CLINICAL TRIALS

More than a center for excellence, the Andrews Research & Education Foundation (AREF) brings together the highest level of sports medicine researchers and medical professionals. This collaboration delivers opportunities on many levels. We partner with industry leaders to research cutting edge solutions that impact the future of sports medicine. In collaboration with the Andrews Institute, a world class epicenter for orthopaedics and sports medicine in Northwest Florida, and under the leadership of nationally and internationally renowned orthopedic surgeon James Andrews, MD, AREF has further secured Northwest Florida as a cradle for musculoskeletal treatments and research.

The Andrews Institute is comprised of several divisions including: Multi-specialty Ambulatory Surgery Center, Outpatient Rehabilitation, Diagnostic Imaging Center, Athletic Performance Center, Andrews Research & Education Foundation, and a multispecialty office park for physicians. The Andrews Institute is located on property contiguous to the Gulf Breeze Hospital in Gulf Breeze, Florida. The Andrews Institute, which has orthopaedic and sports medicine specialty physicians along with a Sports Medicine Fellowship, has attracted national and international attention to the area for its superior medical care in orthopaedics and research.

Physician specialties within Andrews Institute include Orthopaedic/Sports Medicine, Pain management, Neurosurgery, Neuroscience, Ophthalmology, Plastic Surgery, Orthodontics, Podiatry and General and Vascular Surgery. We deliver our evidence based content on many levels including; webinars, seminars, conferences, and on-site training. We welcome opportunities to partner with industry leaders to bring new and groundbreaking solutions to sports medicine.

 

For More Information: 850-916-8591

“Working with the research team at the Andrews Research & Education Foundation has been a true pleasure. Their professional while friendly approach makes communicating with the team enjoyable and productive. They understand and respect the meaningful details required for ensuring regulatory and protocol compliance which results in confidence that our research project is being managed properly. Exactech truly appreciates the work they do, and look forward to engaging in future projects.”
– Matthew Peterson, PhD, Senior Clinical Project Manager, Exactech, Inc.

Investigator – Christopher O’Grady, MD

Study Sponsor – Rotation Medical

Study Title – Rotation Medical Bioinductive Implant Database (REBUILD) Registry

Study Description -The purpose of this registry is to evaluate how shoulder function and quality of life change over time after shoulder surgery using the Rotation Medial Bioinductive Implant.


Investigator – Roger Ostrander, MD

Study Sponsor – Orthofix Inc.

Study Title – A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulsed Electromagnetic Field (PEMF) Therapy as an Adjunctive Treatment to Surgical Repair of Full Thickness Rotator Cuff Tears

Study Description -The goal of this study is to define a reduction in re-tear rates in subjects adjunctively treated with PEMF compared with those treated with a placebo (inactive) RCStim PEMF device following surgical repair of full thickness rotator cuff tears at 12 months post-op, as well as, demonstrate an increase in strength and a decrease in pain in PEMF treated subjects compared with placebo-treated subjects.

Investigator – Adam Anz, MD

Study Sponsor – KLSMC

Study Title – A multicenter, randomized, open-label, standard treatment-controlled parallel group phase 2 study to evaluate efficacy and safety of intra-articular injections of autologous peripheral blood stem cells and hyaluronic acid adjuvant therapy following subchondral drilling surgery for the treatment of articular cartilage injury in the knee with an optional open-label extension for the standard treatment-controlled group

Study Description – To evaluate the effect of intra-articular injections of peripheral blood stem cells together with hyaluronic acid after subchondral drilling surgery and postoperative physiotherapy on functional outcomes and pain of the knee joint relative to standard treatment.

Investigator – Joshua Hackel, MD

Study Sponsor – Emory University

Study Title – Randomized multicenter phase 3 single-blind trial comparing the efficacy of corticosteroid control to mesenchymal stem cell preparations from autologous bone marrow concentrate (BMAC), adipose derived stem cells in the form of Stromal Vascular Fraction (SVF), and third party human mesenchymal stem cells manufactured from umbilical cord tissue (UCT) for the treatment of unilateral Knee Osteoarthritis (OA). (MILES Study)

Study DescriptionThe goal of this study is to identify a superior source of stem cells for the treatment of osteoarthritis and validate its advantages over corticosteroid injections as traditional gold standard treatment. The primary efficacy co-outcomes are: a change in the visual analog score (VAS) pain score and a change in the knee injury and osteoarthritis outcome (KOOS) score. Secondary endpoints include Magnetic Resonance Imaging (MRI) and additional patient reported outcomes (PROs).


Investigator – Adam Anz, MD

Study Sponsor – In-House

Study Title – The Effect of Different Injection Regimens of Autologous Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis

Study Description – The purpose of this study is to determine if Hyaluronic Acid injected at the same time as Autologous Conditioned Plasma (ACP), a platelet rich plasma product, will improve the performance of ACP in the treatment of symptomatic knee osteoarthritis.

Investigator – Christopher O’Grady, MD

Study Sponsor – Zimmer Biomet

Study Title – Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study

Study Description – The objectives of this study are to confirm the safety and performance on the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Baseplate and/or Comprehensive Mini Humeral Tray in primary and revision reverse shoulder arthroplasty. Rates will be compared to observed rates in the literature for both competitive products and bone grafting used for glenoid erosion. Ultimately, clinical performance will be assessed through this PMCF using various outcome measures including radiolucencies, scapular notching, American Shoulder and Elbow Surgeon (ASES) Patient Questionnaire, and shoulder range of motion (ROM).