The proposed study addresses the significant health care need of providing a new non-narcotic therapy to relieve pain, reduce opioid use, and improve recovery following surgeries involving orthopaedic trauma by evaluating the use of a minimally invasive medical device. The device is a percutaneous peripheral nerve stimulation (PNS) system designed to manage post-operative pain, eliminate or reduce opioid use, and accelerate functional rehabilitation in military Service members, Veterans, their families, and other military health system beneficiaries in response to the fiscal year 2017 Peer Reviewed Orthopaedic Research Program Focus Area of “Post-Operative Pain Management.”

Objectives and Rationale: The objective of the proposed study is to improve management of pain following surgeries (also called post-operative pain) involving orthopaedic trauma. Orthopaedic traumas and their long-term effects, like osteoarthritis, are among the most common combat injury-related disqualifying conditions. Injuries caused by orthopaedic trauma and the surgeries to repair or treat this condition can cause substantial, long-lasting pain. Orthopaedic procedures, especially after musculoskeletal injury, have high rates of long-lasting pain after surgery, extended opioid usage, and prolonged rehabilitation recovery periods; individuals often experience significant levels of disability following orthopaedic surgeries.

The proposed study is a Phase II randomized controlled trial (RCT) that will test the ability of the percutaneous PNS system to manage post-operative pain, eliminate or reduce opioid use, and accelerate return to normal activity through rehabilitation. The study will focus on surgery for combat and non-combat related orthopaedic trauma. If pain is controlled, surgeries following orthopaedic trauma can have a high long-term success rate. However, post-operative pain is often severe and long-lasting, resulting in prolonged opioid use and delayed functional recovery, which increases the risk for opioid misuse, chronic pain, long-term disability, separation from duty, and impacts to military unit readiness. The proposed study will evaluate the PNS treatment in one of the most painful, commonly performed, standard orthopaedic procedures that exemplifies the challenges with post-operative pain, opioid use, and functional recovery that are common to many orthopaedic traumas. The primary goal is to test and make available to the U.S. military a safe and effective non-opioid treatment for post-operative pain following orthopaedic trauma that will facilitate physical rehabilitation and improve functional recovery.

Applicability: The proposed study is a Phase II RCT to determine whether a non-opioid pain management therapy utilizing percutaneous PNS can relieve post-operative pain, reduce opioid use, and improve function following orthopaedic trauma in a target study population that is representative of other military patients undergoing surgery for combat- and non-combat-related orthopaedic injuries. The proposed study’s design is based on promising results from previous Phase I feasibility studies, which demonstrated that percutaneous PNS can produce immediate clinically significant reductions in postoperative pain, reduce opioid use, and accelerate functional recovery in a majority of patients. The non-opioid, minimally invasive therapy to be studied in this research has already been tested in multiple clinical studies. With stimulation therapy, study participants reported clinically significant reductions in pain and improvements in function, with only minor temporary side effects (such as skin irritation under the bandage and bruising or tissue damage, which were healed).

Timeline: Previous studies suggest percutaneous PNS will have an immediate impact (as early as day 1 after surgery) on patient outcomes in study participants who receive the usual standard of care (SOC) plus active PNS. Study participants who receive SOC plus placebo PNS will cross over to receive active PNS midway through the study, and a third group will receive SOC only. The proposed Phase II study will be completed in 4 years and will produce safety and effectiveness data to support a pivotal (Phase III) study. The resulting data will support Food and Drug Administration 510(k) clearance for management of post-operative pain and reduction of opioid usage following orthopaedic surgeries and enable the commercial system to be provided to the military, Veterans, and civilians.

Military Benefit: The proposed study supports the U.S. military’s interest in improving post-operative pain management to reduce opioid use and improve functional recovery following traumatic orthopaedic injuries. Traumatic orthopaedic injuries represent a serious burden on the Military Health System, as they are a significant problem in military and Veteran populations, are the cause of many disabling conditions, and result in the highest rate of separation from duty. Management of pain, opioid cessation, and functional recovery are critical to enabling Service members to return to duty and maintaining unit readiness following non-battle orthopaedic injuries. The proposed study will directly address pain relief, opioid use, and function in the target study population. If successful, the proposed study will significantly improve patient care for military Service members, Veterans, their families, and civilians with traumatic orthopaedic injuries who require surgery.