Studies Open to Enrollment:
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Title: A Multicenter, Double-Blind Randomized, Placebo Controlled Study of the Efficacy and Safety of pregabalin in the Treatment of Subjects with Post-Operative Pain
Following Total Arthroplasty (TKA) Protocol A0081133-Pfizer
Investigators:Drs. Bryan Springer, Thomas Fehring, Walter Beaver
Objective:The primary objective of the trial is to asss the efficacy of pregabalin compared to placebo on pain following total knee arthroplasty at approximately 48 hours post surgery,
measured using a subject reported asssment of worst pain.
Title: A Pha 2. Double-Blind, Double-Dummy, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Twice Daily Dosing and Once Daily Dosing of
YM150 in Subjects Undergoing Primary Elective Knee Arthroplasty (Protocol #: 150-
CL-033)
Investigators:Drs. Bryan Springer, Thomas Fehring, William Griffin, Bo Mason, Walt Beaver, Thomas McCoy, Dan Uri
Objective:The purpo of this study is to determine if an investigational blood-thinning drug called YM150 is safe and effective for the prevention of deep vein thrombosis (when blood clots
form in your veins) in subjects following knee arthroplasty (knee joint replacement). Title: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing System, Smith & Nephew
腰疼拔罐管用吗
Investigator:John Masonis, MD
Objective: To evaluate the longer-term safety and effectiveness of the BHR system.
Title: A Randomized, Controlled, Multi-Center Pivotal Clinical Trial to Evaluate the Saefty and Effectiveness of GEM OS1 compared to autologous bohe graft (ABG) as a bone
regeneration device in foot and ankle fusions. Biomimetic Therapeutics Investigators: Drs. Robert Anderson, Bruce Cohen, Carroll Jones, and W. Hodges Davis
Objective: Demonstate equiv alent clinical and radiologic outcomes as “gold standard” (ABG) in a reprentative clinical model (foot and ankle fusions)
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Title: A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate degenerative Lumbar Spinal Stenosis
Investigators:Drs. Bruce Darden, Eric Laxer, Leo Spector, Alden Milam, Al Rhyne
Objective:The purpo of this study is to asss the effectiveness and the safety of the In-Space device compared to the X STOP Interspinous Process Distr action device (X STOP)
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 purpo 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
us ultrasound to help the healing of injured bones.
Anticipated start date: October 2008番茄炒鸡蛋图片
Studies Clod to Enrollment (Long-term follow-up):
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 Dia (SCDD). [FDA-Device
clinical trial] 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 dia by reducing the pain and neurological signs and
symptoms, without fusing the vertebrae.
Title:Study of Percutaneous Intradiscal Nucleoplasty Efficacy
[FDA-Device clinical trail] ArthoCare
申请表英文
Investigator:Sam Bhagia, MD
Objective:Compare the percutaneous disc decompression procedure using Coblation technology (DISC Nucleoplasty procedure) to lective nerve root injections (SNRI) for the treatment
of patients with radicular pain by evaluating treatment of efficacy and rate of
improvement in symptoms. This study will also compare the DISC Nucleoplasty to
Selective Nerve root injection.
Title:Multicenter Trial of the LPS-Flex Mobile Bearing Knee (Protocol #00-300)
Investigators:Thomas H. McCoy, MD; Walter B. Beaver, MD硬笔行书
Objective: To evaluate the safety and efficacy of the LPS-Flex Mobile Bearing Knee bad on a total of five study end point metrics:
1.Survivorship
2.Selected Radiographic Parameters
3.Knee Society function score
4.Knee Society Asssment score
5.Knee-related adver events or unanticipated device effects
6.Complication profiles of the investigational group with the control group
Study will be clod in October 2008; site will participate in a post-market study and w ill recruit
the same study patients and ask them to extend follow-up from 2 year to 10 years)
斯巴达克斯结局Title: Multicenter Study of Columbia Shoulder System
Investigators: Patrick M. Connor, MD
Objective: To determine tho aspects of the shoulder prosthesis and shoulder system which meet objective criteria for successful shoulder arthroplasty. The data will be ud to access
whether further improvements may be made upon completion of the study, through design
modifications.
Title: Performance of the Implex Hedrocel Ceramic Bearing Total Hip Replacement (THR) System in Primary Total Hip Arthroplasty (THA) [FDA-controlled Pha III clinical trial] Investigators: John Masonis, MD
Objective: To evaluate the outcome of the Hedrocel Ceramic Bearing THR System wh en ud as indicated for total hip arthroplasty (THA) in patients with vere degeneration, trauma,
or other pathology of the hip joint.
追风筝的人小说Title: Randomized, MultiCenter, Trial of Cermic on Metal-Hip replacement device
[FDA-Device clinical trial]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.
Humanitarian Device Exemption (HDE) Studies
A Humanitarian U Device is a device ud to diagno or treat a dia 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 u of Humanitarian Devices bad primarily on evidence that it does not po 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 u.
Finger
Title: HDE: U of the Ascension PIP Finger Implant
Investigators:Drs. Lois Osier, Paul Perlik, John Gaul, David Baker, and James Boatright (Presbyterian) Drs. James Boatright, Alan Ward, Erika Lumsden, Forney Hutchinson (Carolinas
Healthcare System)
Objective:The Ascension PIP is allowed by Federal law for u 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 u as a Humanitarian
U Device (HUD).
Thoracic (Chest)/Rib
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 u 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 u has not been demonstrated.
