Serioss® Bone Study: Testing How Well It Can Fill Empty Spaces in Bones
- Conditions
- Health Condition 1: M844- Pathological fracture, not elsewhere classified
- Registration Number
- CTRI/2023/10/058843
- Lead Sponsor
- Serigen Mediproducts Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate bone formation and integration at the site where Serioss ® is <br/ ><br>used; and to establish non-inferiority of Serioss ® in comparison with tri-calcium phosphate <br/ ><br>bone void filler.Timepoint: At all visits
- Secondary Outcome Measures
Name Time Method Secondary objectives: <br/ ><br>• Evaluation of extent of bone healing/regeneration by CT (via radiological analysis by <br/ ><br>expert) at 6 months <br/ ><br>• Surgical outcomes like operative time, length of hospital stay, complications etc., <br/ ><br>functional outcomes of the operated limb/area as determined by post operative <br/ ><br>movement.Timepoint: Visit 6