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| Name | Class |
|---|---|
| Vivex Biomedical | UNKNOWN |
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The proposed study aims to investigate whether amniotic fluid injections are a better alternative to corticosteroid injections as a conservative treatment for stenosing tenosynovitis. Based on results from our most recent pilot study exploring patient outcomes after receiving an amnion injection, we were able to observe symptom resolution in more than half of the study population. Adverse events were extremely rare and not related to study participation. Given the numerous occurrences of successful symptom resolution, the next step is to compare patient outcomes to those of patients who receive the standard steroid injection. This study will compare outcome measurements of patients who receive amnion injections to those who receive steroid injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid injection | Active Comparator | 1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine |
|
| Amniotic fluid injection | Experimental | 1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amniotic fluid injection | Biological | Amniotic fluid contains various proteins that support cell proliferation, movement and differentiation. Amniotic fluid also includes collagen substrates, growth factors, amino acids, polyamines, lipids, carbohydrates, cytokines, extracellular matrix molecules like hyaluronic acid and fibronectin, cells and other chemical compounds that are needed for tissue protection and repair. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported pain level | Analog pain scale (0-10) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Trigger frequency | Rate at which a patient's digit will lock or trigger | 12 months |
| Disabilities of the Arm Shoulder and Hand score | Measure of disability in performing every day activities at work and around the house. Calculated value from DASH questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Shuler, MD | Athens Orthopedic Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athens Orthopedic Clinic | Athens | Georgia | 30606 | United States |
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| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013256 | Steroids |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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|
| Steroid injection | Biological | Solu-medrol |
|
| 12 months |