Bicep TenodesisNCT06797128
Comparison of Two Surgical Techniques for Open Subpectoral Biceps Tenodesis
A study testing One Anchor and Two Mini Anchors in people with Bicep Tenodesis, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bicep Tenodesis
- What is being tested?
- One Anchor and Two Mini Anchors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant age 18 and above who would otherwise indicated for biceps tenodesis due to biceps tendinopathy with or without associated rotator cuff pathology
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- One Anchor, Two Mini Anchors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One AnchorProcedure or surgery
Participant will receive one standard anchor
Two Mini AnchorsProcedure or surgery
Participant will receive two mini anchors
| Study group | Role | What they receive |
|---|---|---|
| One Anchor | Experimental | Participant will receive one standard anchor during standard biceps tenodesis procedure Receives: Procedure: One Anchor |
| Two Mini Anchors | Experimental | Participant will receive two mini anchors during standard biceps tenodesis procedure Receives: Procedure: Two Mini Anchors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2-weeks, 6-months
Secondary outcomes (4)
Participant Reported Outcome VAS
Change in Visual Analog Scale (VAS); minimum 0, maximum 10, higher score is a worse outcome
Measured: 2-weeks, 6-months
Participant Reported Outcome Constant
Constant Score; minimum 0, maximum 100, higher score is a better outcome
Measured: 2-weeks, 6-months
Participant Reported Outcome ASES
American Shoulder Elbow Score (ASES); minimum 0, maximum 100, higher score is a better outcome
Measured: 2-weeks, 6-months
Participant Reported Outcome SSV
Subjective Shoulder Value (SSV); minimum 0, maximum 100, higher score is a better outcome
Measured: 2-weeks, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Responsible party decision, not to proceed with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bicep TenodesisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael T. Freehill, Stanford University
- Investigators
- Michael Freehill, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797128
- Sponsor's protocol ID
- 77635
- Status last verified
- Apr 2025
- First submitted
- 21 Jan 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bicep Tendon Migration Between Two Techniques for Open Subpectoral Biceps Tenodesis
- ClinicalTrials.gov ID
- NCT06797128
- Acronym / sponsor ID
- 77635
- Conditions
- Bicep Tenodesis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Responsible party decision, not to proceed with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One Anchor | Experimental | Procedure: One AnchorParticipant will receive one standard anchor during standard biceps tenodesis procedure |
| Two Mini Anchors | Experimental | Procedure: Two Mini AnchorsParticipant will receive two mini anchors during standard biceps tenodesis procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participant age 18 and above who would otherwise indicated for biceps tenodesis due to biceps tendinopathy with or without associated rotator cuff pathology
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One AnchorParticipant will receive one standard anchor | Procedure or surgery | One Anchor |
| Two Mini AnchorsParticipant will receive two mini anchors | Procedure or surgery | Two Mini Anchors |
Primary outcome
Sterile radiolucent bead location distance
Time frame: 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.
4 secondary outcomes
Participant Reported Outcome VAS
Time frame: 2-weeks, 6-months
Participant Reported Outcome Constant
Time frame: 2-weeks, 6-months
Participant Reported Outcome ASES
Time frame: 2-weeks, 6-months
Participant Reported Outcome SSV
Time frame: 2-weeks, 6-months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Bicep Tenodesis
Recruiting
Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1)
Rotator Cuff Injury
Recruiting
Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears
SLAP Lesion
Active, not recruiting
Patient Outcomes Collection: How Can we do Better?
Shoulder Pain
Not yet recruitingObservational study
Impact of Rotator Cuff Repair on Rehabilitation Outcome
Rotator Cuff Repairs
Not yet recruiting
Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior ( SLAP) From Type II to Type IV
SLAP Lesion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Freehill, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One Anchor and Two Mini Anchors in people with Bicep Tenodesis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sterile radiolucent bead location distance (time frame: Baseline, 2-weeks, 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.