Research

Research - A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions.

Clinical trials are designed to develop new devices, evaluate new medications, improve materials and systems, and improve surgical procedures.

Investigator - Initiated studies are managed by the same regulations that apply to the sponsor initiated studies. As an investigator, regardless of the study type, whether it is a chart review or a formal clinical trial, you will be responsible for the proper and safe conduct of your study from initiation until the completion of the study project.

All clinical trial and investigator-initiated studies are reviewed and approved an Institutional Review Board (IRB) prior to implementation. Stringent protocols are required to ensure the safety of all participating individuals and to make certain that participating surgeons follow the same study procedures and guidelines. 

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

www.clinicaltrials.gov

The Major Extremity Trauma Research Consortium (METRC) was established in September of 2009 with funding from the Department of Defense (DOD). It consists of a network of clinical centers and one data-coordinating center that works together with the DOD to conduct multi-center clinical research studies relevant to the treatment and outcomes of orthopaedic trauma sustained in the military. The overall goal of the Consortium is to produce the evidence needed to establish treatment guidelines for the optimal care of the wounded warrior and ultimately improve the clinical, functional and quality of life outcomes of both service members and civilians who sustain high energy trauma to the extremities.

www.metrc.org

Learning Lab

The ORF is the business and education manager for the Learning Lab at OrthoIndy Hospital. The learning lab is to facilitate education of surgeons and staff for new/updated devices, surgical training and surgical techniques. Please contact Jenna Sallee at (317) 802-2880 for more information. 

Trauma Active Studies

Musculoskeletal Injuries Associated with Moped and Motorized Scooter Accidents 

Comparative Outcomes of Total Elbow Arthroplasty and Hemiarthroplasty 

Quality of Fracture Reduction and its Influence on Functional Results in Patients with Pilon Fractures  

Title: A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixator or Internal Fixation with Intramedullary Nails (FIXIT) 
Sponsor: METRC / DoD
Investigator: Drs. Crichlow and Reveal
Objective: To compare the outcomes associated with modern ring external fixators versus standard internal fixation techniques in treating “severe” open tibia shaft or metaphyseal fractures with or without a bone defect of any size.

Title: Assessment of Severe Extremity Wound Bioburden at the time of Definitive Wound Closure or Coverage (BIOBURDEN)
Sponsor:  METRC / DoD
Investigator: Drs. Crichlow and Reveal
Objective: Characterize the contemporary extremity wound “bioburden” at the time of definitive wound closure of severe extremity in order to determine the correlation of the identified wound pathogens at the time of wound closure with subsequent deep wound infections, the correlation of PCR results with those obtained from standard hospital microbiology; and the efficacy, if any, of antibiotics used in the care of the wound.

Title: Outcomes Following Severe Distal Tibia, Ankle, and/or Foot Trauma:  Comparison of Limb Salvage vs. Amputation (OUTLET)
Sponsor: METRC / DoD
Investigator: Drs. Crichlow and Reveal
Objective: To compare 18 month functional outcomes and health related quality of life (HRQoL) of patients undergoing salvage versus amputation following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss.

Spine Active Studies

Title: A complete evaluation including outcomes and cost-analysis of a Transforaminal Lumbar Interbody Fusion (TLIF) population at a specialty hospital.
Sponsor: Investigator Initiated
Investigators: Drs. Dietz, Coscia, Huler, Schwartz, Trammell, Jackson; Flint, Fitzpatrick
Objective: The primary purpose of this study is to analyze the use of bone grafts (specifically INFUSE) and potential complications that may have occurred in TLIFs.

Title: Osteocel® Plus in Anterior Lumbar Fusion (ALIF): Evaluation of Radiographic and Patient Outcomes
Sponsor: Nuvasive
Investigators: Drs. Schwartz, Dietz, Trammell
Objective: This study is being done to obtain information about the use of Osteocel Plus as a graft substitute versus the other options that are currently available.

Title: A Prospective, Randomized, Controlled Pivotal Clinical Investigation of DIAM™ Spinal Stabilization System in Patients with Lumbar Degenerative Disc Disease
Sponsor: Medtronic
Investigators: Drs. Schwartz, Dietz
Objective: The purpose of this study is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System for the treatment of single-level degenerative disc disease in your lumbar spine.

Title: A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following Product:  The Polaris Deformity System
Sponsor: Biomet
Investigator: Dr. Trammell
Objective: This study is being done to test the safety and effectiveness of the Polaris Deformity Spinal System for the treatment of spinal deformities in people who are skeletally mature.

Title: A Retrospective Evaluation of the Use of Infuse in the Lumbar and Thoracic Spine
Investigators: Drs. Trammell, Schwartz, Dietz, Huler, Coscia, Jackson. Flint, Fitzpatrick
Sponsor: Investigator Initiated
Objective: The study examines both fusion and complication rates associated with its use in the posterior and anterior thoracic and lumbar spine.

Title: A Retrospective Evaluation of the Use of Infuse in the Cervical Spine
Investigator: Drs. Trammell, Schwartz, Dietz, Huler, Coscia, Jackson
Sponsor: Investigator Initiated
Objective: The study examines both fusion and complication rates associated with its use in the posterior and anterior cervical spine.

Title: Retrospective comparison of infection rates in instrumented and non-instrumented spine surgery
Investigator: Drs. Schwartz, Huler, Jackson, Dietz, Coscia, Dodd, Trammell
Sponsor: Investigator Initiated
Objective: To compare infection rates in instrumented and non-instrumented spine surgery.

Title: Instrumented Lumbar Corpectomy with rhBMP-2 and Mastergraft Putty in 3 Different Devices- A Study in Sheep
Investigator: Dr. Schwartz
Sponsor: Medtronic
Objective: To evaluate two different formulations of rhBMP-2 in tow structural devices and compare them to autograft in an instrumented sheep corpectomy model.

Title: A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc-LP at a Single Level for Symptomatic Cervical Disc Disease.
Investigators: Drs. Schwartz, Dietz, Huler, Coscia
Sponsor: Medtronic
Objective: This study is being conducted to evaluate the safety and effectiveness of the ACD-LP for the single-level surgical treatment of cervical (neck) disc disease.

Title: Comparison of tensional strength of attachment of four multi-axial screw saddles to the bone screw head (pedicle screw)
Investigator: Dr. Trammell
Sponsor: Investigator Initiated
Objective: To design and test a jig used for pedicle screw torsional, 2-axis rotational plane evaluation.

Registry Studies

Spine Surgery Database (Spine Database #1)

Spine Surgeons Oswestry and Neck Pain Disability Index Outcomes Study (Spine Database #2)

Jack Farr, MD Active Studies

Determining the Minimal Clinical Important Difference (MCID) and Patient Acceptable Symptomatic State (PASS) for Patients Undergoing Articular Procedures of the Knee

Multi-Center Experience with ACI in the Patellofemoral Compartment

Decreased Re-intervention Rate with Collagen Membrane ACI

A Prospective Double Blinded, MultiCenter, Randomized, Controlled Trial to Evaluate Mechanical Debridement vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions

NeoCart: A Randomized Comparison of Neocart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee

An Investigation of ReNu™ Knee Injection: Monitoring the Response of Knee Function and Pain in Patients with OsteoArthritis

Longitudinal Histologic Assessment and Gen Expression Profiling of Healing Cartilage Defects

Prospective, MultiCenter Single Arm Pilot Study To Evaluate Symptom Relief in Patients with Medial Knee OsteoArthritis (OA) Treated with the KineSpringÒ Knee Implant for Load Reduction (SOAR)

Knee Creations SCPÒ Observational Cohort Follow-up Study

Prospective Efficacy Evaluation of Subchondroplasty™ for the Treatment of Defects Associated with Tibial Marrow Lesions

Validity of an Interactive Technique for Collecting Patient Reported Outcomes of Orthopaedic Procedures

A Post-Market, Longitudinal Data Collection Study of Articular Cartilage Defects of the Knee Treated with Denovo® NT Natural Tissue Graft Protocol#CSU2010-22B

A Post Market Study to Evaluate the Chondrofix Osteochondral Allograft Utilized for Treatment of Subjects with Cartilage Lesions in the Knee

AANA: Acute Complications of Knee and Shoulder Arthroscopy

A Feasibility Study to Determine the Up-Regulation of Anti-inflammatory Cytokines in Whole Blood From Patients with Osteoarthritis

A Multicenter, Randomized, Pivotal Study to Evaluate the Safety and Efficacy of the Cartilage Autograft Implantation System (CAIS) for the Surgical Treatment of Articular Cartilage Lesion of the Knee

A Long-Term Follow-up Study of Chondrogen™ Adult Universal Cell Delivered by Intra-articular Injection Following Meniscectomy in Patients 18-60 Years

Regeneration Technologies, Inc. Registry of Biocleanse® Meniscus Transplants

A Post Market Study of Articular Cartilage Defects of the Knee Treated with DeNovo® NT, Natural Tissue Graft.

An Open-Label Phase I/II Pilot Study to Evaluate Articular Cartilage Defects of the Knee with a Neocartilage Implant

Collection of Specimens from Joint Replacement Surgery for In-Vitro Osteoarthritis Research

Evaluation Outcomes After Standard of care Operative and Non-operative Management of the Knee 20 Year Follow-up

Surgical Outcome Studies:

  • Anterior Cruciate Ligament Reconstruction

  • Anteromedialization (AMZ)

  • Carticel Implantation/ Articular Cartilage Implantations

  • Fresh Osteochondral Shell Transplantation

  • High Tibial Osteotomy

  • Medial Patellofemoral Ligament Reconstructions

  • Meniscal Transplantation

  • Patellofemoral Arthroplasty

  • Total Knee Arthroplasty

Frank Kolisek, MD Active Studies

Biolox Delta: 5-year prospective study of ceramic femoral heads on poly liners

Multi-Knee Study: Comparison of PS, CR, MBK, and NRG knee designs at 10 years

Accolade I: Long-term follow-up this hip system

Accolade II: Early results of this hip system

Avon PFA: Long-term f/u of a unicompartmental (patellofemoral) knee system

BCR Knees (bicruciate retaining): May be sponsored or surgeon-initiated - knees not available for another year or two

DJO E-stim: Prospective study of new knee brace with active TENS unit

Lilly OAAB: Tissue sample collection in rheumatoid patients undergoing TKA

LIS TKA: Minimally invasive knee surgery

N2Vac vs. Xfire vs. X3: a comparison of three bearing surfaces

Out vs. In TKA: 23 hour stays versus overnight

PS MBK IDE: Scorpio Mobile Bearing Knee system

Rejuvenate Monolithic Hip Stem: A new monolithic stem

Scorpio CR Knees: Long-term follow-up of a cruciate-retaining knee design

Scorpio PS Knees: Long-term follow-up of a posteriorly-stabilized knee design

Secur-Fit Stem: 10-year Comparison between Omnifit HA and Secur-fit stems

ShapeMatch Cutting Blocks: New "anatomical" cutting blocks for total knee arthroplasty

David A. Fisher, MD Active Studies

Mid to Long Term Follow-up on Selected DePuy Implants

A Prospective, Comparative, Randomized, Double Blind, Multi-Center Study of the Uniglide Mobile Bearing Unicondylar Knee System vs. Uniglide Fixed Bearing Unicondylar Knee System

The Impact of Pelvic Parameters and Sagittal Balance on Acetabular Cup Alignment in Total Hip Arthroplasty

Registry Studies

Research and Recruitment Database for Hip, Knee, and Shoulder Replacement Surgery Subjects

Research and Recruitment Database for Total Joint Replacement Surgery Subjects

Outcomes of Knee Arthroplasty using a DePuy Primary Knee System (11011)

Stephen L. Kollias, MD Active Studies

“Functional Outcomes of Anterior Cruciate Ligament Reconstruction Using Low Dose – Low Temperature Irradiated Tibialis Anterior Allograft”

“Outcomes of all Arthroscopic Massive Rotator Cuff Repair Using a Novel Technique”

Sanford S. Kunkel, MD Active Studies

Title: “OsteoSponge® SC Registry - Efficacy of this novel Bone Void Filler for filling defects in the subchondral region of the Knee”
Sponsor: Bacterin International, Inc.
Objective: The purpose of this study is gather information regarding the outcomes for the use of a bone void filler called OsteoSponge® SC for patients who have subchondral defects in the knee.