Surgical Techniques for Shoulder Impingement

Recruiting in Palo Alto (17 mi)

Overseen byMichael Freehill, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals who need an open biceps tenodesis surgery, which is a procedure to address shoulder impingement. Participants will be chosen randomly to receive the surgery with either one standard anchor or two mini anchors.

Inclusion Criteria

I am over 18 and need surgery for a biceps tendon issue, with or without shoulder problems.

Exclusion Criteria

I am 18 years old or older.

I have not had surgery or injury to my biceps or its tendon.

Participant Groups

The study compares two surgical techniques for attaching the biceps tendon in the shoulder. Patients will get either one larger anchor or two smaller ones during their procedure. The position of these anchors will be tracked using x-rays immediately after surgery and at follow-up visits.

2Treatment groups

Experimental Treatment

Group I: Two Mini AnchorsExperimental Treatment1 Intervention

Participant will receive two mini anchors during standard biceps tenodesis procedure

Group II: One AnchorExperimental Treatment1 Intervention

Participant will receive one standard anchor during standard biceps tenodesis procedure