Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pendopharm | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Soft Tissue Adapted Biocompatible Hyaluronic Acid, or STABHAâ„¢, 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 STABHAâ„¢ is a necessary first step to facilitate the design of future clinical trials in the management of acute and chronic musculoskeletal soft-tissue injuries.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft Tissue Adapted Biocompatible Hyaluronic Acid | Device | 1% sodium hyaluronate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 months |
Not provided
Inclusion Criteria:
Patients 18 years of age or older.
Having a STABHAâ„¢ injection for the treatment of:
Informed consent obtained.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Phillips | Contact | 1-289-337-8717 | steve.phillips@myorthoevidence.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohit Bhandari | Global Research Solutions | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 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. | 12 months |
| Adverse Events | Any adverse event experienced by the patient will be recorded at all follow-ups. | 12 months |
| D001134 |
| Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D007869 | Leg Injuries |