Hyaluronic Acid for Soft Tissue Injuries

NCT05278897 | Unknown

• 1 other identifier: 001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Elbow Tendinopathy; Ankle Sprains

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• EuroQol-5 Dimensions (EQ-5D)

  12 months

• 12-Item Short Form Survey Version 1 (SF-12V1)

  12 months

• Pain medication use

  12 months

• Adverse Events

  12 months

Study Arms (1)

Soft Tissue Adapted Biocompatible Hyaluronic Acid

EXPERIMENTAL

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

Interventions

Soft Tissue Adapted Biocompatible Hyaluronic Acid DEVICE

1% sodium hyaluronate

Soft Tissue Adapted Biocompatible Hyaluronic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Global Research Solutions: lead
• Pendopharm: collaborator

MeSH Terms

Conditions

Elbow Tendinopathy; Ankle Injuries

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Leg Injuries

Study Officials

• Mohit Bhandari

  Global Research Solutions

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Phillips

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 14, 2022
• Study Start: March 14, 2022
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: March 14, 2022

Record last verified: 2022-03