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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
60
Participant will receive one standard anchor
Participant will receive two mini anchors
Stanford University
Stanford, California, United States
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.
Time frame: Baseline, 2-weeks, 6-months
Participant Reported Outcome VAS
Change in Visual Analog Scale (VAS); minimum 0, maximum 10, higher score is a worse outcome
Time frame: 2-weeks, 6-months
Participant Reported Outcome Constant
Constant Score; minimum 0, maximum 100, higher score is a better outcome
Time frame: 2-weeks, 6-months
Participant Reported Outcome ASES
American Shoulder Elbow Score (ASES); minimum 0, maximum 100, higher score is a better outcome
Time frame: 2-weeks, 6-months
Participant Reported Outcome SSV
Subjective Shoulder Value (SSV); minimum 0, maximum 100, higher score is a better outcome
Time frame: 2-weeks, 6-months
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