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: 850-916-8590

“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 – Matthew Mai, MD

Study Sponsor – Zimmer Biomet

Study Title – A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip

Study Description – The goal of this study is to collect data on the short- and long-term outcomes for subjects undergoing the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting. Outcomes to be assessed include medication usage, pain, function, activity levels and patient satisfaction.

Investigator – Brett Kindle, MD

Study Sponsor – Samumed

Study Title – A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

Study Description – The objective of this study is to determine the efficacy, safety, and tolerability of the SM04690 Injectable Suspension 0.07 milligram (mg) dose in the treatment of knee osteoarthritis (OA).


Investigator – Joshua Hackel, MD

Study Sponsor – Emory University

Study Title – Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES)

Study Description – 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). The 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.

Investigator – Joshua Hackel, MD

Study Sponsor – Ingeneron, INC

Study Title: Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

Description: The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.


Investigator – Adam Anz, MD

Study Sponsor – Arthrex

Study Title – Arthrex Demineralized Bone Matrix

Description -This study is a randomized control trial assessing outcomes after augmentation of rotator cuff repair (RCR) with demineralized bone matrix (DBM).


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 – Arthrex

Study Title – Optimized Bone Marrow Aspirate Concentrate

Study Description – The investigation compares the cellular makeup of bone marrow aspirate from deep humeral harvest versus bone marrow aspirate from the posterior iliac crest harvest. These bone marrow aspirate harvests occur in patients undergoing rotator cuff repair.

Investigator – Adam Anz, MD

Study Title – Effect of Platelet Rich Plasma Injections on Inflammatory and Chondrodegenerative Biomarkers in Patients with Acute ACL Tears

Study Description – The purpose of this investigation is to test the effectiveness of aspiration and PRP injection following ACL tear comparative to only aspiration and no injection following the ACL tear.


Investigator – Adam Anz, MD

Study Sponsor – Arthrex

Study Title – Quantification of Stem Cells in Anterior Cruciate Ligament Stump, Synovial Fluid, Fat Pad, Bone Debris, and Cartilage Debris during Surgery

Study Description – The aim of this study is to further develop affordable, autologous biologic augmentation of ACL reconstruction. The objectives of this study are to 1) compare stem cell and cell counts between the ACL stump, fat pad, bone debris, cartilage debris, and platelet-rich plasma and 2) determine if the GraftNet and thrombinator can be used in combination to produce a reproducible and effective autologous biologic augmentation technique.

Investigator – Adam Anz, MD

Study Title – Effects of Blood Flow Restriction Compared to Standard Rehabilitation in Patients Following Glenoid Labral Repair

Study Description – The purpose of this investigation is to compare the difference in patient reported outcomes (PRO’s) following glenoid labral repair in patients that received blood flow restriction (BFR) during physical therapy versus patients who did not received BFR during physical therapy.