Embolization for Rotator Cuff Injury

(ELECTRC Trial)

Overseen By Yan Epelboym, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Peripheral arterial disease, Anaphylaxis to contrast, Renal dysfunction, Pregnancy, Prior shoulder surgery, others

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

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

41 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized controlled trial in which patients with moderate to severe shoulder pain (Visual Analog Scale (VAS) \> 40), in the setting of rotator cuff tendinopathy refractory to conservative treatment, will be enrolled. The primary aim of the study is to estimate the effect of transcatheter arterial embolization (TAE) with physical therapy (PT) vs PT alone on the change in shoulder pain at 12-month follow up. Scientific objectives also include an assessment of safety of the intervention, assessment of changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity score, Shoulder Pain and Disability Index (SPADI) scores, MRI Tendinopathy Score between the TAE + PT and PT groups.

Do I need to stop 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.

Is embolization generally safe for humans?

The research articles reviewed do not provide specific safety data on embolization for rotator cuff injuries or similar procedures. Therefore, no relevant safety information is available from these sources. ^{1 2 3 4 5}

How does embolization differ from other treatments for rotator cuff injury?

Embolization is unique because it involves blocking blood vessels to reduce inflammation and pain, unlike other treatments like injections or surgical repairs that directly target the tendon or use substances like corticosteroids or platelet-rich plasma to promote healing. ^{6 7 8 9 10}

Research Team

Yan Epelboym, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults with moderate to severe shoulder pain from rotator cuff tendinopathy that hasn't improved after at least 6 months of treatment, including painkillers, injections, or physical therapy. Participants must be able to give informed consent and undergo angiography and physical therapy.

Inclusion Criteria

I experience moderate to severe shoulder pain.

My pain hasn't improved after 6 months of treatment, including 6 weeks of physical therapy.

My gender identity is inclusive of male, female, transgender, or non-binary.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either transcatheter arterial embolization (TAE) with physical therapy or physical therapy alone for 3 months

12 weeks

4 visits (in-person) at week 0, week 4, week 8, and week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 3, 6, and 12 months

12 months

4 visits (in-person or virtual) at 1, 3, 6, and 12 months

Treatment Details

Interventions

• Embolization

Trial Overview The study compares the effectiveness of transcatheter arterial embolization (TAE) combined with physical therapy (PT) versus PT alone in reducing shoulder pain over a period of 12 months. It also evaluates safety and changes in function and disability scores.

Participant Groups

Group I: Embolization Experimental Treatment 2 Interventions

Angiography will be performed to identify hyperemic neovasculature arising from one or more of branch shoulder arteries. After localizing the abnormal neovessels a microcatheter will be inserted coaxially and selectively placed in the targeted artery(ies). The abnormal vessels will be embolized with Lipiodol emulsion (Guerbet, Villepinte, France) The embolic agent will be used under an investigational device exemption from the FDA. The embolic will be injected in small volume increments until blood flow stagnates in the target artery(ies). Angiography and embolization will be repeated until the hyperemia is markedly reduced as demonstrated on digital subtraction angiography. Subjects will participate in structured physical therapy consisting of 3 months of eccentric strength training. This twelve-week program will consist of 4 PT sessions at week 0, week 4, week 8, and week 12.

Group II: Physical Therapy Active Control 1 Intervention

Subjects will participate in structured physical therapy consisting of 3 months of eccentric strength training. This twelve-week program will consist of 4 PT sessions at week 0, week 4, week 8, and week 12.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Findings from Research

A total of 497 adverse events related to synthetic male slings were reported to the FDA from 2009 to 2018, with the majority classified as injuries (95.4%) and the most common issues being urinary incontinence (46.7%) and sling erosion (9.1%).

Despite concerns surrounding urogynecologic mesh, there was no significant increase in adverse event reports for male slings following FDA warnings, indicating that the controversy did not impact reporting rates, highlighting the need for further clinical studies to assess safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database. Zhao, H., Souders, CP., Kuhlmann, PK., et al.[2021]

A study analyzing 60 reports from the FDA's MAUDE database on radiofrequency ablation (RFA) for leiomyomas found that the most common adverse event was infection, highlighting potential safety concerns with this treatment.

Of the injury cases reviewed, 34.9% required additional surgical intervention, indicating that while RFA is a novel treatment option, there are significant risks that necessitate careful monitoring and postmarket surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency Ablation for Treatment of Leiomyomas: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database. Young, RJ., Puma, L., Latham, M., et al.[2023]

A retrospective analysis of the MAUDE database from 2004 to 2014 revealed 9 deaths and 215 injury events linked to electromechanical morcellation, highlighting significant risks associated with this surgical device.

The analysis found that 27 cases involved the morcellation of previously undiagnosed cancers, with 8 of the 9 deaths related to cancer morcellation, indicating a critical safety concern in using these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of Electromechanical Morcellation Reported in the Manufacturer and User Facility Device Experience (MAUDE) Database. Naumann, RW., Brown, J.[2019]

A comprehensive analysis of 7,766,737 adverse event records from the FDA's MAUDE database revealed that 96.6% of reports came from manufacturers, highlighting a significant reliance on manufacturers for safety data.

Patient and nurse reports to the FDA were much more common than physician reports, with only 0.49% of physician reports submitted directly, indicating a need for improved physician engagement in reporting adverse events to enhance post-market surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporter's occupation and source of adverse device event reports contained in the FDA's MAUDE database. Kavanagh, KT., Brown, RE., Kraman, SS., et al.[2022]

Thromboembolic events are the most common adverse occurrences in endovascular neurosurgery, with incidence rates varying from 2% to 61%, highlighting the need for effective prevention strategies, although optimal use of anticoagulants remains unclear.

Groin-site hematomas are the most frequent access-related complications, with an incidence of 9% to 32%, and there is a lack of standardized protocols for prevention, indicating a need for systematic guidelines to improve safety in neurosurgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns in neurosurgical adverse events: endovascular neurosurgery. Wong, JM., Ziewacz, JE., Panchmatia, JR., et al.[2012]

In a study involving 28 rats with rotator cuff injuries, using a cannulated humeral implant to deliver local bone marrow did not significantly improve tendon-to-bone healing compared to a solid implant.

While there was evidence of intraluminal bone growth in the cannulated implants, the small size of the rat models may have limited the effectiveness of bone marrow delivery, suggesting that further research in larger animals is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rotator cuff repair augmentation with local autogenous bone marrow via humeral cannulation in a rat model. Levy, DM., Saifi, C., Perri, JL., et al.[2016]

A study involving 60 patients with rotator cuff disease found that allogeneic platelet-rich plasma (PRP) injections are safe and do not lead to treatment-related adverse events.

While PRP injections did not show immediate superiority over corticosteroid injections in pain relief, they resulted in significantly better long-term outcomes in terms of overall function and external rotation at 6 months, indicating a gradual improvement in shoulder function compared to the quicker but less sustained response from corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial. Jo, CH., Lee, SY., Yoon, KS., et al.[2021]

This systematic review and meta-analysis aims to evaluate the effectiveness of various substances used in subacromial injections for treating rotator cuff injuries and shoulder impingement syndrome, focusing on pain relief and functional improvement.

The study will analyze data from multiple databases and assess the quality of included studies, ensuring a comprehensive understanding of the therapeutic options available for these shoulder conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of subacromial injections in rotator cuff lesions: systematic review and meta-analysis protocol. Tossolini Goulart, L., Matsunaga, FT., Belloti, JC., et al.[2022]

Triamcinolone acetonide (TAA) treatment in isolated human rotator cuff tendon cells led to significant cellular degeneration, reduced collagen I production, and decreased cell proliferation, which may impair tendon healing.

The study suggests that TAA may contribute to weaker tendon properties and a higher risk of re-rupture after rotator cuff repairs, highlighting potential safety concerns with glucocorticoid injections in treating shoulder injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of crystalline glucocorticoid triamcinolone acetonide on cultered human supraspinatus tendon cells. Tempfer, H., Gehwolf, R., Lehner, C., et al.[2022]

The refined 'SCOI Row' technique for rotator cuff repair, utilizing a single row of triple-loaded anchors, has shown over 90% healing rates on postoperative MRI and excellent patient-reported outcomes, indicating its efficacy.

The technique enhances biological healing through the creation of bone marrow vents, which deliver growth factors and cells to the repair site, improving the chances of successful tendon regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Row Rotator Cuff Repair with Triple Loaded Suture Anchors: The SCOI Row Technique. Arroyo, W., Getelman, MH., Snyder, SJ.[2021]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database. [2021]

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

Radiofrequency Ablation for Treatment of Leiomyomas: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database. [2023]

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

Complications of Electromechanical Morcellation Reported in the Manufacturer and User Facility Device Experience (MAUDE) Database. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Reporter's occupation and source of adverse device event reports contained in the FDA's MAUDE database. [2022]

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

Patterns in neurosurgical adverse events: endovascular neurosurgery. [2012]

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

Rotator cuff repair augmentation with local autogenous bone marrow via humeral cannulation in a rat model. [2016]

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

Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Effectiveness of subacromial injections in rotator cuff lesions: systematic review and meta-analysis protocol. [2022]

9. Sweden pubmed.ncbi.nlm.nih.gov

Effects of crystalline glucocorticoid triamcinolone acetonide on cultered human supraspinatus tendon cells. [2022]

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

Single Row Rotator Cuff Repair with Triple Loaded Suture Anchors: The SCOI Row Technique. [2021]