Effect of Ligashot inLigament injury
- Conditions
- Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified
- Registration Number
- CTRI/2023/09/057919
- Lead Sponsor
- Innovcare LifeSciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Male or female patients aged more than 18 years with grade 1 and 2 Ligament 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 ligament surgery of the involved knee;
2. Torn or avulsed patellar or quadriceps 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. Surgical procedures that precludes early weight-bearing or range of motion.
9. Any condition that would preclude the ability to comply with post-operative guidelines
10. Moderate to severe renal impairment
11. Pregnant or lactating
12. History of hypersensitivity to any of the test products.
13. 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. <br/ ><br>2. Time to return to pre-injury level of activity. <br/ ><br>3. Multiple Ligament <br/ ><br>Quality of Life (MLQoL) Questionnaire. <br/ ><br>4. Change in ESR and CRP <br/ ><br>5. Global rating change <br/ ><br>6. MRI assessment <br/ ><br>Timepoint: Day 0 and week 12 <br/ ><br>
- Secondary Outcome Measures
Name Time Method To demonstrate safety and tolerability of study product by Clinical AEs, <br/ ><br>including laboratory abnormalities (If any) <br/ ><br>Safety and tolerability evaluation criteria: <br/ ><br>Adverse events and serious adverse events during the study periodTimepoint: Day 0, Week 4, Week 8 , Week 12