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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
Global Research Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elbow Tendinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    March 2, 2022
    Last Updated
    March 9, 2022
    Sponsor
    Global Research Solutions
    Collaborators
    Pendopharm
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    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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