Repairing your growing bone ends with your own cells.
Phase 1
- Conditions
- Health Condition 1: null- Limb deformity due to physeal damage caused by trauma or infectionHealth Condition 2: T758- Other specified effects of external causes
- Registration Number
- CTRI/2018/09/015832
- Lead Sponsor
- Department of Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
The subject should
Be of pediatric age group with a growth plate defect amenable to treatment
Should have a definitive growth plate defect of 10 to 60% to on imaging MRI
Should be Indian nationals and able to come for follow up regularly
Exclusion Criteria
Subjects with chronic illness.
Subjects on long term medications.
Subjects with active infection and inflammation on the growth plate.
Subjects not suitable for surgery due to any other reasons.
Subject unable to come for a minimum of 2 years follow up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method I.Primary outcome <br/ ><br>Integration of the transplant with the existing growth plate verified using radiograph. <br/ ><br> <br/ ><br> <br/ ><br>II.Secondary outcome <br/ ><br> <br/ ><br>The transplant gaining a synergistic function along with the growth plate leading to normal growth rate in the affected limb and prevention of anticipated complications such as physeal bars, limb shortening and angulations. <br/ ><br> <br/ ><br>The efficacy is measured by radiographs and clinical examinations <br/ ><br>Timepoint: 3 months, 6 months, 9 months(optional), 1 year, 18 months, 2 years
- Secondary Outcome Measures
Name Time Method premature closure or any other abnormality of growth plate <br/ ><br>Timepoint: 2 years