Hyaluronic Acid for Soft Tissue Injuries

Not Applicable

• Conditions: Ankle Sprains; Elbow Tendinopathy
• Interventions: Device: Soft Tissue Adapted Biocompatible Hyaluronic Acid

• Registration Number: NCT05278897
• Lead Sponsor: Global Research Solutions

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-09
• Last Update Submitted: 2022-03-09
• Study Start: 2022-03-14
• Study First Posted: 2022-03-14
• Last Update Posted: 2022-03-14
• Primary Completion: 2024-05-13
• Study Completion: 2024-05-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Soft Tissue Adapted Biocompatible Hyaluronic Acid	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).

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain	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 Outcome Measures

Name	Time	Method
Adverse Events	12 months	Any adverse event experienced by the patient will be recorded at all follow-ups.
EuroQol-5 Dimensions (EQ-5D)	12 months	A quality-of-life measurement instrument based on 5 dimensions of quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This brief questionnaire determines a quality of life score between 0 and 1, where 1 represents perfect health and 0 represents death.
12-Item Short Form Survey Version 1 (SF-12V1)	12 months	The SF-12 is a validated quality-of-life measurement tool that focuses on the impact of patient health on their everyday life. The SF-12 consists of 12 items that were developed to capture the physical and mental aspects of the patient's health status and is measured on a scale of -, with higher scores indicating better physical and mental health of the patient.
Pain medication use	12 months	The need for the patient to take pain medication for their injury/condition will be recorded using a 4-point Likert scale in order to determine if the treatment can reduce or cease the need for pain medication from medication use at baseline.