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.


Current Clinical Trials At Andrews Research & Education Foundation:
Condition
Investigator
Study Sponsor
Plantar Fasciitis
Erik Nilssen, MD
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.
Condition
Investigator
Study Sponsor
Rotator Cuff Tears
Charles Roth, MD
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.
Condition
Investigator
Study Sponsor
Cartilage Lesions of the Knee
Christopher O’Grady, MD
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.
Condition
Investigator
Study Sponsor
Bone Marrow Aspirate
Adam Anz, MD
Celling BioSciences
Study Title:
Evaluation of Synovial Stem Cell Content after Knee Injury.
Study Description:
This study will evaluate the cell content collected from knee synovial fluid and fat pad during an arthroscopic surgery.
Condition
Investigator
Study Sponsor
Horizontal Meniscal Tear
Adam Anz, MD
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.
Condition
Investigator
Study Sponsor
Diabetic Wounds
Layne Yonehiro, MD
LifeNet Health,Inc.
Study Title:
A Multicenter, Randomized, Controlled, Open-Label Trial to Assess the Clinical Effectiveness of DermACELL®, Conventional Care Wound Management, and GraftJacket® in Subjects with Chronic Wounds in the Lower Extremities.
Study Description:
This study is designed to demonstrate the effectiveness of DermACELL compared to GraftJacket® in the treatment of chronic diabetic wounds.
Condition
Investigator
Study Sponsor
Frozen Shoulder
Joshua Hackel, MD
Dynasplint Systems, LLC
Study Title:
Outcomes Following Dynamic Splinting and/or Physical Therapy for Patients with Adhesive Capsulitis.
Study Description:
This study examines the effectiveness of a specific physical therapy protocol and/or dynamic splinting on patient pain, shoulder function and range of motion (ROM) for frozen shoulder/adhesive capsulitis.
Condition
Investigator
Study Sponsor
Knee Osteoarthritis
Joshua Hackel, MD
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.
Condition
Investigator
Study Sponsor
Knee Osteoarthritis
Dax Steele, MD
Joshua Hackel, MD
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.
Condition
Investigator
Study Sponsor
Knee Osteoarthritis
Joshua Hackel, MD
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.
Condition
Investigator
Study Sponsor
Rheumatoid Arthritis
Rachel Brown, MD
F. Hoffmann-La Roche Ltd.
Study Title:
A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA).
Study Description:
In this study we will compare the effects of TCZ compared to ETA on the occurrence of cardiovascular illness, including heart attacks, strokes, and death related to cardiovascular disease in patients with rheumatoid arthritis. Note: This study is no longer enrolling patients.
Condition
Investigator
Study Sponsor
Post-ACL Surgical Pain
James Andrews, MD
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.
Condition
Investigator
Study Sponsor
Knee Chondral Lesions
Charles Roth, MD
Zimmer, Inc.
Study Title:
A Stratified, Post-Market Study of DeNovo® NT for Treatment of Femoral and Patellar Articular Cartilage Lesions of the Knee.
Study Description:
The purpose of this study is to evaluate the effectiveness of DeNovo® NT Natural Tissue Graft to help heal cartilage damage of the knee.
Condition
Investigator
Study Sponsor
Knee Replacement
Michael Hartsfield, MD
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.