Comparison of Two Surgical Techniques for Open Subpectoral Biceps Tenodesis

Not Applicable

Not yet recruiting

• Conditions: Bicep Tenodesis

• Registration Number: NCT06797128
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Study First Posted: 2025-01-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Study Start: 2026-01
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States