Hyaluronic Acid for Soft Tissue Injuries (SAFE)

Global Research Solutions

Status: Unknown

Conditions: Ankle Sprains; Elbow Tendinopathy

Treatments: Device: Soft Tissue Adapted Biocompatible Hyaluronic Acid

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05278897

001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients 18 years of age or older.

2. Having a STABHA™ injection for the treatment of:

   1. Acute first or second degree ankle sprain (e.g. occurred within the past 48 hours).
   2. Lateral epicondylitis (tennis elbow).

3. Informed consent obtained.

Exclusion criteria

1. Medical contraindication to STABHA™.
2. Previous treatment with STABHA™.
3. Ankle or foot fracture.
4. Bilateral ankle sprain.
5. Previous ankle sprain in the past 12 months.
6. Prior surgical management of the ankle or elbow.
7. Current or anticipated incarceration.
8. Terminal illness with expected survival less than 90 days.
9. Currently enrolled in a study that does not permit co-enrollment.
10. Unable to obtain informed consent due to language barriers.
11. Unable to comply with the protocol.
12. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
13. Prior enrollment in the study.
14. Other reason to exclude the patient, as approved by the Sponsor.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Soft Tissue Adapted Biocompatible Hyaluronic Acid

Experimental group

Description:

Soft Tissue Adapted Biocompatible Hyaluronic Acid is a clear solution of sterile 1% sodium hyaluronate (10 mg/mL) contained in a 1.2 mL pre-filled syringe. Patients will receive two injections, spaced 2 to 3 days apart (for ankle sprains) or 7 days apart (for elbow injections).

Treatment:

Device: Soft Tissue Adapted Biocompatible Hyaluronic Acid