Clinical Trials

 

More than a center for excellence, the Andrews Research and 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 Institute is comprised of several divisions including: Multi-specialty Ambulatory Surgery Center, Outpatient Rehabilitation, Diagnostic Imaging Center, Athletic Performance Center, a Research and Education Institute, and a multispecialty office park for physicians. The 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, white papers, and on-site training. We welcome opportunities to partner with industry leaders to bring new and groundbreaking solutions to sports medicine.

“Working with the research team at the Andrew’s Institute 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 – Charles Roth, MD

Study Sponsor – LifeNet Health, Inc.

Study Title – Use of ArthroFlex, TM for Reconstruction of Massive or Recurrent Rotator Cuff Tears

Study Description – This study will test the effectiveness of a decellularized skin graft in the treatment of massive or recurring rotator cuff tears.

*This study is no longer enrolling patients


Investigator – James Andrews, MD

Study Sponsor – Pacira Pharmaceuticals

Study Title – The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics

Study Description -The purpose of this study is to determine if the product EXPAREL®, can be used as a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and providing appropriate postoperative pain control.


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 – Christopher O’Grady, MD

Study Sponsor – ArthroCare

Study Title – A Prospective, Double Blinded, Multi-Center, Randomized, Controlled Trial to Evaluate Mechanical Debridement vs. Radiofrequency-Based Debridement in the treatment of Articular Cartilage Lesions.

Study Description – This study will evaluate 2 different treatments, Radiofrequency-Based Debridement or Mechanical Debridement, to treat knee cartilage lesions.

Investigator – Adam Anz, MD

Study Sponsor – Ceterix Orthopaedics,Inc.

Study Title – A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears (STITCH Study).

Study Description – This study will document whether a horizontal meniscus tear can hold together and heal if it is repaired with stitches. This study will also document any changes in knee pain and function after the procedure.

Investigator – Brett Kindle, MD, Adam Anz, MD, Joshua Hackel, MD, Michael Milligan, MD, & Roger Ostrander, MD

Study Sponsor – Zimmer Biomet

Study Title – A Multicenter, Double-Blind, Randomized, Saline-Controlled Study of a Single, Intra-Articular Injection of Autologous Protein Solution in Patients with Knee Osteoarthritis

Study Description – A double-blind, multicenter, randomized, saline-controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with symptomatic osteoarthritis (OA) of the knee who have not been able to get satisfactory pain relief with prior treatment.


Investigator – Joshua Hackel, MD

Study Sponsor – EmCyte

Study Title – Efficacy of bone marrow aspirate concentrate compared with platelet rich plasma for the treatment of symptomatic knee osteoarthritis: A randomized, controlled clinical trial.

Study Description – This study is to compare the effectiveness of bone marrow aspirate concentrate (BMA) to platelet rich plasma (PRP) injections for the treatment of knee osteoarthritis.


Investigator – Joshua Hackel, MD & Dax Steele, MD

Study Sponsor – OrthoCor

Study Title – A prospective, double blind, placebo controlled study on patient satisfaction outcomes with the use of an Orthocor PEMF treatment for osteoarthritis.

Study Description – The purpose of this study is to determine the effects of the OrthoCor PEMF (pulsed electromagnetic field) brace on knee pain and function in osteoarthritis patients.

*This study is no longer enrolling patients


Investigator – Joshua Hackel, MD

Study Sponsor – AMSSM

Study Title – Practical Indications for Sonography in Musculoskeletal Medicine- Knee Joint Injections (PRISMM-Knee).

Study Description – To determine the most accurate and clinically effective way to inject the knee joint by comparing the two most commonly performed intra-articular injection techniques with or without ultrasound guidance.


Investigator – Christopher O’Grady, MD

Study Sponsor – Flexion Therapeutics, Inc.

Study Title – An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee

Study Description – This study is an open-label, repeat administration design of 40 mg FX006. The study will be conducted in male and female patients ≥ 40 years of age with symptomatic OA of the knee.

Investigator – James Andrews, MD

Study Sponsor – Gensco

Study Title – The Effect of SpeedGel Rx on Postsurgical Pain, and the use of Narcotics.

Study Description – The purpose of this study is to find out if an herbal topical gel called SpeedGel RX will help lessen pain after knee ACL surgery.

Investigator – Michael Hartsfield, MD

Study Sponsor – Exactech, Inc.

Study Title – A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak® Knee System

Study Description – The purpose of this study is to collect prospective and retrospective clinical outcomes data to further affirm the safety and effectiveness of the Optetrak® Knee System product lines.

Investigator – Erik Nilssen, MD

Study Sponsor – AOFAS

Study Title – Clinical and biomechanical outcomes following gastrocnemius recession vs. fasciotomy for plantar fasciitis.

Study Description – This study compares the gastrocnemius recession to a plantar fasciotomy in patients with plantar fasciitis.