Soft Tissue Adapted Hyaluronic Acid Functional Evaluation (SAFE): A Prospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Elbow Tendinopathy
- Sponsor
- Global Research Solutions
- Enrollment
- 200
- Primary Endpoint
- Visual Analog Scale (VAS) Pain
- Last Updated
- 4 years ago
Overview
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 ankle sprains, lateral elbow tendinopathy, and rotator cuff tendinopathies. Factors associated with prognosis following treatment remain largely unknown. Identifying appropriate patient populations for use of STABHA™ is a necessary first step to facilitate the design of future clinical trials in the management of acute and chronic musculoskeletal soft-tissue injuries.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Visual Analog Scale (VAS) Pain
Time Frame: 12 months
A 100mm visual analog scale, with 0 representing no pain and 100 representing the worst pain imaginable. The patient will place an 'X' on the line which represents their current pain.
Secondary Outcomes
- Adverse Events(12 months)
- EuroQol-5 Dimensions (EQ-5D)(12 months)
- 12-Item Short Form Survey Version 1 (SF-12V1)(12 months)
- Pain medication use(12 months)