NCT05278897|Unknown
Hyaluronic Acid for Soft Tissue Injuries
SAFE
Soft Tissue Adapted Hyaluronic Acid Functional Evaluation (SAFE): A Prospective Study
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SAFE
Soft Tissue Adapted Hyaluronic Acid Functional Evaluation (SAFE): A Prospective Study
Sponsor study identifier
interventional
200
0 countries
N/A
Study Start
March 14, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 13, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 13, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 13, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2, 2022
Actual (reported)March 14, 2022
Actual (reported)March 14, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 13, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 13, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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).
1% sodium hyaluronate
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mohit Bhandari
Global Research Solutions
First Submitted
March 2, 2022
First Posted
March 14, 2022
Study Start
March 14, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 13, 2024
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 13, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 14, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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