Bicep Tenodesis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREOne Anchor
Participant will receive one standard anchor
PROCEDURETwo Mini Anchors
Participant will receive two mini anchors
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant age 18 and above who would otherwise indicated for biceps tenodesis due to biceps tendinopathy with or without associated rotator cuff pathology
Exclusion criteria
* Participant under the age of 18 will be excluded from the study as there is no indication to perform this procedure in children. * Any participant who had previous surgery or injury to their biceps or biceps tendon will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sterile radiolucent bead location distance | Baseline, 2-weeks, 6-months | Sterile radiolucent bead location will be measured during all 3 xrays. Comparison of these measurements will be between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Reported Outcome VAS | 2-weeks, 6-months | Change in Visual Analog Scale (VAS); minimum 0, maximum 10, higher score is a worse outcome |
| Participant Reported Outcome Constant | 2-weeks, 6-months | Constant Score; minimum 0, maximum 100, higher score is a better outcome |
| Participant Reported Outcome ASES | 2-weeks, 6-months | American Shoulder Elbow Score (ASES); minimum 0, maximum 100, higher score is a better outcome |
| Participant Reported Outcome SSV | 2-weeks, 6-months | Subjective Shoulder Value (SSV); minimum 0, maximum 100, higher score is a better outcome |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Freehill, MD
Stanford University
Outcome results
None listed