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Responsible party decision, not to proceed with the study.
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Participants who are indicated for an open biceps tenodesis procedure will be recruited to join the study. The participant will undergo the standard biceps tenodesis procedure using either one standard anchor or two mini anchors by the study staff surgeon. Both techniques are safe and considered standard of care. The participant will be randomized to either group. After the biceps are secured in the standard fashion, a sterile radiolucent bead will be applied to the tendon. The participant will undergo xray imaging in the post-anesthesia care unit to determine a baseline measurement of the location of the radiolucent bead. The participant will then undergo further xray imaging at their 2 week and 6 month-up visits.
Participants who are indicated for an open biceps tenodesis procedure will be recruited to join the study. The participant will undergo the standard biceps tenodesis procedure using either one standard anchor or two mini anchors by the study staff surgeon. Both techniques are safe and considered standard of care. The participant will be randomized to either group. After the biceps are secured in the standard fashion, a sterile radiolucent bead will be applied to the tendon. This will allow for measurements to be made on xray imaging in the post-operative period. The placement of the clip is the only experimental portion of the procedure. The participant will undergo xray imaging in the post-anesthesia care unit to determine a baseline measurement of the location of the radiolucent bead. The participant will then undergo further xray imaging at their 2 week and 6 month-up visits. These visits are standard visits for the participant who undergo this procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One Anchor | Experimental | Participant will receive one standard anchor during standard biceps tenodesis procedure |
|
| Two Mini Anchors | Experimental | Participant will receive two mini anchors during standard biceps tenodesis procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One Anchor | Procedure | Participant will receive one standard anchor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sterile radiolucent bead location distance | Sterile radiolucent bead location will be measured during all 3 xrays. Comparison of these measurements will be between the two groups. | Baseline, 2-weeks, 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Reported Outcome VAS | Change in Visual Analog Scale (VAS); minimum 0, maximum 10, higher score is a worse outcome | 2-weeks, 6-months |
| Participant Reported Outcome Constant | Constant Score; minimum 0, maximum 100, higher score is a better outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Freehill, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| Two Mini Anchors |
| Procedure |
Participant will receive two mini anchors |
|
| 2-weeks, 6-months |
| Participant Reported Outcome ASES | American Shoulder Elbow Score (ASES); minimum 0, maximum 100, higher score is a better outcome | 2-weeks, 6-months |
| Participant Reported Outcome SSV | Subjective Shoulder Value (SSV); minimum 0, maximum 100, higher score is a better outcome | 2-weeks, 6-months |