FDA Clinical Trials

FDA Clinical Trials
Each year hundreds of patients are referred to medical clinics, such as OrthoCarolina, P.A., for state-of-the-art care and for participation in clinical trials. Clinical trials are designed to develop new devices, evaluate new medications, improve materials and systems, and improve surgical procedures. At the present time, the OrthoCarolina Research Institute is working with fourteen FDA-controlled clinical trials and two Humanitarian Device Exemption (HDE) studies that serve and support the public in providing state-of-the-art surgical treatments and techniques. Representative of these investigative trials are a total shoulder prosthesis design and instrumentation evaluation, a shoulder stability device study, an ankle fusion and ankle arthroplasty comparison, an assessment of design and materials for total joint replacements, and an evaluation of treatment options for diabetic foot infections.

All clinical trial proposals and studies are reviewed and approved by the OCRI Research Advisory Committee (RAC) and 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. 



Studies Open to Enrollment:

Total Joint Replacement

Title: A prospective, comparative, randomized, single blind, multi-center study of the TrinityTM BIOLOX deltaTM Ceramic-on-Ceramic Total Hip Replacement System vs. TrinityTM Acetabular Hip System
Sponsor: Corin
Investigators:
Drs. Masonis, Melvin, and Andrew Patterson PA-C
Objective: To demonstrate clinical non-inferiority of an investigational device, TrinityTM BIOLOX deltaTM Ceramic-on-Ceramic Total Hip System, with respect to a Composite Clinical Success criterion (CCS) at the Month 24 endpoint

Title: Exploratory evaluation of the potential for long-term retention of Gadolinium in the bones of patients who have received Gadolinium based Contrast Agents according to their medical history
Sponsor: Ecron Acunova GmbH
Investigators: Dr. J. Bohannon Mason
Objective: To further investigate the safety of six different commercially used Gadolinium-containing contrast agents.

Title: Cross-Sectional, Multi-Center Evaluation of 8 Year Metal Ion Trends For Pinnacle MoM System Used in Primary Total Hip Arthroplasty
Sponsor: DePuy Orthopaedics
Investigators: Dr. J. Bohannon Mason
Objective: To evaluate chromium and cobalt (types of metal used to make the hip implants) blood levels (serum and whole blood) trends over time by evaluating different groups of patients that have had a metal-on-metal hip surgery between 1 and 8 years ago compared to patients that haven’t had surgery yet.

Title: Post Market Clinical Follow-up Study of the Zimmer® Vivacit-E® Highly Crosslinked Polyethylene Liner used with the Continuum® Acetabular Shell (CMU2011-09H)
Sponsor: Zimmer
Investigators: Dr. Thomas McCoy
Objective: To collect information to evaluate how well the patients are doing after their treatment with the Zimmer Vivacit-E polyethylene liner. The results of this study may provide information that will add to the knowledge base of hip replacement surgery.

Title: A Randomized Clinical Study to Compare the Safety and Efficacy of the Oxford® Cementless Partial Knee System
Sponsor: Biomet Manufacturing Corp.
Investigators: Dr. Mark Suprock
Objective: To determine if the safety and effectiveness of the Cementless knee is comparable to the cemented knee.


Pediatrics

Title: “VEPTR Implantation to Treat Children with Early Onset Scoliosis without Rib Abnormalities: A Prospective Multicenter Study”
Sponsor: Chest Wall and Spine Deformity Study Group
Investigator: J. Michael Wattenbarger, MD
Objective: To evaluate the use of unilateral or bilateral VEPTR devices, with or without expansion thoracoplasty, for preventing further progression of the Cobb angle, allowing for spinal growth and improving pulmonary function in the treatment of children with progressive scoliosis without rib abnormalities.

Sports Medicine

Title: Post-Market, Longitudinal Data Collection Study of DeNovo® NT for Articular Cartilage Defects of the Knee CSU2010-22B
Sponsor: Zimmer
Investigators: Drs. James Fleischli, Dana Piasecki, and Aaron Hewitt, PA-C
Objective: The purpose of this post-market study, is to collect additional long-term outcomes for DeNovo® NT treatment of articular cartilage lesion(s) of the knee in a standard clinical setting. Outcomes to be assessed include pain, function, activity levels and healthcare resource use. This is a post-market, multicenter, cohort study of the commercially-available DeNovo® NT graft.

Title: Prospective, Multi-Center, Pilot Study to Evaluate Symptom Relief in Patients with Medial Knee Osteoarthritis (OA) Treated with the KineSpring® Knee Implant for Load Reduction
Sponsor: Moximed, Inc.
Investigators: Dr. James Fleischli
Objective: To test whether an investigational device called the KineSpring Knee Implant is safe and provides relief of knee pain and improves knee function when used to treat patients with knee OA. This study will provide information that may help make this device more widely available to other people with OA.
www.soartrial.com

Spine
Title: Prospective, Concurrently Controlled, Multi-Center Study to Evaluate the Safety
and Effectiveness of the Spinal Kinetics™ M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Symptomatic Cervical Radiculopathy
Sponsor: Spinal Kinetics, Inc.
Investigators: Drs. Alden Milam, Al Rhyne, Bruce Darden, Leo Spector, Brad Segebarth, and Eric Laxer
Objective: To evaluate the safety and effectiveness of the M6-C artificial cervical disc compared to Anterior Cervical Discectomy and Fusion (ACDF).


Studies Closed to Enrollment (Long-term follow-up):

Total Joint Replacement

Title:
A prospective, multicenter, non-randomized, clinical outcomes study of the R3® Acetabular System in patients with degenerative hip disease
Sponsor: Smith & Nephew
Investigator: John L. Masonis, MD
Objective: To determine the long-term safety and effectiveness of the R3 Acetabular System.

Title: Multi-Center Trial of the Continuum™ Ceramic Bearing System in Total Hip Arthroplasty
Sponsor: Zimmer
Investigators: Drs. Thomas McCoy and Erin Hermann, PA-C
Objective: To evaluate the safety and efficacy of the Continuum™ Ceramic Bearing System in unilateral primary total hip arthroplasty.

Title: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing System
Sponsor: Smith & Nephew
Investigator: John Masonis, MD
Objective: To evaluate the longer-term safety and effectiveness of the BHR system. 

Title:
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee (Protocol#: 07-100)
Sponsor: Zimmer, Inc.
Investigators: Drs. Water Beaver and Thomas McCoy
Objective: The objective of Post Approval Study (PAS) is to assess the long-term performance of the NexGen® LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.

Title: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing System
Sponsor: Smith & Nephew
Investigator: John Masonis, MD
Objective: To evaluate the longer-term safety and effectiveness of the BHR system.

Title:
RegenerexTM Tibial Tray Multi-Center Data Collection
Sponsor: Biomet
Investigators: Dr. Suprock, Vanguard, and April Wrikstrom PA-C
Objective: To document the performance and clinical outcomes of the RegenerexTM Tibial Tray

Hand

Title:
A Phase II randomized, single ascending dose, double-blinded, placebo controlled, multi-center study of the effects of rhPDGF-BB Injection on lateral Epicondylitis
Sponsor: BioMimetic
Investigators: Drs. Perlik, Gantt, Osier, Baker, Ward, Chadderdon, Gaston, Lewis, Gaul, Boatright, and Hamid
Objective: To evaluate the effectiveness of rhPDGF-BB Injection, as a treatment for lateral epicondylitis

Title:
A Phase 2a, double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the safety and effectiveness of AA4500 In the treatment of Dupuytren’s disease nodules
Sponsor:
Auxilium Pharmaceuticals, Inc.
Investigators:
Drs. Perlik, Gantt, Osier, Baker, Ward, Chadderdon, Gaston, Lewis, and Gaul
Objective: To assess the safety and effectiveness of AA4500 in treating palmar Dupuytren’s disease nodules.


Spine

Title: SMART- Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain
“A prospective randomized, double-blind, controlled investigation evaluating the Intracept Intraosseous Nerve Ablation System for the reduction of pain in patients with chronic axial low back pain “
Sponsor: Relievant Medisystems
Investigators: Drs. Al Rhyne, Sam Bhagia, and Monica Overbaugh, PA-C
Objective: To evaluate the safety and effectiveness of RF ablation using the Intracept Intraosseous Nerve Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain. 

Title: A Multicenter, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of PRODISC-C® to Anterior Cervical Discectomy and Fusion (ACDF) Surgery in the Treatment of Symptomatic Cervical Disc Disease (SCDD). [FDA-Device clinical trial] Sponsor: Synthes Spine
Investigators: Drs. Daniel Murrey, Al Rhyne, Bruce Darden, and Eric Laxer
Objective: To compare the safety and effectiveness of PRODISC-C® (investigational artificial disc implant) to ACDF surgery in the treatment of SCDD. The intent of PRODISC-C® is to treat degenerative disc disease by reducing the pain and neurological signs and symptoms, without fusing the vertebrae.

Title:
The Investigational Plan for the Evaluation of the ACADIA™ Facet Replacement System (Pivotal IDE Trial) (Protocol #: 1020-9052)
Sponsor: Globus Medical 
Investigators: Drs. Al Rhyne, Eric Laxer, Leo Spector, and Alden Milam
Objective: The purpose of this study is to evaluate the safety and effectiveness of the ACADIA Anatomic Facet Replacment System (AFRS) in patients with lateral, lateral recess and/or central canal stenosis due to facet degeneration at a single level from L3 to S1 who require a lumbar decompression and facetectomy compared to an instrumented posterolateral fusion control group. Safety of the AFRS device will be evaluated by the incidence, severity and device or procedure relatedness of all adverse events over the 24 month assessment period as compared to the control group. Effectiveness of the AFRS will be based on the improvement in symptom-related questionnaire scores, function, and neurological status.

Foot & Ankle

Title: A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment™ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
Sponsor: Biomimetic Therapeutics
Investigators: Drs. Robert Anderson, Bruce Cohen, W. Hodges Davis, Carroll Jones, and Greg Sanders, PA-C
Objective: To demonstrate equivalent clinical and radiologic outcomes as “gold
standard” (Autologous Bone Graft) in a representative clinical model
(hindfoot fusions) 

HUMANITARIAN DEVICE EXEMPTION (HDE) STUDIES (1)

A Humanitarian Use Device is a device used to diagnose or treat a disease or condition that affects fewer than 4,000 individuals in the United States per year and for which no similar device is available. The U.S. Food and Drug Administration (FDA) approves the use of Humanitarian Devices based primarily on evidence that it does not pose a significant risk of injury to the patient and that the potential benefit of the device to the health of the patient outweighs the risk of its use.

Title: HDE Application for Vertical Expandable Prosthetic Titaniium
Rib (VEPTR)
Investigator: J. Michael Wattenbarger, MD
Objective: The Vertical Expandable Prosthetic Titanium Rib (VEPTR) is authorized by Federal law for use in the treatment of Thoracic Insufficiency Syndrome (TIS), the inability of the thorax to support normal respiration or lung growth, in skeletally immature patients. The effectiveness of this device for this use has not been demonstrated.