NCT06797128

Comparison of Two Surgical Techniques for Open Subpectoral Biceps Tenodesis

Comparison of Bicep Tendon Migration Between Two Techniques for Open Subpectoral Biceps Tenodesis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bicep Tenodesis

Interventions

Type	Name	Description
PROCEDURE	One Anchor	Participant will receive one standard anchor
PROCEDURE	Two Mini Anchors	Participant will receive two mini anchors

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-01-28
• Last updated: 2025-04-10

Locations

1 site across 1 country: United States