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Center for Disruptive Musculoskeletal Innovations (CDMI)

Northeastern University

The Ohio State University

University of California, San Francisco

University of Toledo

Last Reviewed: 06/24/2019

The Center for Disruptive Musculoskeletal Innovations (CDMI) represents an exciting and novel integration of healthcare economics, biomedical science and clinical medicine. University faculty and industry partners are able to collaborate to target novel technologies that will decrease healthcare costs and improve the management and life of patients with musculoskeletal disease.

Center Mission and Rationale

Mission:

The mission of the CDMI is to identify unmet market needs and address these with fundamental musculoskeletal research on:

  • Clinical outcomes and cost data
  • Implant materials
  • Tissue engineering
  • Biosensors
  • Evaluation of surgical techniques
  • Non-invasive diagnostic/preventative technologies

 

Rationale:

Current debates and policies surrounding healthcare create an acute conflict between the need for medical cost containment and our nation’s commitment to foster technological innovations that improve human health. Approximately 40-50% of healthcare expenses can be traced to the adoption of new technologies or the intensified use of old ones. Consequently, the control of technology is arguably the single most important factor for managing healthcare costs. As a result, third-party payors are giving ever-increasing attention to medical devices in their coverage decisions, with a growing focus on authorizing the use of medical technology only on those patient segments where it truly adds value. Unfortunately, without confidence that a new medical technology will be reimbursed, it is increasingly difficult to justify the investment required to bring that technology to market. This creates a significant deterrent to innovation, and places America’s leadership position in medical technology in jeopardy. More importantly, these trends negatively impact the opportunities for patients to experience the life-enhancing benefits of technologies that are never developed into products that can be brought to market. Therefore, there is a pressing societal need to create more value from the money spent on medical technology, and thereby manage healthcare costs without sacrificing the benefits of innovation.

Research program

BIOMECHANICS

Biomechanical Investigation of Exoskeletons for Low Back Support

Exoskeletons are countermeasures that have the potential to reduce the risk of occupational injuries and increase worker productivity.  Various exoskeletons are commercially available, but relatively few studies have examined their benefits or, more importantly, their potential drawbacks.  The objective of this study is to evaluate the biomechanical loads on the spines of subjects using two commercially available exoskeletons designed for low back support while performing realistic occupational exertions.

​Principal Investigator: William Marras, PhD

Trainee: Greg Knapik

Development of a Protocol to Evaluate Growth Rods in a Missing Vertebra Model

The original F1717 (FDA) and ISO 12189 protocols were designed with an intent for testing spinal devices, Figure 1A, B and C. These guidelines were modified to accommodate evaluation of posterior dynamic systems/non-fusion spinal devices, Figure 1B. More recently, growth rods have been introduced for the treatment of pediatric scoliotic patients. The key biomechanical requirement of growth rods is its dynamic endurance for 5-10 years (12-25 million cycles) in the body. Therefore, given the unsuitability of the Missing Vertebra Model (F1717 – ASTM) for the evaluation of growth rods, and the high rate of ongoing mechanical failures (15-25%), a new protocol is necessary. The aim of this project to develop the protocol, undertake testing of a device and compare the outcome with missing vertebra model tests undertaken by FDA, and our group, retrieval data from FDA.

Principal Investigator: Vijay Goel, PhD

Trainee: Niloufar Shekouhi – Graduate Student

Effect of Tapered Bone Cement Injection on the PJK in a Finite Element Model with Muscle Forces

The rib cage substantially stabilizes the thoracic region of the spine and thus limits ranges of motion in all planes. In order to understand the in-depth biomechanics of the thoracic spine, a finite element model with the ribcage and muscles forces is required to simulate in vivo scenarios. The proposal is an extension of the currently funded project in which the biomechanical effects of tapered bone cement at the adjacent segments of long instrumented constructs on PJK are being pursued. The main aim of this study is to evaluate the biomechanics of the prophylactic vertebroplasty using tapered bone cement dosage in a finite element model of the spine with ribcage and muscle forces.

Principal Investigator: Vijay Goel, PhD

Trainees: Anoli Shah – PhD candidate, Manoj K Kodigudla, Amey Kelkar

Spino-pelvic Biomechanics for the Treatment of Spinal Disorders- A Finite Element Study

Providing correct sagittal balance by surgical correction of a spinal deformity is of paramount importance. Thus, the biomechanics of the instrumentation of different levels of lumbar spine and other surgical procedures for different alignment models and the possibility of proximal and distal junction kyphoses for each alignment need researched. The main aim of this study is to understand the relationships among the instrumentation of lumbar spine/ surgical procedures and sagittal imbalance using finite element analyses.

Principal Investigator: Vijay Goel, PhD

Trainee: Muzammil Mumtaz – PhD candidate

CLINICAL OUTCOMES

A validation study using gait analysis to test the accuracy of wearable sensor data in postsurgical patients

We aim to partner with the Human Performance Lab to test the accuracy and reproducibility of the signal obtained from patient worn sensors (“wearables”) during commonly performed activities 3 months following surgery when compared to a gold standard gait analysis lab data. We hypothesize that in combination with our earlier study, we will be able to identify 1) the optimal combination of data points (which data points, how many of them and over what time frame-prior study and 2) the most accurate and reproducible way to collect those data points (proposed study) that will provide an accurate picture of an individual’s clinical outcome that is predictive of standardized PRO results.

​Principal Investigator: Stefano Bini, MD

Trainees: A Pitcher, MD; I Bendich, MD; K Hwang, MD; E Kamara, MD; J Patterson, MD

Identifying Risk Factors for Pseudarthrosis

Identify risk factors for pseudoarthrosis using computational analysis of radiographs. Computer learning will be applied in order to determine if computational models can be created in order to predict pain scores and clinical outcomes, and later, reoperation in patients undergoing spinal fusion surgery.

Principal Investigator: Sigurd Berven, MD

Trainee: Kevin Taliaferro, MD

 

INNOVATIVE DEVICES/TOOLS//EQUIPMENT OR SURGICAL TECHNIQUE EVALUATION

Dynamic Joint Motions in Occupational Environments as Indicators of Injury Risk

A common request from industry is simple-to-use and cost-effective technologies that can be in real work environments to objectively monitor injury risk.  However, very few validated tools exist.  We propose developing a more comprehensive and cost-effective objective risk-monitoring platform that measures and interprets dynamic kinematics to identify injury risk for the cervical spine, lumbar spine, and shoulders.  We focus on injuries to these joints because they represent the most disabling and costly musculoskeletal conditions our industry partners face.

Principal Investigator: William Marras, PhD

Trainee: Jon Dufour

Pedicle Screw Handling During Surgery Contribute to Bioburden and Potential Approaches to Reduce Rate of Infection in Patients– A Multi-Center Study

In recent years, there has been considerable interest in refining aseptic techniques, such as intraoperative handling of implantable devices, in order to reduce the bioburden being transmitted to the patients, a majority of whom are also immunocompromised. The purpose of this study was 2-fold, to evaluate the bioburden and the species of bacteria present on each pedicle screw being implanted, and the efficacy of an intraoperative guard in reducing such occurrences, in a multi-center study.

​Principal Investigator: Anand Agarwal, MD

Trainee: TBD

Static and dynamic changes in spinopelvic parameters and sagittal alignment

A study to demonstrate how alterations in dynamic spinopelvic parameters in Adult Spinal Deformity correlate to patient outcomes and function before and after surgery allowing for further optimization of alignment.  This study will use validated spinal marker placement to capture variability in spinopelvic parameters between patients pre and post op and how this variability impacts patient outcomes.

​Principal Investigator: Shane Burch, MD

Trainee: Musa Zaid, MD

OTHER

Improvement of Push/Pull Force Assessments Using a Single-Axis Force Gauge

Pushing and pulling during manual materials handling presents a high risk for low back disorders.  Measuring push-pull hand forces requires use of a force gauge.  The objective of this study is to provide recommendations for practitioners regarding push/pull force assessments that improve the accuracy and precision of hand force estimates.

Principal Investigator: William Marras, PhD

Trainee: Eric Weston, Graduate Student

Developing Ergonomic Slotting Guidelines for Piece-Pick Product Selection in Distribution Centers

Systems to identify appropriate slotting locations for goods in distribution centers typically focus on order frequency and minimizing item travel distance.  The overall goal of this project is develop and validate a slotting methodology that optimizes facility efficiency while also minimizing physical demands on case pickers.

Principal Investigator: Steve Lavender, PhD

Low-intensity Pulsed Ultrasound as a Novel Therapy for Disc Repair and Reduction of Disc Degeneration

Damage and tears in the intervertebral disc (IVD) are associated with pain and disability and are related to risk of disc herniation and degeneration. Repairing these defects is difficult due to the limited intrinsic healing capacity of the IVD, and furthermore, current therapies for stimulating healing such as intradiscal growth factor and stem cell injections are invasive and have shown limited success rates. This project will investigate the efficacy of a novel, non-invasive technique: delivering Low-intensity Pulsed Ultrasound (LIPUS) extracorporeally to repair disc tissue defects and reduce the rate of disc degeneration and low back pain by stimulating matrix metabolism.

​Principal Investigators: Jeffrey Lotz, PhD; Christian Diederich, PhD

Trainee: Devante Horne - PhD Candidate

Magnetic Injectable Self-Setting Calcium Phosphate Cement (CPC) Compositions for Hyperthermia Treatment of Bone Tumors

Common treatments for sarcomas include surgery, radiation therapy, and chemotherapy. However, most of these treatments are highly invasive, non-responsive, and result in a significant collateral damage. The proposed effort will result in a minimally invasive procedure without the need of radiation therapy, and generate localized heat in situ. The magnetic compositions are achieved by doping injectable, self-setting calcium phosphate cement (CPC) compositions with iron. A monetite-based (Dicalcium phosphate anhydrous, DCPA) CPC composition will be used for this purpose. The microstructure, setting times, injectablility, biocompatibility, and bioactivity will be evaluated. Also, proof-of-concept for the self-set cement to generate localized temperature, which should be high enough to destroy tumors without causing collateral harm to local tissues will be provided.

Principal Investigator: Sarit Bhaduri, PhD

Trainee: Ethel Ruskin – Graduate student

Special Activities

The CDMI Spring Symposium was held on April 11-12th at The Ohio State University in Columbus, Ohio. The Fall Symposium will be at the University of California, San Francisco during Otober 24-25, 2019. Please refer to the calendar for more details. 

Locations

University of California, San Francisco

513 Parnassus Avenue
11th Floor, S-1157

San Francisco, California, 94143

United States

University of Toledo

2801 West Bancroft Street
5046 Nitschke Hall

Toledo, Ohio, 43606

United States

The Ohio State University

210 Baker Systems Engineering
1971 Neil Avenue

Columbus, Ohio, 43210

United States

614-292-6670

Northeastern University

313 Snell Engineering Center
360 Huntington Avenue

Boston, Massachusetts, 02115

United States