Comparison of Two Surgical Techniques for Open Subpectoral Biceps Tenodesis

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bicep Tenodesis
• Intervention / Treatment: Procedure: One Anchor; Procedure: Two Mini Anchors

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One Anchor; Participant will receive one standard anchor during standard biceps tenodesis procedure	Procedure: One Anchor; Participant will receive one standard anchor
Experimental: Two Mini Anchors; Participant will receive two mini anchors during standard biceps tenodesis procedure	Procedure: Two Mini Anchors; Participant will receive two mini anchors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Michael Freehill, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 77635

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No