A clinical trial to study the effects of two different treatment methods, hormonal and cellular therapy in patients with fractures.
Phase 4
- Conditions
- Health Condition 1: S525- Fracture of lower end of radius
- Registration Number
- CTRI/2023/07/055488
- Lead Sponsor
- Datta Meghe Institute of Higher Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Closed/simple fractures of distal radius
Exclusion Criteria
1. Polytrauma/ Ipsilateral other fractures
2. Joint diseases of ipsilateral wrist, forearm and elbow.
3. Secondary osteoporosis due to any reason.
4. Elevated serum calcium
5. Known allergy to any form of PTH hormone or analogue
6. History of a Malignant neoplasm in the 5 years prior to the study
7. Hb% less than 10gm%
8. Low platelet count
9. Any conditions evidenced to delay normal healing
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Once the protocol has been applied, the groups will be followed up & outcomes will be assessed by the following methods: <br/ ><br>1) Laboratory investigations for serum alkaline phosphatase, serially performed on day 0 within 7 days of admission & 21 days after intervention. <br/ ><br>2) Serial radiological examination of wrist, anteroposterior and lateral views on day 0, 10, 18, 4 weeks & 6 weeks. <br/ ><br>Timepoint: On day 0 within 7 days of admission & 21 days after intervention, and on day 0, 10, 18, 4 weeks & 6 weeks. <br/ ><br>
- Secondary Outcome Measures
Name Time Method fracture healing rateTimepoint: at the end of 6 weeks