Embolization for Rotator Cuff Injury
(ELECTRC Trial)
Recruiting in Palo Alto (17 mi)
Overseen byYan Epelboym, MD, MPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Brigham and Women's Hospital
Disqualifiers: Peripheral arterial disease, Anaphylaxis to contrast, Renal dysfunction, Pregnancy, Prior shoulder surgery, others
No Placebo Group
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.
12345How 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.
678910Eligibility 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.
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: EmbolizationExperimental Treatment2 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 TherapyActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Brigham and Women's HospitalLead Sponsor
References
Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database. [2021]We sought to describe and analyze the adverse events associated with synthetic male slings reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.
Radiofrequency Ablation for Treatment of Leiomyomas: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database. [2023]Radiofrequency ablation (RFA) is a relatively novel, increasingly popular treatment option for leiomyomas. We studied medical device-related reports of leiomyoma RFA devices to determine whether there are emerging device-related issues. The Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried from 2012 through November 2022. Sixty unique reports, including adverse events and device malfunctions, were analyzed for both laparoscopic and transcervical RFA devices. Forty-three injury reports were reviewed. The most common adverse event was infection. Of the injury cases, 34.9% required additional surgical intervention. Although the details of each event are limited, these reports highlight the importance of postmarket surveillance of new technologies and the necessity of improving the current system of implementation and monitoring.
Complications of Electromechanical Morcellation Reported in the Manufacturer and User Facility Device Experience (MAUDE) Database. [2019]To evaluate adverse events associated with electromechanical morcellation as reported to the Manufacturer and User Facility Device Experience (MAUDE) database.
Reporter's occupation and source of adverse device event reports contained in the FDA's MAUDE database. [2022]A review of the medical device adverse events submitted to the United States Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was undertaken to determine the major sources of the information.
Patterns in neurosurgical adverse events: endovascular neurosurgery. [2012]As part of a project to devise evidence-based safety interventions for specialty surgery, the authors sought to review current evidence in endovascular neurosurgery concerning the frequency of adverse events in practice, their patterns, and current methods of reducing the occurrence of these events. This review represents part of a series of papers written to consolidate information about these events and preventive measures as part of an ongoing effort to ascertain the utility of devising system-wide policies and safety tools to improve neurosurgical practice. Based on a review of the literature, thromboembolic events appeared to be the most common adverse events in endovascular neurosurgery, with a reported incidence ranging from 2% to 61% depending on aneurysm rupture status and mode of detection of the event. Intraprocedural and periprocedural prevention and rescue regimens are advocated to minimize this risk; however, evidence on the optimal use of anticoagulant and antithrombotic agents is limited. Furthermore, it is unknown what proportion of eligible patients receive any prophylactic treatment. Groin-site hematoma is the most common access-related complication. Data from the cardiac literature indicate an overall incidence of 9% to 32%, but data specific to neuroendovascular therapy are scant. Manual compression, compression adjuncts, and closure devices are used with varying rates of success, but no standardized protocols have been tested on a broad scale. Contrast-induced nephropathy is one of the more common causes of hospital-acquired renal insufficiency, with an incidence of 30% in high-risk patients after contrast administration. Evidence from medical fields supports the use of various preventive strategies. Intraprocedural vessel rupture is infrequent, with the reported incidence ranging from 1% to 9%, but it is potentially devastating. Improvements in device technology combined with proper endovascular technique play an important role in reducing this risk. Occasionally, anatomical or technical difficulties preclude treatment of the lesion of interest. Reports of such occurrences are scant, but existing series suggest an incidence of 4% to 6%. Management strategies for radiation-induced effects are also discussed. The incidence rates are unknown, but protective techniques have been demonstrated. Many of these complications have strategies that appear effective in reducing their risk of occurrence, but development and evaluation of systematic guidelines and protocols have been widely lacking. Furthermore, there has been little monitoring of levels of adherence to potentially effective practices. Protocols and monitoring programs to support integrated implementation may be broadly effective.
Rotator cuff repair augmentation with local autogenous bone marrow via humeral cannulation in a rat model. [2016]Growth factors have been shown to improve healing after rotator cuff repair. Bone marrow is a potential vehicle for growth factor augmentation, yet methods of delivering marrow to cuff repair sites are still under-researched. We hypothesized that a cannulated humeral implant would deliver local bone marrow and thereby improve healing in a rat model.
Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial. [2021]The use of platelet-rich plasma (PRP) for the treatment of rotator cuff disease is still controversial. The purpose of the present study was to investigate the safety and efficacy of a fully characterized allogeneic pure PRP injection into the subacromial space of patients with rotator cuff disease in comparison with corticosteroid injection.
Effectiveness of subacromial injections in rotator cuff lesions: systematic review and meta-analysis protocol. [2022]Subacromial injections are therapeutic options for rotator cuff injuries, with consistent results not well established yet for each drug applied. The objective of this systematic review and meta-analysis is to analyse the effectiveness of the substances used in subacromial injections for the treatment of rotator cuff injuries and shoulder impingement syndrome, considering the functional gain and pain improvement of the shoulder.
Effects of crystalline glucocorticoid triamcinolone acetonide on cultered human supraspinatus tendon cells. [2022]Rotator cuff tears are a common cause of shoulder pain and impairment. Subacromial glucocorticoid injections are widely used for treatment of epiphenomenons of chronic impingement syndrome with the possible side effects of tendon rupture and impaired tendon healing.
Single Row Rotator Cuff Repair with Triple Loaded Suture Anchors: The SCOI Row Technique. [2021]Since the introduction of rotator cuff repair in the beginning of the 20th century, there have been significant advances in the surgical techniques and improvement in patient outcomes. However, controversy remains regarding the best method for tendon repair, including implant choice, ideal suture construct, and the potential benefits of supplemental biologic additives in order to achieve repair with the best opportunity for healing. The "SCOI Row" technique has been refined over three decades with extensive application and consistently good outcomes. Our technique uses a single row of anchors, triple loaded with a high-strength suture maximizing the number of sutures passed through the tendon to repair the rotator cuff arthroscopically. These anchors are placed 3-4 millimeters from the articular cartilage, providing strong anchorage and a low-tension repair. Debridement of devitalized tendon and only incorporating healthy tendon into the repair is imperative. The biology of the repair is enhanced with bone marrow vents created via microfracture of the greater tuberosity, forming the "Crimson Duvet" or bone marrow super-clot that will envelope the repair site. The bone marrow vents deliver marrow elements, including growth factors and mesenchymal cells that will help to regenerate the footprint of the rotator cuff. This repair construct has been evaluated biomechanically by other investigators and is favorable, as compared to dual row repairs. Our outcomes show greater than 90 % healing rate on postoperative magnetic resonance imaging and excellent patient-reported outcomes.