Research & Studies at CFO

Research Department Overview

The Center for Orthopaedics Research Department is dedicated to conducting high quality clinical research studies in multiple therapeutic areas of medicine. The department specializes in phase II, III, and IV clinical trials for the pharmaceutical and biotechnology industries. The goal of the department is to aid in the development of devices and drugs, by helping to generate new findings that will improve the quality of life for patients, and bring new effective treatments to the market.

The department has dedicated research coordinators that are integral to each study. The coordination of the department is overseen by a director that has 20 years’ experience in conducting industry sponsored trials. The Principal Investigators responsible for the studies provide the coordinators with oversight and support, to ensure the promotion of patient safety and production of quality data for each trial.

We are a metrics driven site that is able to deliver quick study start-ups and meet stringent sponsor deadlines without compromising data integrity. Center for Orthopaedics is able to utilize the services of central institutional review boards (IRBs) for protocol approval and oversight; allowing for a more expedited process. The department has an outstanding patient retention rate among the studies conducted at the site, which has been boasted by industry sponsors.

The orthopaedic research takes place in a state of the art 41,000 square foot facility located on 75 acres of land that is continually being developed. The facility is also home to Center for Orthopaedics' Imaging Center and RehabOne, an orthopedic and sports medicine physical therapy group. We are located off Interstate 210, which loops from Interstate I-10, providing easy accessibility to patients in the vast surrounding areas. For sponsors and clinical research organizations (CROs), the Lake Charles Regional Airport is 5 miles from the facility.

Our orthopaedic physicians participate in multiple community events throughout the year spreading awareness on various musculoskeletal topics. Some of these events include health fairs, sponsorships, educational seminars and other charitable events as a means of giving back to the community. Word of mouth has been our best advertisement regarding the exceptional experience patients have had with our organization. We will continue to strive to meet the needs of our patients, while remaining on the cutting edge of medical breakthroughs.

For information on studies at Center for Orthopaedics, contact:

DeAnne Winey-Ward, Director of Research

1747 Imperial Boulevard

Lake Charles, LA 70605

Phone: (337) 312-8405

Email: dwiney@imperialhealth.com

Our Studies

Study Name: BIRMINGHAM HIP Resurfacing System (BHR) Post Approval Study: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing.

Sponsor: Smith & Nephew

Device Name: BIRMINGHAM HIP Resurfacing (BHR) System

Principal Investigator: John Noble Jr., M.D.

ClinicalTrials.gov Identifier: NCT00611585

The purpose of the BIRMINGHAM HIP Resurfacing (BHR) Clinical Study is to collect additional information on the performance of this particular type of hip implant device. This is a 10 year study.

The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint replacement. The BHR system spares more of the hip joint bone compared with the total hip replacement devices.

Center for Orthopaedics is 1 of 7 sites participating in this study across the country. We are the only site in Louisiana, as well as the only southern gulf coast state participating in the study. The first patient enrolled at Center for Orthopaedics was in October 2007. Enrollment at this site closed in March 2011.

Study Name: A Prospective, Post Market, Multi-Center Study of the Tritanium® Primary Acetabular Shell.

Sponsor: Stryker Orthopaedics

Device Name: Tritanium® Acetabular Shell

Principal Investigator: John Noble Jr., M.D.

ClinicalTrials.gov Identifier: NCT01063751

The purpose of this study is to evaluate the success rate of cementless primary hip replacement with the Tritanium® Acetabular Shell as compared to the success rate of similar competitive devices as reported in scientific journals. This is a 10 year study.

Center for Orthopaedics is 1 of 8 sites participating in this study across the country. We are the only participating site in Louisiana. The first patient enrolled at Center for Orthopaedics was in July 2011. Enrollment at this site closed in November 2015.

Study Name: A Prospective, Post-Market, Multi-Center Study of the Outcomes of the

Triathlon Tritanium Knee System.

Sponsor: Stryker Orthopaedics

Device Name: Triathlon Tritanium Tibia and Patella

Principal Investigator: John Noble Jr., M.D.

ClinicalTrials.gov Identifier: NCT02155712

The purpose of this study is to learn if the Triathlon Tritanium cementless knee replacement works as well as a cemented knee replacement. This study has two groups: Cohort Group 1 and Cohort Group 2.

Group 1 is made up of patients who get the Triathlon Tritanium cementless knee replacement. Patients in this group will be followed for 10 years.

Group 2 is made up of patients who get a Triathlon CR or PS cemented knee replacement. Patients in this group will be followed for 5 years.

Center for Orthopaedics is 1 of 10 sites participating in this study across the country. We are the only participating site in Louisiana. The first patient enrolled at Center for Orthopaedics was in May 2015. Enrollment at this site closed in December 2016.

Study Name: A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the Trident II Tritanium Acetabular Shell.

Sponsor: Stryker Orthopaedics

Device Name: Trident II Tritanium Acetabular Shell

Principal Investigator: John Noble Jr., M.D.

ClinicalTrials.gov Identifier: NCT02999009

The purpose of this study is to review the performance and success rate of an FDA (Food and Drug Administration) approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells. This is a 10 year study.

Center for Orthopaedics is 1 of 8 sites participating in this study across the country. We are the only participating site in Louisiana. The first patient enrolled at Center for Orthopaedics was in September 2018. Enrollment remains open at this site.