Surgical Techniques for Shoulder Impingement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two surgical techniques for treating shoulder pain caused by biceps tendinopathy, a condition where the biceps tendon becomes inflamed or damaged. Participants will undergo a standard procedure to secure the biceps tendon using either one standard anchor or two smaller anchors. Both methods are safe and commonly used. The trial seeks participants who have been advised to undergo this surgery due to biceps tendinopathy, with or without related rotator cuff issues, and who have not had previous surgery or injury to their biceps. As an unphased trial, this study offers participants the chance to contribute to medical knowledge and potentially improve future treatment options.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these surgical techniques are safe for shoulder impingement?
Studies have shown that biceps tenodesis, a surgery often used for shoulder problems, is generally safe. Research indicates a low rate of complications for those undergoing the procedure with one anchor. In one study, only about 6.9% of patients experienced complications within the first six months. Another study found that patients who had the procedure with a single anchor reported high satisfaction and improved shoulder function.
Research also suggests that the two mini anchors approach is well-tolerated. Studies have reported a low rate of early complications, with no deep infections or nerve injuries. This method has led to excellent or good results in most cases.
Overall, both techniques are considered standard and safe options for treating certain shoulder issues. These findings may help prospective trial participants feel more comfortable about the safety of the treatments being studied.12345Why are researchers excited about this trial?
Researchers are excited about these surgical techniques for shoulder impingement because they explore innovative anchor configurations during biceps tenodesis. The "One Anchor" approach uses a single standard anchor, which aims to provide a more straightforward and potentially quicker procedure. Meanwhile, the "Two Mini Anchors" technique involves using two smaller anchors, potentially offering greater stability and less damage to surrounding tissue. By comparing these methods, researchers hope to discover which technique offers better outcomes, such as reduced recovery time or improved shoulder function, compared to traditional surgical methods.
What evidence suggests that this trial's surgical techniques could be effective for shoulder impingement?
This trial will compare two surgical techniques for shoulder impingement: the single anchor method and the two mini anchors method. Studies have shown that both techniques lead to good outcomes. Participants may receive the single anchor method, which often results in high satisfaction and significant improvement in shoulder function. Research indicates few complications, with most patients experiencing less pain and better movement. Alternatively, participants may receive the two mini anchors method, which has also produced positive results, with many patients feeling satisfied and noticing improvements. Both methods effectively stabilize the shoulder and enhance quality of life.678910
Who Is on the Research Team?
Michael Freehill, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Procedure
Participants undergo the standard biceps tenodesis procedure using either one standard anchor or two mini anchors. A sterile radiolucent bead is applied to the tendon.
Post-operative Imaging
X-ray imaging is conducted in the post-anesthesia care unit to determine a baseline measurement of the radiolucent bead location.
Follow-up
Participants undergo further x-ray imaging and report outcomes at 2-week and 6-month follow-up visits.
What Are the Treatments Tested in This Trial?
Interventions
- One Anchor
- Two Mini Anchors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor