with ossein-hydroxyapatite compound on the time of fracture-healing”. A prospective, multicenter, double-blind, randomised, placebo controlled clinical trial.

Overview

No summary available.

Registry

who.int

Start Date

January 27, 2011

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•To be included in the trial, patients should fulfill the following criteria:
•\- male or menopausal female between 50 and 80 years of age,
•\- a recent closed Colles’ fracture (\< 48 hours ), correctly reduced and stabilised with Kirschner wires,
•\- willing, able to understand and sign an approved Informed Consent Form,
•\- able to understand the protocol and to come to the control visits,
•\- registered with a social security or health insurance system (if applicable).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•Patients fulfilling at least one of the following criteria cannot be included in the study:
•\- a criterion connected to pathologies:
•\- Patient with an open fracture,
•\- Patient with a bilateral Colles’ fracture or multiple concurrent fractures or injuries,
•\- Patient with fracture which may require a surgical treatment during the study treatment,
•\- Patient having had a fracture of the upper limb or a prolonged immobilization during the 12 months preceding the inclusion,
•\- Patient having had a functional impairment of the hand or the forearm before injury,
•\- Patient with a pathological fractures related to cancer,
•\- Patient with hereditary bone disease,
•\- Patient with bone necrosis,