Hyaluronic Acid for Soft Tissue Injuries (SAFE)

Soft Tissue Adapted Hyaluronic Acid Functional Evaluation (SAFE): A Prospective Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Elbow Tendinopathy; Ankle Sprains
• Intervention / Treatment: Device: Soft Tissue Adapted Biocompatible Hyaluronic Acid

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven Phillips; Phone Number: 1-289-337-8717; Email: steve.phillips@myorthoevidence.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: Soft Tissue Adapted Biocompatible Hyaluronic Acid; 1% sodium hyaluronate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Pain	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol-5 Dimensions (EQ-5D)	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 months
12-Item Short Form Survey Version 1 (SF-12V1)	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.	12 months
Pain medication use	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.	12 months
Adverse Events	Any adverse event experienced by the patient will be recorded at all follow-ups.	12 months

Collaborators and Investigators

• Sponsor: Global Research Solutions
• Collaborators: Pendopharm
• Investigators: Principal Investigator: Mohit Bhandari, Global Research Solutions

Study record dates

Study Major Dates

• Study Start (Anticipated): March 14, 2022
• Primary Completion (Anticipated): May 13, 2024
• Study Completion (Anticipated): May 13, 2024

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Ankle Injuries; Elbow Tendinopathy; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No