CTRI/2023/10/058843
Recruiting
未知
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 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: M844- Pathological fracture, not elsewhere classified
- Sponsor
- Serigen Mediproducts Pvt Ltd
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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