Surgical Techniques for Shoulder Impingement

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Under 18, Previous biceps surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

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

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

1 day

1 visit (in-person)

Post-operative Imaging

X-ray imaging is conducted in the post-anesthesia care unit to determine a baseline measurement of the radiolucent bead location.

1 day

1 visit (in-person)

Follow-up

Participants undergo further x-ray imaging and report outcomes at 2-week and 6-month follow-up visits.

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• One Anchor
• Two Mini Anchors

Trial Overview

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.

How Is the Trial Designed?

Group I: Two Mini Anchors Experimental Treatment 1 Intervention

Participant will receive two mini anchors during standard biceps tenodesis procedure

Group II: One Anchor Experimental Treatment 1 Intervention

Participant will receive one standard anchor during standard biceps tenodesis procedure

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a study of 28 patients who underwent shoulder arthroscopic procedures, complications such as loose and prominent metal anchors were identified, primarily affecting those treated for anterior traumatic instability.

The findings suggest that these complications often arise from inappropriate surgical techniques, highlighting the importance of proper methods in arthroscopic procedures to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COMPLICATIONS RESULTING FROM THE USE OF METAL ANCHORS IN SHOULDER ARTHROSCOPY. Godinho, GG., França, FO., Alves Freitas, JM., et al.[2020]

In a study of 288,250 shoulder arthroscopic procedures, the overall rate of serious complications within 90 days was low at 1.2%, with pneumonia being the most common adverse event at 0.3%.

The rate of reoperation within one year was 3.8%, indicating that while serious adverse events are infrequent, there is still a notable risk of needing further surgery, particularly after certain procedures like frozen shoulder release.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse event rates and reoperation after arthroscopic shoulder surgery: population based cohort study. Rees, JL., Craig, R., Nagra, N., et al.[2022]

In a study involving 120 patients undergoing arthroscopic rotator cuff repair, the all-suture anchor demonstrated equivalent clinical performance to the established solid suture anchor, with no significant differences in Constant-Murley scores at the 12-month follow-up.

The retear rates for both anchors were similar, with 5.7% for the all-suture anchor and 1.9% for the solid anchor, indicating that the all-suture anchor is a safe and effective alternative for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An All-Suture Anchor Offers Equivalent Clinical Performance to an Established Solid Suture Anchor in the Arthroscopic Repair of Rotator Cuff Tears: A Prospective, Randomized, Multicenter Trial With 12-Month Follow-Up. Yan, H., Zhao, L., Wang, J., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7551489/

Clinical Outcomes of an All-Arthroscopic Biceps Tenodesis ...

The introduced technique results in a high rate of patient satisfaction, with significant improvement in shoulder outcome scores and decreased ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1058274613002814

Clinical and radiologic results of arthroscopic biceps ...

Arthroscopic biceps tenodesis with 1 suture anchor resulted in good clinical outcomes at 2 years postoperatively. PD was seen in 12.9% of the patients.

3.

arthroscopytechniques.org

arthroscopytechniques.org/article/S2212-6287(22)00111-6/fulltext

Single Medial-Row Anchor With Biceps Tenodesis in a ...

This technique simplifies the fixation of a massive rotator cuff tear and also reinforces the repair with the biceps tendon.

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/os.14198

Clinical Outcome of an All Arthroscopic 'Whole Layer' ...

The procedure revealed a satisfactory functional outcome, reduced pain, and minimal complications and reoperations.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5127942/

Outcomes following long head of biceps tendon tenodesis

All 13 patients with an average 13 months of follow-up demonstrated significant clinical improvement in both ASES and SST scores [62]. None of ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10993671/

Sports and Clinical Results After All-Arthroscopic Biceps ...

Tenodesis of the LHBT with a 2.7-mm knotless anchor resulted in good clinical outcomes with a high return-to-sports rate (100%), even with ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666638324001087

Biceps tenotomy vs. tenodesis: an ACS-NSQIP analysis of ...

Of serious adverse events, tenotomy patients experienced a higher rate of death (0.38%) as compared to tenodesis patients (0%). Similar to the present study's ...

8.

arthroscopysportsmedicineandrehabilitation.org

arthroscopysportsmedicineandrehabilitation.org/article/S2666-061X(24)00038-5/fulltext

Combined, Single-Anchor Subscapularis Tendon Repair ...

Patients treated with combined, single-anchor SST repair and LNT proximal biceps tenodesis achieved significant improvements in function, high satisfaction, ...

9.

journals.lww.com

journals.lww.com/jotr/fulltext/2022/14010/the_safety_and_efficacy_of_biceps_tenodesis.8.aspx

The Safety and Efficacy of Biceps Tenodesis Performed ...

In this retrospective case series of 29 patients undergoing biceps tenodesis, there was a 6.9% complication rate observed in the first 6 months postoperatively.

10.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06815796

Loop Vs. Anchor Tenodesis of the Long Head of the Biceps ...

It will also assess the safety and outcomes of both techniques. The main questions it aims to answer are: How effective is loop tenodesis compared to suture ...