Effect OF TENDOSHOT PRO In Tendon Injury
- Conditions
- Health Condition 1: S869- Injury of unspecified muscle and tendon at lower leg level
- Registration Number
- CTRI/2024/03/064567
- Lead Sponsor
- Innovcare LifeSciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or female patients aged more than 18 years with
grade 1 and 2 Tendon Injury of knee, ankle or shoulder –
with or without dislocation.
2. Pain defined by a level of greater than or equal to 30 mm
on a 100 mm Visual Analogue Scale (VAS)
3. Patient should have not participated in any other clinical
trial during the past 3 months.
4. Participants, who are willing to give written, signed and
dated informed consent to participate in the study.
1. Prior knee/ankle /shoulder surgery;
2. Torn or avulsed tendon;
3. Periarticular or long bone fracture that is
anticipated to preclude weight-bearing after surgery;
4. Require use of an external fixator for greater than 10 days;
5. Planned staged surgical treatment;
6. Unable to weight bear on the contralateral uninjured leg;
7. Traumatic brain injury (TBI) that limits their ability to
participate in their post-operative care;
8. Any condition that would preclude the ability to comply with
post-operative guidelines
9. Moderate to severe renal impairment
10. Pregnant or lactating
11. History of hypersensitivity to any of the test products.
12. Any condition decided as unfit for study by Clinical
investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change from baseline to 16 weeks in pain intensity measured by Pain VAS Scale (0-100 mm) <br/ ><br>2.Time to Return to Pre-Injury Level of Activity <br/ ><br>3.Change from baseline to 12 weeks in ESR and CRP levels <br/ ><br>4. quality of life <br/ ><br>5. Global rating of change <br/ ><br>Timepoint: Baseline and 12 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method To demonstrate safety and tolerability of study product by Clinical <br/ ><br>AEs, including laboratory abnormalities (If any) <br/ ><br>Safety and tolerability evaluation criteria: <br/ ><br>Adverse events and serious adverse events during the study periodTimepoint: Baseline and 12 weeks