Hyaluronic Acid for Soft Tissue Injuries

Global Research Solutions200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Elbow Tendinopathy Ankle Sprains

Interventions

Soft Tissue Adapted Biocompatible Hyaluronic AcidDEVICE

1% sodium hyaluronate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Adverse Events

Any adverse event experienced by the patient will be recorded at all follow-ups.

Time frame: 12 months

Central Contacts

Steven Phillips

CONTACT

1-289-337-8717 steve.phillips@myorthoevidence.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.