A prospective, interventional, randomized, comparative open-label pivotal clinical study to assess the efficacy of Serioss® as bone void filler/bone substitute.

Serigen Mediproducts Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

研究概览

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•To be eligible for the study, patients must fulfill all inclusion criteria listed below:
•1 Male and female participants aged above 18 years
•2 Patients with any bone void in the extremities (both upper and lower) which requires surgical reconstruction using autografting/ allografting including but not limited to depressed intra articular fracture of upper end of tibia, proximal humerus, distal radius, distal femur, proximal femur and calcaneus; acute traumatic conditions requiring bone void filling surgery / non traumatic conditions like Open wedge osteotomy for deformity correction
•3 Full comprehension, willingness to give informed consent and willingness to comply with all the study requirements

•Patients meeting any of the following exclusion criteria will not be eligible for participation in
•1 Patients with clinically significant medical conditions such as hepatorenal failure, uncontrolled diabetes, long standing steroid intake etc.
•2 Patients with active infections of bone or HIV/Hepatitis B/C, pathological fractures.
•3 Subject should not have any known history suggestive of hypersensitivity or allergies to the materials used in the product.

发起方

Serigen Mediproducts Pvt Ltd