Elbow TendinopathySAFENCT05278897
Hyaluronic Acid for Soft Tissue Injuries
A study testing Soft Tissue Adapted Biocompatible Hyaluronic Acid in people with Elbow Tendinopathy and Ankle Sprains, run by Global Research Solutions.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Tendinopathy, Ankle Sprains
- What is being tested?
- Soft Tissue Adapted Biocompatible Hyaluronic Acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2022to 13 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Soft Tissue Adapted Hyaluronic Acid Functional Evaluation (SAFE): A Prospective Study
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
- Being tested
- Soft Tissue Adapted Biocompatible Hyaluronic Acid
- Medical subject headings
- Elbow Tendinopathy, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Tissue Adapted Biocompatible Hyaluronic AcidDevice
1% sodium hyaluronate
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Soft Tissue Adapted Biocompatible Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Adverse Events
Any adverse event experienced by the patient will be recorded at all follow-ups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start14 Mar 2022 (estimated)
- Primary completion13 May 2024 (estimated)
- Study completion13 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Research Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pendopharm
- Responsible party
- Sponsor
- Investigators
- Mohit Bhandari, Principal investigator, Global Research Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278897
- Sponsor's protocol ID
- 001
- Acronym
- SAFE
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Adapted Hyaluronic Acid Functional Evaluation (SAFE): A Prospective Study
- ClinicalTrials.gov ID
- NCT05278897
- Acronym / sponsor ID
- SAFE / 001
- Conditions
- Elbow Tendinopathy, Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Global Research SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Pendopharm
- Study start
- 14 Mar 2022 (estimated)
- Primary completion
- 13 May 2024 (estimated)
- Study completion
- 13 May 2024 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soft Tissue Adapted Biocompatible Hyaluronic Acid | Experimental | Device: Soft Tissue Adapted Biocompatible Hyaluronic AcidSoft 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18 years of age or older.
- Having a STABHA™ injection for the treatment of:
- Informed consent obtained.
Key exclusion criteria (14 listed)
- Medical contraindication to STABHA™.
- Previous treatment with STABHA™.
- Ankle or foot fracture.
- Bilateral ankle sprain.
- Previous ankle sprain in the past 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft Tissue Adapted Biocompatible Hyaluronic Acid1% sodium hyaluronate | Device | Soft Tissue Adapted Biocompatible Hyaluronic Acid |
Primary outcome
Visual Analog Scale (VAS) Pain
Time frame: 12 months
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.
4 secondary outcomes
EuroQol-5 Dimensions (EQ-5D)
Time frame: 12 months
12-Item Short Form Survey Version 1 (SF-12V1)
Time frame: 12 months
Pain medication use
Time frame: 12 months
Adverse Events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
Related trials for Elbow Tendinopathy
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohit Bhandari principal investigator
Global Research Solutions
Questions about this trial
What is this clinical trial studying?
A study testing Soft Tissue Adapted Biocompatible Hyaluronic Acid in people with Elbow Tendinopathy and Ankle Sprains, run by Global Research Solutions.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Phillips (1-289-337-8717, steve.phillips@myorthoevidence.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Pain (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.