Comparison of Two Surgical Techniques for Open Subpectoral Biceps Tenodesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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

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Bicep Tenodesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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One Anchor

Participant will receive one standard anchor during standard biceps tenodesis procedure

Group Type EXPERIMENTAL

One Anchor

Intervention Type PROCEDURE

Participant will receive one standard anchor

Two Mini Anchors

Participant will receive two mini anchors during standard biceps tenodesis procedure

Group Type EXPERIMENTAL

Two Mini Anchors

Intervention Type PROCEDURE

Participant will receive two mini anchors

Interventions

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One Anchor

Participant will receive one standard anchor

Intervention Type PROCEDURE

Two Mini Anchors

Participant will receive two mini anchors

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes