RESEARCH – MULTI-CENTER AND ONGOING TRIALS
FDA Studies Open to Enrollment:
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
FDA Studies Closed to Enrollment (Long-term follow-up):
Title: A Phase 3b Open-Label Historically-Controlled Study to Assess The Safety And Efficacy Of Two Concurrent
Injections Of AA4500 In Adult Subjects With Multiple Dupuytren’s Contractures With Palpable Cords
Sponsor: Auxilium
Investigators: Drs. Perlik, Gantt, Osier, Baker, Ward, Chadderdon, Gaston, Lewis, Gaul, and Boatright
Objective: To assess the safety and efficacy of the simultaneous administration of two injections of AA4500 (Xiaflex) into
the same hand with multiple Dupuytren’s contractures caused by palpable cords followed 24 to 72 hours later by a finger
extension procedure.
Grants:
American Society for Surgery of the Hand
"Lymphedema Following Elective Hand and Wrist Surgery in Women who are Post Axillary Lymph Node Dissection; A
prospective, randomized, clinical trial"
Principal Investigator: R. Glenn Gaston, MD
Other Institutions: Indiana Hand Center, and The Hand and Upper Extremity Center of Georgia
Purpose: To determine the risks associated with upper hand or wrist surgery, with or without the use a tourniquet, in
patients who have previously had a mastectomy.
On-Going:
WRIST Study, NIH Funded prospective, multi-center, randomized study looking at the results of ORIF vs. ex-fix vs.
CRPP for distal radius fractures in the elderly. Lead investigator is Dr. Kevin Chung. Dr. Glenn Gaston serves as the
OrthoCarolina site P.I.