PI: Ray

Protocol ID: SC180063

Short study title: Peripheral Nerve Transfer Surgery to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients

Sponsor:  Department of Defense

Short description: It is estimated that greater than 250,000 Americans are living with spinal cord injury (SCI). Recovery from complete SCI is exceedingly rare, leaving most patients with permanent and significant disability. More than half of SCI occurs in the cervical spine resulting in tetraplegia. Patients with tetraplegia are dependent upon and remaining arm and/or hand function to perform functions of daily living including feeding, writing, self-transfers, and self-catheterization. Hand function, especially, is important for quality of life and recovering even partial arm and hand function after injury can result in an enormous positive impact. Peripheral nerve transfer surgeries have been increasingly utilized to treat nerve injuries, and offers a promising alternative to another well-known and widely utilized technique, tendon transfer surgery. Peripheral nerve transfer surgery may offer several advantages to tendon transfer surgery, including improving hand function in patients who may not receive any benefit after tendon transfer, maintaining biomechanics without sacrifice of function in other muscles, and not requiring prolonged immobilization. The surgery takes place in the patient’s arm.  A nerve originating from above the SCI is transferred to a nerve that originates below the injury.  This nerve is still intact, but it cannot receive the message from the brain due to the SCI. The goal of surgery is to help improve hand and/or arm function in patients with tetraplegia allowing them to be more independent in daily activities. Our group has published several case series demonstrating functional improvements provided by nerve transfers in patients with cervical SCIs. However, the optimal timing of peripheral nerve transfers, patient selection, and long-term outcomes are not well-defined even in large meta-analyses. There is a need to enroll patients and to closely follow their progress over time to better define these important factors for patients with cervical SCI with tetraplegia to help guide future clinical trials.  Participants will have a portion of their outpatient weekly therapy paid for through the Department of Defense grant.

Key eligibility criteria:

  • Diagnosis of ASIA A or B tetraplegia (SCI level C4 through C8)
  • Any sex, age 18 through 65
  • At least 3 months of non-operative rehab therapy with no improvement
  • Cervical SCI occurred within last 36 months
  • Electromyogram and nerve conduction studies (EMG/NCS) with intact innervation to muscles below level of injury
  • Excludes: significant joint contractures, prior tendon transfer surgery (or planning to under tendon transfer during the study period), active system infection or infection at operative site, immunosuppressed, taking long-term steroids, active cancer, pregnancy

Contact person: Linda Koester, 314-362-7368, koesterl@wustl.edu

Enrollment period: October 2020 – current

PI: Ray

Protocol ID: 202012139

Short study title: Developing a Future in Personalized Medicine in Spine Surgery (EMA)

Short description: Ecological Momentary Assessment (EMA) is a brief survey used to monitor important signs of a patient’s quality of life before and after spine surgery. These factors include pain, disability, and psychosocial health. Tracking this information over time can generate data to help to improve personalized medicine for future patients. The EMA can be quickly and easily completed using a mobile phone, and participants will also be offered a wearable fitness tracker. The goal of the study is for patients to complete the survey 5 times per day for 3 weeks before the upcoming surgery and once per night, starting 5 days after surgery and continuing for 26 days.

Key eligibility criteria:

  • Any sex, age 21 through 85
  • Has access to a smartphone and can complete surveys
  • Has degenerative spine disease and will undergo spine surgery (fusion included)
  • Excludes: active spine infection and/or spine cancer, patients undergoing surgery for acute spinal trauma

Other information:

  • Patients may be recruited in person while at spine clinic, over the phone, or through Zoom
  • Monetary compensation will be provided for patients after each stage of the study

A research coordinator will identify and contact potential candidates.

Enrollment period: December 2020- Current

PI: Ray

Protocol ID: ERAS protocol 1.0

Short study title: Rapid Recovery after Minimally-Invasive Spine Surgery

Short description: The Enhanced Recovery After Surgery (ERAS) program is a “fast-track” program designed to speed recovery after minimally-invasive spine (MIS) surgery. It is geared towards providing patients who are highly motivated to return to a higher quality of life an option to minimize the hospital stay and speed recovery by encouraging early mobility and initiating appropriate rehabilitation. There is an emphasis on patient education and the importance of setting realistic expectations after surgery in order to maximize recovery. Patients will be highly encouraged to undergo at least 1 session of outpatient physical therapy prior to surgery where they will be instructed on strengthening, mobility, and rehabilitation exercises to be performed after surgery. A multidisciplinary team of nurses, advanced practitioners, physicians, and therapists will work with the patient to help achieve their goal.

Key eligibility criteria:

  • Patients offered elective spine surgeries including: MIS-TLIF, ALIF, OLIF, and MIS decompressions
  • Transportation home and a caregiver near home for 48h after hospital discharge
  • Excludes: tobacco use, chronic opioid use

Other information:

  • Patients are recruited by surgeons during preoperative clinic visits

A research coordinator will identify and contact potential candidates. 

Enrollment period: June 2020 – Current

PI: Molina 

Protocol ID: 202107045 

Short study title: Activity Tracker for Patients undergoing Spine Surgery 

Short description: Commercial wearable systems such as Nike+, FitBit, and Apple Watch are becoming increasingly more popular to track daily information related to walking, working, eating, and sleeping. The ease-of-use is partly due to the small size and light weight nature of the accelerometers, gyroscopes, and magnetometers used in these devices. Although more and more people are incorporating wearable systems into their daily lives, the clinical applications are largely unexplored. These devices could provide important information to improve patient care and outcomes. The goal of this study is to understand the effect of spine surgery on patients function through the analysis of continuous activity assessment measured by commercial wearable systems.  

Key eligibility criteria

  • Age 18 and up  
  • Has access to an iPhone and an Apple Watch and can complete surveys. The study is currently limited to iOS® compatible devices. 
  • The patient will undergo spine surgery 
  • Excludes: Any patient in whom at least a 2-week pre-operative data collection is not possible (e.g., due to the urgency / emergency of the surgical intervention) 

Other information

  • Patients may be recruited in person while at spine clinic, over the phone, or through Zoom 

Contact person: Miguel Ruiz Cardozo, 314-362-3649, miguelr@wustl.edu

Enrollment period: July 30, 2021 – July 2023

PI: Ray and Molina

Short study title: Augmedics XVision Surgical Navigation System

Short description: In recent years, spine surgery has been increasingly been performed with the assistance of computer-navigation and robotics, which may increase accuracy of hardware placement and reduce inadvertent injury. In general, these systems have proved to be extremely safe. However, several drawbacks have been reported, including line-of-sight interruptions and attention shift. A new technology, Augmedics XVision Surgical Navigation System, is a 3D augmented-reality headset that the surgeon wears in order to integrate all intraoperative imaging into a real-time stereoscopic 3D image of the patient’s anatomy. As such, it addresses the drawback of a surgeon needing to look away from the patient in order to view intraoperative imaging. Our previous cadaveric study demonstrated a 96.7% open and 98.9% percutaneous pedicle screw placement accuracy with Augmedics, which was shown to be non-inferior to robotic-assisted computer-navigated information and superior to conventional, fluoroscopically-guided manual placement of pedicle screws. The aim of this study is to evaluate the accuracy of pedicle screw placement by the Augmedics XVision Surgical Navigation System and report on outcomes. This technology has the potential to revolutionize spine surgery and improve safety for patients undergoing spine surgery.

Key eligibility criteria:

  • Age 18 and up
  • Patients scheduled to undergo spine surgery with pedicle screw insertion with the use of the XVS headset

Patients will be enrolled at the discretion of the treating physician

Enrollment period: June 2020 – Current