Health Condition 1: M844- Pathological fracture, not elsewhere classified
Conditions
Interventions
Intervention1: Serioss®: Serioss® as bone void filler
Control Intervention1: tri-calcium phosphate
bone void filler.: The patients in test cohort will receive Serioss® whereas the patients in the cont
Sponsors
Serigen Mediproducts Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Patients meeting any of the following exclusion criteria will not be eligible for participation in the study: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate bone formation and integration at the site where Serioss ® is used; and to establish non-inferiority of Serioss ® in comparison with tri-calcium phosphate bone void filler.Timepoint: At all visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: • Evaluation of extent of bone healing/regeneration by CT (via radiological analysis by expert) at 6 months • Surgical outcomes like operative time, length of hospital stay, complications etc., functional outcomes of the operated limb/area as determined by post operative movement.Timepoint: Visit 6 | — |
Countries
India
Contacts
Public ContactDr Aquil Faruqui
Serigen Mediproduts Pvt.Ltd
Outcome results
None listed