NCT03339492

PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears

Prospective, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Pulsed Electromagnetic Field (PEMF) Therapy as an Adjunctive Treatment to Surgical Repair of Full Thickness Rotator Cuff Tears

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: Orthofix Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to prospectively determine, at 12 months post-surgical repair of full thickness rotator cuff tears, the safety and efficacy of treating full thickness rotator cuff repairs with pulsed electromagnetic fields (PEMF). The hypothesis states that exposure to a pulsed electromagnetic field (PEMF) following surgical repair of a full thickness rotator cuff tendon tear reduces tendon re-tear rates. The strength of the shoulder muscles and the levels of pain in subjects after surgical repair of their rotator cuff adjunctively treated with an active PEMF device will also be measured.

Detailed description

This Clinical Investigation Plan (CIP) describes the prospective, randomized, double-blind, placebo controlled study to evaluate the safety and efficacy of Pulsed Electromagnetic Field (PEMF) therapy as an adjunctive treatment to surgical repair of full thickness rotator cuff tears. Rotator cuff tears are common musculoskeletal injuries which often require surgical intervention. Unfortunately, post-repair prognosis is poor, and surgical repairs have been reported to fail in up to 94% of cases (Galatz et. al., 2004). Repaired tissue tends to be fibrotic, disorganized, and reattaches poorly to the bony insertion. To improve tendon-to-bone healing, many non-invasive therapeutic devices have been utilized post-operatively including therapeutic ultrasound and shock wave therapy (Lovric et. al., 2013; Springer and Badgett, 2015). In orthopedics, the use of these non-invasive therapeutic devices has become increasingly popular during the post-operative recovery period in an effort to enhance tissue healing. These devices are relatively inexpensive and easily obtainable and relatively easy to use, and are especially enticing as they can be brought into the patient's home and do not require frequent visits to the clinic. Additionally, non-invasive therapeutic devices can be used for a variety of applications, including promoting tissue healing prior to surgical intervention or in lieu of surgical intervention all together. Although there are numerous advantages to using non-invasive therapeutic devices, their efficacy has not yet been maximized. Based on the pre-clinical work presented (Tucker et. al., 2016; Huegel et. al., 2017), it is believed that pulsed electromagnetic fields may be an effective adjunctive treatment for patients who have undergone surgical repair of a torn rotator cuff.

Conditions

• Full-thickness Rotator Cuff Tear

Interventions

Type	Name	Description
DEVICE	RCStim Model 1114	Active device emits PEMF signal; placebo/control device does not emit PEMF signal

Timeline

• Start date: 2018-01-15
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2017-11-13
• Last updated: 2023-08-30

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated device study