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| Name | Class |
|---|---|
| Skye Biologics Holdings, LLC | INDUSTRY |
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The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ActiveMatrix® Dosage A | Experimental |
| |
| ActiveMatrix® Dosage B | Experimental |
| |
| Saline Injection | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActiveMatrix® Dosage A | Other | This group will receive ActiveMatrix® (AM) product dosage A (1cc AM diluted to 3cc with saline) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI) | Sugaya classification is a classification system that is used to analyze postoperative rotator cuff tendon integrity | 6 months post surgery , 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer | A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.PROM will be measured on both sides | baseline, 4weeks, 3 months, 6 months 9 months, and 12 months |
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Inclusion Criteria:
Reparable tear defined as:
a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension.
Full-thickness tear defined as:
a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric F Berkman, MD | Contact | 713-314-4112 | Eric.F.Berkman@uth.tmc.edu | |
| Layla Haidar | Contact | 713-486-5529 | Layla.Haidar@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eric F Berkman, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ActiveMatrix® Dosage B | Other | Group 2 will receive ActiveMatrix® product dosage B (2cc AM diluted to 3cc with saline) |
|
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| Saline injection | Procedure | Group 3 will receive saline injection |
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| Change in shoulder function as assessed by the American Shoulder and Elbow Surgeons Shoulder Score (ASES) | The total score is weighted 50% for pain and 50% for function. The pain score is calculated by subtracting the VAS from 10 and multiplying it by 5. The 10 functional questions are scored on a 4-point scale (0-3) with a maximum functional score of 30. The raw functional score is then multiplied by 5/3 to make the maximum functional score out of 50 possible points. The pain and function scores are then added together to obtain the final ASES score (out of 100). Higher scores correlate to better outcomes. | baseline, 4weeks, 3 months, 6 months 9 months, and 12 months |
| Change in pain intensity as assessed by the Visual Analog Scale (VAS) | VAS is scored on a 100mm horizontal scale that represents the patients pain intensity. A higher score corresponds to increased pain intensity | baseline, 4weeks, 3 months, 6 months 9 months, and 12 months |
| Change in pain and functional disability as assessed by the Shoulder Pain and Disability Index (SPADI) | SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. This contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability and each is scored from 0 = no pain and 10 = the worst pain imaginable. SPADI is scored from 0 to 130 with a high score representing more pain and disability. | baseline, 4weeks, 3 months, 6 months 9 months, and 12 months |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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