NIH Support

HIP BIOMECHANICS AND TISSUE DAMAGE MECHANISMS IN FEMOROACETABULAR IMPINGEMENT

F32 Fellowship 04/01/2015 – 03/31/2018 $164,996
PI/Fellow: Niccolo Fiorentino, PhD Sponsor: Andrew Anderson, PhD
Co-Sponsors: Jeffrey Weiss, PhD; Kenneth Foreman, PhD; Christopher Peters, MD; Stephen Aoki, MD
Patients with femoroacetabular impingement (FAI) have abnormal bone growths on their hip bones (femur and/or acetabulum). The abnormalities cause pain and may initiate tissue damage in the short-term. Hip osteoarthritis (OA) may also develop in FAI patients; however, the relationship between hip biomechanics, FAI and OA has yet to be quantified. This study will confirm if FAI patients have altered hip biomechanics.

IMPROVING PATIENT-REPORTED OUTCOME MEASURES FOR ORTHOPAEDIC RESEARCH AND PRACTICE

U01 09/15/2014 – 7/31/2017 $590,040
PI: Man Hung, PhD
Co-Investigators: Charles Saltzman, MD; Tom Greene, PhD
Musculoskeletal diseases have an enormous impact on health, affecting half of those 65 years and older. Our goal is to establish benchmarks and interpretability in patient-reported outcome measures. These can then be used to evaluate clinical treatment alternatives and help clinicians inform patients of outcomes after treatment.

POPULATION-BASED SHAPE AND BIOMECHANICAL ANALYSIS OF HIP PATHOANATOMY

R01 08/01/2013 – 07/31/2017 $1,334,658
PI: Andrew Anderson, PhD
Co-Investigators: Ross Whitaker, PhD; Christopher Peters, MD; Jeffrey Weiss, PhD
In this research, we will expand and integrate statistical shape analysis and biomechanics software to study the relationship between 3D anatomy and mechanical function. We will make the software publicly available and use it to investigate Femoroacetabular Impingement (FAI) and Dysplasia, two diseases believed to cause hip osteoarthritis. The research will improve the diagnosis and treatment of FAI and dysplasia.

MUSCULOSKELETAL AND FINITE ELEMENT MODELING OF FEMOROACETABULAR IMPINGEMENT

R21 05/01/2013 – 04/30/2016 $348,501
PI: Andrew Anderson, PhD
Co-Investigators: Christopher Peters, MD; Kenneth Foreman, PhD
Femoroacetabular impingement (FAI) is a reduction in clearance in the hip joint and may be the primary cause of osteoarthritis in young adults. This study will use motion capture and computer models to evaluate how the abnormal bone geometry of FAI alters the mechanics of the hip joint. This may help explain how FAI leads to osteoarthritis, and improve diagnosis and treatment.

Other Federal Support

NSC-FO: SENSORY-MOTOR INTEGRATION VIA RECORDING AND STIMULATING ARM NERVES

NSF 08/01/2015 – 07/31/2018 $785,615
PIs: Greg Clark, PhD; Greg Clark, PhD;Doug Hutchinson, MD; V. John Mathews, PhD
Co-Investigators: N/A

PERCUTANEOUS OSSEOINTEGRATED DOCKING SYSTEM FOR ABOVE ELBOW AMPUTEES

VA 09/01/2014 – 08/31/2016 $814,600
PI: Kent Bachus, PhD
Co-Investigators: N/A
The overall goal of this three-year project is to establish the foundation for developing intramedullary Percutaneous Osseointegrated Docking System (PODS) devices for patients with above elbow amputations (AEA). Using our established protocols used to develop endoprosthesis for previous sheep animal models and upcoming FDA Feasibility trials for AKA PODS devices, we will first engineer AEA PODS devices to successfully fit a pooled cadaver population of fresh-frozen human humeri. Second, we will optimize the osseointegration region of the AEA PODS devices to provide maximum initial contact with minimal host bone loss. Third, we will validate the initial risk of intra-operative cortical bone fracture and post-operative fixation expectations for AEA PODS.

NEGATIVE PRESSURE WOUND THERAPY TO SOFT TISSUES SURROUNDING PERCUTANEOUS DEVICES

VA 05/01/2015 – 04/30/2018 $812,700
PI: Kent Bachus, PhD
Co-Investigators: Roy Bloebaum, PhD; Sujee Jeyapalina, PhD
The overall goal of this three-year project is to maximize the functional recovery of patients with amputated limbs by establishing and maintaining a non-migratory biological seal between the periprosthetic tissues and the percutaneous osseointegrated docking system (PODS) device. Our previous work indicates that the periprosthetic tissues surrounding these PODS devices show a chronic wound healing response and migrate along the percutaneous interface, a process known as down growth. Clinically, chronic wounds are often closed using a technique known as Negative Pressure Wound Therapy (NPWT). We will first determine if NPWT can inhibit the down growth and subsequent infection of the periprosthetic tissues surrounding PODS devices. Second, we will establish whether NPWT is required to maintain the biological seal over time. Third, in the presence of a gap between the periprosthetic tissues and the PODS device, we will determine whether NPWT can re-establish the biological seal between the periprosthetic tissues and the PODS device.

DEVELOPMENT OF HIGHLY FUNCTIONAL, NEURALLY CONTROLLED, SKELETALLY ATTACHED, AND INTELLIGENT PROSTHETIC DEVICES

DOD 07/22/2015 – 07/21/2018 $4,520,887
PI: Kent Bachus, PhD; Charles Saltzman, MD
Co-Investigators: Roy Bloebaum, PhD; James Beck, MD; Robert Tashjian, MD; Heather Henninger, PhD; Erik Kubiak, MD
The overall goal of this 3-year research project will be to engineer and develop AEA PODS devices ready for translation to human clinical trials. This will include appropriate surgical procedures, instrumentation, and a series of AEA PODS devices required to fit a population of AEA patients with the diversity of personnel currently serving active duty for the United States or receiving treatment within either military or the VA healthcare systems. We will first engineer AEA PODS devices to successfully fit the AEA patient population. Second, we will verify the design and manufacturing processes for the AEA PODS devices. Third, we will establish the design history file and the FDA regulatory pathway required to bring AEA PODS devices to clinical trial.

A COMBINATION COATING FOR THE PREVENTION OF PERIOPERATIVE DEVICE INFECTIONS

VA 12/01/2014 – 11/30/2017 $814,514
PI: Roy Bloebaum, PhD
Co-Investigators: Dustin Williams, PhD; James Beck, MD; John Hibbs, MD

SAFETY STUDY OF PERCUTANEOUS OSSEOINTEGRATED IMPLANTS FOR PROSTHETIC ATTACHMENT

VA 10/1/2013 – 9/30/2016 $942,000
PI: Erik Kubiak, MD
Co-Investigators: N/A
This study will test a novel percutaneous osseointegrated prosthetic implant for transfemoral amputees as an alternative to a socket prosthetic limb attachment system. This work aims to address the complications associated with socket technology with a device that is implanted directly into the residual bone and can be used to improve the quality of life for Veterans amputees.

DEVELOPMENT AND CLINICAL TRIAL OF AN INSOLE SENSOR TO DETERMINE OPTIMAL LIMB LOADING IN THE REHABILITATION OF OPEN TIBIA FRACTURES

Army Medical 09/15/2012 – 07/14-2016 $389,656
PI: Erik Kubiak, MD
Co-Investigators: N/A
The purpose of this study is to use a novel load monitoring technology to correlate limb loading to tibial fracture outcomes. This study will be the first to collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing. To meet this purpose, two specific aims have been developed.

DETERMINING THE GENETIC BASIS OF ROTATOR CUFF DISEASE

VA 10/01/2011 – 02/28/2016 $352,194
PI: Robert Tashjian, MD
Co-Investigators: Lisa Cannon-Albright, PhD; Craig Teerlink, PhD
Rotator cuff repair is one of the most commonly performed orthopaedic procedures. Despite advances in surgical methods, re-tear rates, or rates of failed healing of the repaired tendon, still fail around 50% of the time. This research seeks to investigate the genetic contribution to tendon healing, in order to identify those at risk for repair failure. Understanding the genetic profile of tendon disease and healing may benefit future research by identifying possible adjuvants that may be used to improve tendon healing and outcomes.

Other Support

CRISPR-BASED SEQUENCE-SPECIFIC ENDOGENOUS UP-REGULATION OF BONE MORPHOGENETIC PROTEIN RECEPTOR TYPE A1 & 2 TO DRIVE

Lumbar Spine Research Society 10/01/2015 – 03/16/2015 $20,000
PI: Brandon Lawrence, MD
Co-Investigators: Darrel Brodke, MD

DEPUY SYNTHES FELLOWSHIP GRANT

Depuy Synthes 08/01/2015 – 07/31/2016 $15,000
PI: Patrick Greis, MD
Co-Investigators: N/A

GLOBAL CLINICAL EVIDENCE PLAN FOR VANGUARD XP (ORTHO.CR.GK9)

BioMet Manufacturing Corp 07/01/2015 – 06/30/2022 $22,341
PI: Jeremy Gilliland, MD
Co-Investigators: Christopher Pelt, MD; Christopher Peters, MD
This is a Global registry for patients who have undergone knee replacement with a new knee replacement design that saves both the ACL and PCL and is being performed by FORCE-TJR. We are a recruiting site for this study. FORCE-TJR is a national registry and research effort with over 25,000 patients already participating, who are undergoing total joint replacement. This specific research opportunity allows patients to contribute to research, based on patient reported outcomes that we hope will lead to improving the overall quality of life and health for people who require a knee replacement.

POLYAMINES AS UNIQUE TOPICAL WOUND THERAPIES

Henry M. Jackson Foundation 04/01/2015 – 03/31/2016 $290,309
PI: Dustin Williams, PhD
Co-Investigators: N/A

COMPARISON OF A LINKED TRIPLE-LOADED SINGLE ROW REPAIR TO THE STANDARD TRIPLE-LOADED SINGLE-ROW REPAIR IN A HUMAN CADAVER MODE

SoCal Ortho Research 02/01/2015 – 01/31/2016 $38,218
PI: Heath Henninger, PhD
Co-Investigators: N/A
Rotator cuff repair is often met with challenges due to poor tendon quality and short residual tendon lengths. This research examines the biomechanics of one novel method to improve construct strength and limit construct failure through use of a “linked” suture repair, where suture legs from different suture anchors are interwoven to improve repair strength and longevity.

UNDERSTANDING THE MECHANICS OF FOCAL CHONDRAL DEFECTS IN THE HIP: A FRAMEWORK TO ADVANCE TREATMENT OPTIONS

University of Utah Research Foundation 01/01/2015 – 12/31/2015 $35,000
PI: Travis Maak, MD
Co-Investigators: N/A
Localized damage to cartilage often leads to osteoarthritis if left untreated, possibly due to the altered mechanical environment it creates in the joint. While cartilage damage in the knee is well understood, facilitating the development of surgical treatments that can prevent or delay total joint replacement, there is limited data on cartilage damage in the hip. The aim of our research is to characterize the range of cartilage damage observed in the hip and use computer models to explore the mechanical effects of the damage.

EVALUATION OF IMPLANT SEATING AND SURFACE PROPERTIES ON INITIAL STABILITY OF PRESS-FIT ACETABULAR COMPONENTS

DJO Surgical 09/01/2014 – 08/31/2016 $50,605
PI: Kent Bachus, PhD
Co-Investigators: N/A
In recent decades, total hip arthroplasty has seen a transition from cemented acetabular components to uncemented components that rely on initial press-fit within an under-reamed acetabulum for stable initial fixation, osseointegration, and long term implant stability. To facilitate this goal, manufacturers have developed a wide variety of porous surface coatings, including: beaded, wire fiber mesh, titanium plasma sprayed, porous tantalum, and porous titanium. In this project, we will first evaluate the ability of a new surgical instrumentation to produce consistent preparation of the acetabulum for proper acetabular component seating. Second, we will evaluate the effect of a new titanium porous coating on the initial stability of a press-fit, uncemented, acetabular component compared to a plasma sprayed titanium coated component under tangential, or torsional, loading.

RANDOMIZED CONTROLLED CLINICAL OUTCOMES OF THE VANGUARD XP BICRUCIATE KNEE SYSTEM (ORTHO.CR.GK9B.13)

BioMet Manufacturing Corp 07/21/2014 – 08/05/2028 $529,098
PI: Jeremy Gilliland, MD
Co-Investigators: Christopher Pelt, MD; Christopher Peters, MD
This study is designed to compare the clinical outcomes in patients who receive the Vanguard XP Knee System and patients who receive the Vanguard CR Femur with CR Bearing.

The Objectives of this study include:

  1. Compare patient perception of their knee implant feeling “normal / asymptomatic.”
  2. 2. Compare clinical outcomes through 2 year standard of care follow-up.
  3. 3. Evaluate patient perceived clinical outcomes and survivorship through 10-years of follow-up.

IN-VIVO KINEMATICS OF THE ANKLE JOINT COMPLEX: A COMPARATIVE ANALYSIS USING HIGH-SPEED DUAL FLUOROSCOPY

American Ortho Foot & Ankle Society 07/01/2014 – 09/30/2015 $20,000
PI: Charles Saltzman, MD
Co-Investigator: Andrew Anderson, PhD
The objective of this research is to validate high-speed dual fluoroscopy to measure in-vivo kinematics of the subtalar and tibiotalar joints. Ground reaction forces will be measured simultaneously using an instrumented treadmill. Once validated, the protocol will analyze in-vivo kinematics of the ankle joints during treadmill walking/running as well as more complex activities such as an un-assisted toe-rise. The goal of the work is to better understand how chronic ankle instability influences joint stability as a precursor to prognosticating on the ability of surgery to restore normative kinematics to the subtalar and tibiotalar joints.

EVOLUSION STUDY USING THE ZYGA SIMMETRY SACROILIAC JOINT FUSION SYSTEM

Zyga Technology Inc 04/16/2014 – 06/15/2017 $59,045
PI: Erik Kubiak, MD
Co-Investigators: N/A
This study is designed to collect data from the use of the Zyga SImmetry Sacroiliac Joint Fusion System. Data related to confirmed fusion and SIJ pain reduction will be collected to evaluate clinical performance.

IMPROVING PAIN MANAGEMENT AND LONG TERM OUTCOMES FOLLOWING HIGH ENERGY ORTHOPEDIC TRAUMA (PAIN STUDY)

Johns Hopkins University 11/01/2013 – 03/31/2016 $21,578
PI: Thomas Higgins, MD
Co-Investigators: N/A
The objective of this study is to compare the efficacy of standard pain management vs. standard pain management combined with use of perioperative pregabalin (Lyrica) or ketorolac (Toradol) in the treatment of severe lower limb fractures.

A MULTI-CENTRE RANDOMIZED TRIAL COMPARING TOTAL HIP ARTHROPLASTY AND HEMIARTHROPLASTY ON REVISION SURGERY AND QUALITY OF LIFT

McMaster University 08/18/2013 – 01/01/2017 $3,000
PI: Erik Kubiak, MD
Co-Investigators: N/A
The primary objective is to assess the impact of total hip arthroplasty versus HEMIARTHROPLASTY (i.e. bipolar or modular unipolar) on rates of revision surgery at 2 years in individuals with displaced femoral neck fractures.

A CLINICAL EVALUATION OF THE VANGUARD XP BICRUCIATE KNEE SYSTEM EARLY INTRAOPERATIVE & CANDIDACY ASSESSMENT

BioMet Manufacturing Corp 07/26/2013 – 5/31/2016 $53,753
PI: Jeremy Gilliland, MD
Co-Investigators: Christopher Pelt, MD; Christopher Peters, MD
The Vanguard XP Bicruciate Knee System was designed for a patient with higher and more complex activity demands as it retains natural ligament structure, and may result in a more natural kinematic feeling as perceived by the patient. This study is designed to document the early Intraoperative surgical technique, candidacy for this procedure, and early clinical outcomes in a series of 100 patients.

A MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL OF EFFICACY AND SAFETY OF RILUZOLE IN ACUTE SPINAL CORD

AO North America 06/04/2013 – 03/15/2018 $47,552
PI: Darrel Brodke, MD
Co-Investigators: Brandon Lawrence, MD; Ryan Spiker, MD

EVALUATION OF VANGUARD SSK 360 REVISION KNEE SYSTEM GLOBAL DATA COLLECTION (W/PS & PSC BEARINGS ORTHO.CRG1.13)

BioMet Manufacturing Corp 04/29/2013 – 04/29/2026 $64,364
PI: Jeremy Gilliland, MD
Co-Investigators: Christopher Pelt, MD; Christopher Peters, MD
The purpose of this study is to evaluate the performance of the Vanguard® SSK 360 revision knee system. We will evaluate the ability of this system in the the restoration of mechanical alignment, clinical outcomes and survivorship.

The Investigational Plan for the Evaluation of the ACADIA(TM) Facet replacement system

Globus Medical Inc. 01/01/2013 – 01/15/2020 $213,000
PI: Darrel Brodke, MD
Co-Investigators: Brandon Lawrence, MD

A MULTICENTER PROSPECTIVE COHORT STUDY OF SACRAL FRACTURES USING PATIENT BASED AND OBJECTIVE OUTCOMES

University of Washington 01/01/2013 – 12/31/2015 $4,000
PI: Erik Kubiak, MD
Co-Investigators: N/A
The purpose of this study is to define the patient-based and radiographic outcomes of sacral fractures based on injury pattern, fracture displacement, and treated method. The prospective evaluation will gather specific data points on mechanism of injury, displacements, position at union, and disease specific and general health outcomes.

DEVELOPMENT OF NOVEL POLYAMINE ANTIMICROBIAL COMPOUNDS

Curza Global LLC 01/01/2013 – 12/31/2015 $652,940
PI: Dustin Williams, PhD
Co-Investigators: N/A

AN MRI INVESTIGATION OF SOFT TISSUES FOLLOWING TOTAL HIP ARTHROPLASTY

BioMet Manufacturing Corp 10/29/2012 – 10/28/2015 $326,396
PI: Jeremy Gilliland, MD
Co-Investigators: Christopher Pelt, MD; Christopher Peters, MD
The primary objective of the study is to estimate the prevalence of soft tissue changes in metal on metal and metal on plastic hip replacements. Also, we would like to determine if the presence of metal ion concentrations generally increases over time and if those concentrations are related to complications. Baseline levels of metal ions will be established in a relevant population, 100 patients who need, but have not yet received, a hip replacement will have metal ion levels tested.

RILUZOLE IN PATIENTS W/CERVICAL SPONDYLOTIC MYELOPATHY UNDERGOING SURGICAL TREATMENT

NOR Consult LLC 10/01/2011 – 10/01/17 $38,725
PI: Darrel Brodke, MD
Co-Investigators: Brandon Lawrence, MD; Ryan Spiker, MD

Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage: Correlation with Subsequent Post-Closure Deep Wound Infection (Bioburden Study)

Johns Hopkins University 09/01/2011 – 09/14/2015 $46,004
PI: Thomas Higgins, MD
Co-Investigators: N/A
The primary objective of this study is to characterize the contemporary extremity wound “bioburden” at the time of definitive wound coverage or closure of severe extremity wounds employing new polymerase chain reaction PCR technology. We will also determine the relationship of subsequent infections to the initial bioburden screen as defined by both PCR technology and standard microbiology techniques.

AN ASSESSMENT O FP-15 BONE PUTTY IN ANTERIOR CERVICAL FUSION WITH INSTRUMENTATION INVESTIGATIONAL PLAN

Cerapedics LLC 07/01/2010 – 10/15/2018 $137,028
PI: Brandon Lawrence, MD
Co-Investigators: Darrel Brodke, MD

VISION, MISSION, VALUES

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