Hyaluronic Acid for Soft Tissue Injuries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-14

Study Completion Date

2024-05-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Elbow Tendinopathy Ankle Sprains

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Soft Tissue Adapted Biocompatible Hyaluronic Acid

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).

Group Type EXPERIMENTAL

Soft Tissue Adapted Biocompatible Hyaluronic Acid

Intervention Type DEVICE

1% sodium hyaluronate

Interventions

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Soft Tissue Adapted Biocompatible Hyaluronic Acid

1% sodium hyaluronate

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No