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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment One Anchor, Two Mini Anchors for shoulder impingement?

Research on similar treatments, like the use of suture anchors for shoulder injuries, shows that they can effectively stabilize the shoulder and improve function. Studies have found that using multiple anchors can enhance shoulder stability, although it might slightly reduce the range of motion. ^{1 2 3 4 5}

Is the use of suture anchors in shoulder surgery generally safe?

Research shows that suture anchors, including metal and all-suture types, are generally safe for shoulder surgeries, with no metal-related complications found at a 2-year follow-up and equivalent safety to traditional methods in a 12-month study. ^{2 6 7 8 9}

How does the One Anchor, Two Mini Anchors treatment for shoulder impingement differ from other treatments?

The One Anchor, Two Mini Anchors treatment is unique because it uses a combination of one main anchor and two smaller anchors to stabilize the shoulder, potentially offering a more secure and tailored repair compared to traditional single anchor methods. This approach may provide better support and healing for shoulder impingement by addressing specific structural issues. ^{1 10 11 12 13}

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.

Research Team

Michael Freehill, MD

Principal Investigator

Stanford University

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Effectiveness of a single threaded anchor fixation under shoulder arthroscopy in treatment of fresh bony Bankart injury]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Cyclic and Load-to-Failure Properties of All-Suture Anchors in Human Cadaveric Shoulder Glenoid Bone. [2020]

3. China pubmed.ncbi.nlm.nih.gov

[Curative effect of arthroscopic suture anchor fixation on shoulder bankart injury]. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Bankart Repair With Remplissage Restores Better Shoulder Stability Than Bankart Repair Alone, and Medial or Two Remplissage Anchors Increase Stability but Decrease Range of Motion: A Finite Element Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The histologic and biomechanical response of two commercially available small glenoid anchors for use in labral repairs. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Serious adverse event rates and reoperation after arthroscopic shoulder surgery: population based cohort study. [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

COMPLICATIONS RESULTING FROM THE USE OF METAL ANCHORS IN SHOULDER ARTHROSCOPY. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Use of Mitek anchoring for Bankart repair: A comparative, randomized, prospective study with traditional bone sutures. [2022]

9. United States 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. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

[Quality of post-operative pain therapy after subacromial decompression of the shoulder with resection of the lateral clavicula by arthroscopy]. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Arthroscopic separate labral repair and capsular plication with a suture anchor. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

[Lifting osteotomy of the acromion as a new principle in treatment of impingement syndrome, especially in correlation with reconstruction of large rotator cuff lesions]. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Acromiohumeral distance and supraspinatus tendon thickness in people with shoulder impingement syndrome compared to asymptomatic age and gender-matched participants: a case control study. [2021]