Our Research 

Expanding our knowledge and helping the community 

2020 Patient Retention Rate: 94%

2019 Patient Retention Rate: 94%

TTAX01 Tissue for Diabetic Foot Ulcers

Study Title: A Multicenter Phase 3 Confirmatory Trial of Biotherapy using Cyropreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (ABULATE DFU II)

Sponsor: TissueTech, Inc.

Involved Physicians: Gregory Lundeen, MD, MPH, Scott Whitlow, MD, Spenser Cassinelli, MD

Description: The study compares whether treatment of high grade diabetic foot ulcers with standard care plus TTAX01 results in a higher chance of achieving complete wound closure over 25 weeks in comparison with standard care alone. It also will be assessing differences between the two treatment groups in long term durability of wound closure, limb preservation, and patient reported mobility.

Active: Not Yet Enrolling

None Currently

Active: Done Enrolling

Oxinium DH Total Hip Arthroplasty

Study Title: A Multi-Center, Randomized Controlled Study of Efficacy and Safety of the OXINIUM™ DH Total Hip Replacement System in Subjects with Non-Inflammatory Arthritis

Sponsor: Smith & Nephew, Inc.

Involved Physicians: Jackson Jones, MD, Sanjai Shukla, MD

Description: This is a 10 year-long study designed to assess the safety and efficacy of the OXINIUM™ DH Hip System. The OXINIUM™ DH hip replacement is not currently approved for general use by the Food and Drug Administration (FDA), hence this study is considered investigational. The investigational OXINIUM™ DH Hip System is composed of a ceramicized metal that is believed to be able to resist wear and breaking of the hip replacement. As a randomized controlled study, participants were randomized to receive either the OXINIUM™ DH device, or an already FDA-approved hip device. Outcomes for both devices will be compared in order to demonstrate the safety and effectiveness of the OXINIUM™ DH hip replacement for FDA approval.

R3 Total Hip Arthroplasty

JIIXR Total Knee Arthroplasty

Study Title: Post-Approval Study of the R3™ Biolox® Delta Ceramic Acetabular System—United States

Sponsor: Smith & Nephew, Inc.

Involved Physicians: Jackson Jones, MD, Sanjai Shukla, MD, Chad Watts, MD

Description: This is a 3-year-long study is being conducted to collect information about how the R3™ Biolox® Delta Ceramic Acetabular System performs in patients in the United States. This device has been used to treat non-inflammatory degenerative joint disease in patients in Europe. Total hip replacements are performed in patients suffering from severe hip pain due to conditions like arthritis.

Study Title: A Prospective, Multicenter, Post-Market Clinical Follow-up Study to Evaluate the Safety and Effectiveness of the Journey™ II XR Total Knee System

Sponsor: Smith & Nephew, Inc.

Involved Physicians: Jackson Jones, MD, Michael Ries, MD

Description: This is a 10 year-long study which its purpose is to collect safety and performance data from long-term use of the JOURNEY™ II XR Total Knee System. The goal of the study is to compare patient outcomes of those who received the JOURNEY™ II XR and those who received a different total knee system. The device is designed to retain both the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) leaving the knee with more functional integrity.

LEGION Total Knee Arthroplasty

Study Title: Safety and Performance of Primary Total Knee Arthroplasty using Legion™ CR Oxinium and CoCr Femoral Implants combined with Legion™/Genesis™ II XLPE High Flex Tibial Inserts

Sponsor: Smith & Nephew, Inc.

Involved Physicians: Eric Boyden, MD

Description: This is a 10 year-long study designed to assess the safety and effectiveness of the Legion™ CR Oxinium and CoCr Femoral Implants combined with LEGION™/Genesis™ II XLPE High Flex Tibial Inserts in knee replacements. The study will evaluate the performance and safety of devices previously implanted in the past. The knee replacement is intended to reduce or eliminate pain in the knee joint in patients suffering from severe knee pain due to conditions like arthritis.

Retrospective JIICR Total Knee Arthroplasty

Study Title: Safety and Performance of Journey™ II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study

Sponsor: Smith & Nephew, Inc.

Involved Physicians: Sanjai Shukla, MD, Jackson Jones, MD

Description: The purpose of the study is to evaluate the safety and performance of the Journey II CR TKS. The device retains the posterior cruciate ligament (PCL) and is designed to combine the satisfaction of a partial knee replacement with the long-term survivorship of a total knee arthroplasty and to reproduce normal motion of the knee.

Zilretta/Celestone Knee OA  

Study Title: Effect of ZILRETTA versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance. 

Sponsor: None

Involved Physicians: Timothy Bray, MD 

Description: This is a 12-week study designed to assess the effect of ZILRETTA versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance on patient with knee AO.  

Completed

STAR Total Ankle Arthroplasty

Retrospective JIIXR Total Knee Arthroplasty

Study Title: 2-Year Post-Approval Study to Investigate the STAR™ Ankle under Actual Conditions of Use.

Sponsor: Stryker Trauma & Extremities

Involved Physicians: Gregory Lundeen, MD, MPH

Description: Over the period of two years, the study tests the effectiveness of the Scandinavian Total Ankle Replacement (STAR) implant in patients suffering from severe ankle pain due to conditions like arthritis. The ankle replacement is designed to reduce or eliminate pain and instability, while still retaining some level of mobility, in the ankle joint.

Study Title: Safety and Performance of the Journey II XR Total Knee System. A Retrospective, Multicenter Study

Sponsor: Smith & Nephew, Inc.

Involved Physicians: Jackson Jones, MD

Description: The purpose of the study was to describe the safety and performance of the Journey II XR Total Knee System (TKS). The device used in this study retains the anterior cruciate ligament (ACL) and the posterior cruciate ligament (PCL), which will maintain functional integrity of the knee, to increase patient satisfaction with a partial knee replacement and have long-term survivorship of a total knee arthroplasty. The study measured the clinical, functional, and quality of life outcomes for subjects.

Wellframe Mobile App Validation

Study Title: Patient Reported Outcome Measurement Information System (PROMIS) Computer Adaptive Test (CAT) domains—Validation and Comparison with the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) in Total Knee Arthroplasty

Sponsor: Smith & Nephew, Inc.

Involved Physicians: Michael Ries, MD

Description: The purpose of the study was to collect data on patients’ mental, physical, and social health both before and after having a total knee replacement. Participants downloaded an app called Wellframe, which would prompt users to complete a number of surveys regarding their current condition. Information collected from the app was examined to monitor patient outcomes and to ensure proper functionality and determine possible areas of improvement.

Wellframe Mobile App Feasibility

Hexapod Cadaveric Study

Study Title: Comparison of reference points and deformity determined from radiographs, CT scan, and radiographic interpretive software for accuracy of tibial deformity correction: a cadaveric study. 

Sponsor: Stryker

Involved Physicians: Gregory Lundeen, MD

Description: This cadaveric study is designed to

  1. Determine the accuracy of radiographic measurements of deformity and multiplanar external fixation reference points  

  2. Determine the accuracy of radiographic measurement software of deformity and multiplanar fixation reference points 

  3. Determine the accuracy of CT measurements of deformity and multiplanar external fixation reference points. 

  4. Determine the accuracy of correction of tibia deformity using a hexapod multiplanar external fixation based on measurements directly taken from radiographs, radiographic software measurements, and CT scan. 

Stryker Hoffmann Limb Reconstruction Frame Study 

Study Title: Augmentation of internal fixation with multiplanar external fixator in high risk hind foot fusion patients

Sponsor: Stryker

Involved Physicians: Gregory Lundeen, MD

Description: 1: Determine clinical outcomes for patients who underwent a procedure including LRF for a variety of different clinical indications including Charcot, osteomyelitis, active infection, arthrodesis, post-traumatic arthritis, and failed prior surgery.  Procedures include deformity correction, arthrodesis, bone transport, distraction arthroplasty,  

2: Determine device-related outcomes, complications, and subjective benefits of the LRF

Active: Enrolling

OR3O Total Hip Arthroplasty

Study Title: Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the OR3O™ Dual Mobility System in Primary and Revision Total Hip Arthroplasty (THA) Procedures

Sponsor: Smith & Nephew, Inc.

Involved Physicians: Sanjai Shukla, MD, Jackson Jones, MD, Chad Watts, MD

Description: This is a 10 year-long study designed to assess the safety and effectiveness of the OR3O™ Dual Mobility System in primary (the first time a hip is being replaced) or revision (replacing parts of a hip which were replaced previously) hip replacements. The implant is unique from traditional hip replacements in that its design provides two points of movement, making it a dual mobility system. The hip replacement is performed to reduce or eliminate pain and instability in the hip joint resulting from conditions like arthritis.

Study Title: Feasibility Study in the Collection of Electronic Patient Reported Outcome Measurements (PROMIS) in Total Knee Arthroplasty Subjects using Wellframe App

Sponsor: Smith & Nephew, Inc.

Involved Physicians: Michael Ries, MD

Description: The purpose of the study was to collect data on the feasibility of using an app called Wellframe to measure patient outcomes before and after having a total knee arthroplasty. The study examined if individuals could use the app effectively and if they answered all surveys prompted by the app.

10.