Management of bone loss by surgery using synthetic ceramics loaded with stem cells
Phase 1
Completed
- Conditions
- Health Condition 1: M865- Other chronic hematogenous osteomyelitisHealth Condition 2: M845- Pathological fracture in neoplastic diseaseHealth Condition 3: null- Segmental bone defects following resection of tumor, infection or trauma in children
- Registration Number
- CTRI/2014/09/005027
- Lead Sponsor
- Department of Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Children over one year of age with large bone defects following tumor resection post-traumatic bone loss, post infective bone loss or loss due to any other causes with a good intact soft tissue envelope and giving consent for the experimental treatment
Exclusion Criteria
i)Active infection
ii)Poor soft tissue cover
iii) Patients who are not likely to come for a full review process of 2 years
iv)Patients who are not likely to survive for 2 years due to their disease process
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiographic union of the grat at both ends <br/ ><br> <br/ ><br>Any major adverse eventTimepoint: follow ups at 2 weeks after surgery. seusequently 2 months, 3 months, 6 months, 9 months, one year, one and half years and 2 years <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.To assess the osteoblastic activity in serum. <br/ ><br>2. pixel assessment and CT assessemt after implant removalTimepoint: Bone specific alkaline phosphatase at 2weeks and 2 months <br/ ><br> <br/ ><br>