Hyaluronic Acid for Soft Tissue Injuries (SAFE)
Primary Purpose
Elbow Tendinopathy, Ankle Sprains
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Soft Tissue Adapted Biocompatible Hyaluronic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Elbow Tendinopathy
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years of age or older.
Having a STABHA™ injection for the treatment of:
- Acute first or second degree ankle sprain (e.g. occurred within the past 48 hours).
- Lateral epicondylitis (tennis elbow).
- Informed consent obtained.
Exclusion Criteria:
- Medical contraindication to STABHA™.
- Previous treatment with STABHA™.
- Ankle or foot fracture.
- Bilateral ankle sprain.
- Previous ankle sprain in the past 12 months.
- Prior surgical management of the ankle or elbow.
- Current or anticipated incarceration.
- Terminal illness with expected survival less than 90 days.
- Currently enrolled in a study that does not permit co-enrollment.
- Unable to obtain informed consent due to language barriers.
- Unable to comply with the protocol.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Prior enrollment in the study.
- Other reason to exclude the patient, as approved by the Sponsor.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Soft Tissue Adapted Biocompatible Hyaluronic Acid
Arm 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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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-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.
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.
Adverse Events
Any adverse event experienced by the patient will be recorded at all follow-ups.
Full Information
NCT ID
NCT05278897
First Posted
March 2, 2022
Last Updated
March 9, 2022
Sponsor
Global Research Solutions
Collaborators
Pendopharm
1. Study Identification
Unique Protocol Identification Number
NCT05278897
Brief Title
Hyaluronic Acid for Soft Tissue Injuries
Acronym
SAFE
Official Title
Soft Tissue Adapted Hyaluronic Acid Functional Evaluation (SAFE): A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 14, 2022 (Anticipated)
Primary Completion Date
May 13, 2024 (Anticipated)
Study Completion Date
May 13, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Global Research Solutions
Collaborators
Pendopharm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Tendinopathy, Ankle Sprains
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Soft Tissue Adapted Biocompatible Hyaluronic Acid
Arm Type
Experimental
Arm 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).
Intervention Type
Device
Intervention Name(s)
Soft Tissue Adapted Biocompatible Hyaluronic Acid
Intervention Description
1% sodium hyaluronate
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Pain
Description
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 Outcome Measure Information:
Title
EuroQol-5 Dimensions (EQ-5D)
Description
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
Title
12-Item Short Form Survey Version 1 (SF-12V1)
Description
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
Title
Pain medication use
Description
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
Title
Adverse Events
Description
Any adverse event experienced by the patient will be recorded at all follow-ups.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18 years of age or older.
Having a STABHA™ injection for the treatment of:
Acute first or second degree ankle sprain (e.g. occurred within the past 48 hours).
Lateral epicondylitis (tennis elbow).
Informed consent obtained.
Exclusion Criteria:
Medical contraindication to STABHA™.
Previous treatment with STABHA™.
Ankle or foot fracture.
Bilateral ankle sprain.
Previous ankle sprain in the past 12 months.
Prior surgical management of the ankle or elbow.
Current or anticipated incarceration.
Terminal illness with expected survival less than 90 days.
Currently enrolled in a study that does not permit co-enrollment.
Unable to obtain informed consent due to language barriers.
Unable to comply with the protocol.
Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
Prior enrollment in the study.
Other reason to exclude the patient, as approved by the Sponsor.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Phillips
Phone
1-289-337-8717
Email
steve.phillips@myorthoevidence.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohit Bhandari
Organizational Affiliation
Global Research Solutions
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Hyaluronic Acid for Soft Tissue Injuries
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