Clinical trial NCT06797128: Comparison of Two Surgical Techniques for Open Subpectoral Biceps Tenodesis
Official title: Comparison of Bicep Tendon Migration Between Two Techniques for Open Subpectoral Biceps Tenodesis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bicep Tenodesis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sterile radiolucent bead location distance
timeFrame: Baseline, 2-weeks, 6-months
Secondary outcomes:
measure: Participant Reported Outcome VAS
timeFrame: 2-weeks, 6-months
measure: Participant Reported Outcome Constant
timeFrame: 2-weeks, 6-months
measure: Participant Reported Outcome ASES
timeFrame: 2-weeks, 6-months
measure: Participant Reported Outcome SSV
timeFrame: 2-weeks, 6-months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Michael Freehill, MD
role: PRINCIPAL_INVESTIGATOR
References: