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:
Spine
Title: A Prospective, Multi-center, Double-blind, Randomized, Placebo Controlled Pivotal Study of Ultrasound Therapy as Adjunctive Therapy for Increasing Posterolateral Fusion Success Following Single Level Posterior Instrumented Lumbar Surgery (Protocol #: EX-SPINE0907)
Investigators: Drs. Bruce Darden, Leo Spector, Alden Milam, Al Rhyne
Objective: The purpose of this study is to determine if low-intensity ultrasound (sound waves) is a safe and effective add-on treatment for obtaining a solid (complete) spinal fusion after spinal fusion surgery. The Exogen 4000+ Bone Healing System is a medical device that uses ultrasound to help the healing of injured bones.
Title: A Multicenter, Randomized, Blinded, Saline-Controlled Trial of Resorbable Biologic Disc Augmentation for Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) with the Biostat® System (Protocol #: SR-BX01-2007)
Investigators: Dr. Ron VanDerNoord, and Monica Overbaugh, PA-C
Objective: The purpose of this investigation is to establish the safety and efficacy
of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another group receiving a preservative-free normal
saline control delivered with the Biostat Delivery Device.
For more information, please visit www.lowbackstudy.com
Pediatric Spine
Title: VEPTR Implantation to Treat Children with Early Onset Scoliosis without Rib Abnormalities: A Prospective Multicenter Study
Investigators: Drs. J. Michael Wattenbarger
Objective: The purpose of this study is to evaluate the use of unilateral or bilateral Vertical Expandable Prosthetic Titanium Rib (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.
Adolescent Ankle
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects with Ankle Sprain (Protocol: FS-67-HP01-E02)
Investigators: Drs. James Foster and Pressly Gilbert; Aaron Hewitt, PA-C; Shawn O'Keefe, PA-C; Greg Sanders, PA-C; Todd McLaughlin, PA-C; Mike Long, PA-C; Paul Coleman, PA-C; Tony Connot, PA-C; George Collins, PA-C
Objective: The purpose of this study is to assess the safety and efficacy of single and multiple applications of the FS-67 patch in adolescent subjects with ankle sprain
Study brochure
Elbow
Title: “Recover® Kit for Chronic Elbow Tendinosis”
Sponsor: Biomet Biologics
Investigators: R. Glenn Gaston, MD; Paul C. Perlik, MD; John S. Gaul, MD; David S. Baker, MD; Lois Osier, MD; Christopher Chadderdon, MD; Dan Lewis, MD; Erika Lumsden, MD; W. Alan Ward, MD; James R. Boatright, MD; H. Yates Dunaway, MD; James E. Fleischli, MD
Objective:To compare the safety and efficacy of autologous platelet concentrate injections with Bupivacaine injections in clinician assessments of elbow pain and function in patients suffering from chronic elbow epicondylar tendinosis.
Hip
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.
Knee
Title: “INVESTIGATIONAL PLAN – PIVOTAL STUDY VANGUARD™ ROTATING PLATFORM (RP) KNEE SYSTEM”
Sponsor: Biomet
Investigator: Mark D. Suprock, MD ad April Wikstrom, PA-C
Objective:To evaluate the safety and effectiveness of the Vanguard™ RP Knee System (investigational device) compared to a fixed bearing knee (control treatment) using the following endpoints at two years postoperative.
o Assessment of Knee Score
o Removals or revisions of any component of the device
o Pending removals or revisions of any component of the device
o Presence/absence of osteolysis
o Migration/subsidence of any component
Sports Medicine/Cartilage Restoration
Title: A Randomized Comparison of NeoCart® to Microfracture for the Repair of Articular Cartilage Injuries in the Knee (Clinical Protocol # 8-01)
Sponsor: Histogenics Corporation
Investigators: Drs. James Fleischli and Dana Piasecki
Objective: The objective of this trial is to 1) evaluate the safety and efficacy of the aurtologous cell matrix, NeoCart, in the repair of cartilage effect of the femur (lateral medial and trochlea) and 2) compare NeoCart safety and efficacy to microfracture treatment.
Press Release
Patient Overview
Studies Closed to Enrollment (Long-term follow-up):
Foot and Ankle
Title: A Radiographic and Clinical Study Evaluating a Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem and Osteoprogenitor Cells (Trinity® Evolution™ Viable Cryopreserved Cellular Bone Matrix)1 in Subjects Undergoing Tibiotalar Arthodesis With or Without Concomitant Hind Foot Fusion (Protocol ID Number: TY01AF)
Sponsor: Orthofix International
Investigators: Drs. Robert Anderson, Bruce Cohen, Carroll Jones, and W. Hodges Davis
Objective: The primary objective of this study is to obtain clinical and radiographic evidence of fusion using an allogeneic cancellous bone cellular matrix called Trinity Evolution Matrix instead of autograft in subjects undergoing tibiotalar arthrodesis (ankle fusion) with or without hindfoot fusion.
Hip
Title: Performance of the Implex Hedrocel Ceramic Bearing Total Hip Replacement (THR) System in Primary Total Hip Arthroplasty (THA) [FDA-controlled Phase III clinical trial]
Sponsor: Zimmer, Inc.
Investigator: John Masonis, MD
Objective:To evaluate the outcome of the Hedrocel?Ceramic Bearing THR System when used as indicated for total hip arthroplasty (THA) in patients with severe degeneration, trauma, or other pathology of the hip joint.
Title: A Randomized, MultiCenter, Trial of Cermic on Metal-Hip replacement device [FDA-Device clinical trial]
Sponsor: DePuy/Johnson & Johnson
Investigators: Drs. Thomas Fehring, Bill Griffin, Bo Mason
Objective: To gather sufficient clinical, functional, and radiographic data due to permit valid scientific comparisons between experimental and control group outcomes. This information will further advance the knowledge of the medical and scientific community.
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.
Knee
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.
Spine
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, 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: A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate degenerative Lumbar Spinal Stenosis
Sponsor: Synthes Spine
Investigators:Drs. Bruce Darden, Dan Murrey, Leo Spector, Alden Milam, Al Rhyne
Objective:The purpose of this study is to assess the effectiveness and the safety of the In-Space device compared to the X STOP Interspinous Process Distraction device (X STOP)
Title: The Investigational Plan for the Evaluation of the ACADIA™ Facet Replacement System (Pivotal IDE Trial) (Protocol #: 1020-9052)
Investigators: Drs. Al Rhyne, Leo Spector, Alden Milam, Eric Laxer
Objective: The primary objective of this study is to evaluate the safety and effectiveness of the ACADIA facet replacement system (AFRS) through 24 post-operative months compared to an instrumented posterolateral fusion control.
Humanitarian Device Exemption (HDE) Studies
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: Use of the Ascension PIP Finger Implant
Investigators: Drs. Lois Osier, Paul Perlik, John Gaul, David Baker, and James Boatright (Presbyterian Hospital), Drs. James Boatright, Alan Ward, Erika Lumsden, Forney Hutchinson (Carolinas Healthcare System)
Objective:The Ascension PIP is allowed by Federal law for use in replacing the proximal interphalangeal (PIP), or the middle finger joint, in your hand.The Ascension PIP has been approved by the Food and Drug Administration (FDA) for use as a Humanitarian Use Device (HUD).
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.
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