Status:
UNKNOWN
Hyaluronic Acid for Soft Tissue Injuries
Lead Sponsor:
Global Research Solutions
Collaborating Sponsors:
Pendopharm
Conditions:
Elbow Tendinopathy
Ankle Sprains
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Soft Tissue Adapted Biocompatible Hyaluronic Acid, or STABHA™, has demonstrated varying degrees efficacy in patients treated for common musculoskeletal tendinopathies and ligament injuries, such as an...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older.
- Having a STABHA™ injection for the treatment of:
- Acute first or second degree ankle sprain (e.g. occurred within the past 48 hours).
- Lateral epicondylitis (tennis elbow).
- Informed consent obtained.
Exclusion
- Medical contraindication to STABHA™.
- Previous treatment with STABHA™.
- Ankle or foot fracture.
- Bilateral ankle sprain.
- Previous ankle sprain in the past 12 months.
- Prior surgical management of the ankle or elbow.
- Current or anticipated incarceration.
- Terminal illness with expected survival less than 90 days.
- Currently enrolled in a study that does not permit co-enrollment.
- Unable to obtain informed consent due to language barriers.
- Unable to comply with the protocol.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Prior enrollment in the study.
- Other reason to exclude the patient, as approved by the Sponsor.
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 13 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05278897
Start Date
March 14 2022
End Date
May 13 2024
Last Update
March 14 2022
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