Florida Orthopaedic Institute is one of multiple study sites in the Centinel Spine, LLC, Multicenter, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of prodisc® C SK and prodisc® C Vivo to the Mobi-C® Cervical Disk in the Treatment of Two-Level Symptomatic Cervical Disk Disease (SCDD).
The prodisc products being used in the trial are built on the prodisc technology platform, the most widely used Total Disk Replacement system in the world. No other disk replacement system has been studied more—with over 13,000 patients reported on in more than 540 articles throughout a global clinical usage period of 30+ years. The prodisc technology has been validated with almost 225,000 device implantations and a reported reoperation rate of less than 1%. The prodisc C Vivo has been used outside the US for over 10 years, and the prodisc C SK device is an evolution of the original prodisc C, with a smaller keel design.
The Mobi-C (Zimmer Biomet) is FDA-approved for 1- and 2-level use. The prodisc systems are being investigated for approval by the FDA for 2-Level use.
Enrolled patients will be evaluated before surgery, as well as after surgery (2 and 6 weeks, 3-, 6-, 12- and 24 months)—with each visit taking approximately 1-2 hours. After the 2-year visit, patients return annually for follow-up visits for 5 years. Approximately 20 patients will be included in the study at Florida Orthopaedic Institute, with a minimum of 390 in the study overall. Patients with appropriate indications should review their condition with their doctor to determine if involvement in the clinical trial is appropriate.
ARE YOU A POTENTIAL CANDIDATE FOR THE TRIAL?
Potential participation in the trial would consider the following factors:
- You have arm/hand/shoulder pain or neurological symptoms such as numbness or weakness with or without neck pain.
- You have tried at least six weeks of nonsurgical care, such as physical therapy or medication or have symptoms that are getting progressively worse.
- A physician has indicated that you may need neck surgery to treat your symptoms.
- You are willing to undergo spine surgery. (This is a surgical procedure.)
- You have not had a previous fusion or total disk replacement surgery on your neck.
PARTICIPATING SURGEONS:
- Brooks R. Osburn, MD
- Adil Samad, MD
- John Small, MD
- Steven Tresser, MD
CONNECT WITH OUR RESEARCH TEAM TO SEE IF YOU QUALIFY TO PARTICIPATE OR ASK YOUR DOCTOR AT YOUR NEXT APPOINTMENT.
If you are interested in participating in this study, you can email the study team at:
ClinicalResearch@FOREonline.org and put “Centinel Spine” in the subject line.
You can also call or email the research coordinator directly:
Debbi Warren
dwarren@foreonline.org
813-978-9700, x 6766
For more information about the clinical trial, including inclusion/exclusion criteria, please visit https://clinicaltrials.gov/ct2/show/NCT04012996

Specialties
- AC Joint Injuries
- Achilles Tendinitis - Achilles Insertional Calcific Tendinopathy (ACIT)
- Achilles Tendon Rupture
- Achilles Tendonitis
- ACL Injuries
- Ankle Fracture Surgery
- Ankle Fractures (Broken Ankle)
- Ankle Fusion Surgery
- Anterior Cervical Corpectomy & Discectomy
- Arthroscopic Articular Cartilage Repair
- Arthroscopic Chondroplasty
- Arthroscopic Debridement of the Elbow
- Arthroscopy Of the Ankle
- Articular Cartilage Restoration
- Artificial Disk Replacement (ADR)
- Aspiration of the Olecranon Bursa
- Atraumatic Shoulder Instability
- Avascular Necrosis (Osteonecrosis)
- Bankart Repair
- Basal Joint Surgery
- Bicep Tendon Tear
- Bicep Tenodesis
- Bone Cement Injection
- Bone Growth Stimulation
- Bone Health Clinic
- Broken Collarbone
- Bunions
- Bursitis of the Shoulder (Subacromial Bursitis)
- Calcific Tendinitis of the Shoulder
- Carpal Tunnel Syndrome
- Charcot Joint
- Chiropractic
- Clavicle Fractures
- Colles’ Fractures (Broken Wrist)
- Common Foot Fractures in Athletes
- Community Outreach
- Cubital Tunnel Syndrome
- De Quervain's Tenosynovitis
- Degenerative Disk Disease
- Diffuse Idiopathic Skeletal Hyperostosis (DISH)
- Discectomy
- Discitis Treatment & Information
- Dislocated Shoulder
- Dupuytren’s Disease
- Elbow
- Elbow Bursitis
- Elbow Injuries in Throwing Athletes
- Epidural Injections for Spinal Pain
- Finger Dislocation
- Flexor Tendonitis
- Foot Stress Fractures
- Foot, Ankle & Lower Leg
- Foraminotomy
- Fractured Fingers
- Fractures Of The Shoulder Blade (Scapula)
- Fractures Of The Tibial Spine
- Functional Nerve Transfers of The Hand
- Ganglion Cysts
- General Orthopedics
- Glenoid Labrum Tear
- Golfer's Elbow
- Groin Strains and Pulls
- Growth Plate Injuries Of The Elbow
- Hallux Rigidus Surgery - Cheilectomy
- Hammer Toe
- Hamstring Injuries
- Hand & Finger Replantation
- Hand & Wrist
- Hand Nerve Decompression
- Hand Skin Grafts
- Hand, Wrist, Elbow & Shoulder
- Heat Injury/Heat Prostration
- High Ankle Sprain (Syndesmosis Ligament Injury)
- Hip & Thigh
- Hip Arthroscopy
- Hip Dislocation
- Hip Flexor Strains
- Hip Fractures
- Hip Hemiarthroplasty
- Hip Impingement Labral Tears
- Hip Muscle Strains
- Hip Pointers and Trochanteric Bursitis
- Hyperextension Injury of the Elbow
- Iliopsoas Tenotomy
- Iliotibial Band Syndrome
- Impingement Syndrome of the Shoulder
- Interlaminar Implants
- Interlaminar Lumbar Instrumental Fusion: ILIF
- Interventional Pain Management
- Interventional Spine
- Intraarticular Calcaneal Fracture
- Joint Replacement
- Knee & Leg
- Kyphoplasty (Balloon Vertebroplasty)
- Kyphosis
- Labral Tears Of The Hip (Acetabular Labrum Tears)
- Laminectomy: Decompression Surgery
- Lateral Collateral Ligament (LCL) Injuries
- Lisfranc Injuries
- Little League Shoulder
- LITTLE LEAGUER'S ELBOW (MEDIAL APOPHYSITIS)
- Lumbar Epidural Steroid Injection
- Lumbar Interbody Fusion (IBF)
- MACI
- Mallet, Hammer & Claw Toes
- Medial Collateral Ligament Injuries
- Meniscus Tears
- Metatarsalgia
- Minimally Invasive Spine Surgery
- Morton’s Neuroma
- Muscle Spasms
- Nerve Pain
- Neuromas (Foot)
- Neurosurgery
- Olecranon Stress Fractures
- Orthopaedic Total Wellness
- Orthopedic Physician Or A Podiatrist?
- Orthopedic Trauma
- Osteoarthritis of the Hip
- Osteoporosis
- Outpatient Spine Surgery
- Partial Knee Replacement
- Patellar Fracture
- Pelvic Ring Fractures
- Peripheral Nerve Surgery (Hand) Revision
- Pinched Nerve
- Piriformis Syndrome
- Piriformis Syndrome
- Plantar Fasciitis
- Podiatry
- Primary Care Sports Medicine
- Quadriceps Tendon Tear
- Radial Tunnel Syndrome (Entrapment of the Radial Nerve)
- Revascularization of the Hand
- Reverse Total Shoulder Replacement
- Rheumatoid Arthritis (RA) of the Shoulder
- Rheumatoid Arthritis Of The Hand
- Robotics
- Rotator Cuff Tears
- Runner's Knee
- Sacroiliac Joint Pain
- Sciatica
- Scoliosis
- Shin Splints
- Shoulder
- Shoulder Arthritis
- Shoulder Arthroscopy
- Shoulder Injury: Pain In The Overhead Athlete
- Shoulder Replacement
- Shoulder Separations
- Shoulder Socket Fracture (Glenoid Fracture)
- SLAP Tears & Repairs
- Spinal Fusion
- Spine
- Spondylolisthesis and Spondylolysis
- Sports Foot Injuries
- Sports Hernias (Athletic Pubalgia)
- Sports Medicine
- Sports Wrist and Hand Injuries
- Sprained Ankle
- Sprained Wrist Symptoms and Treatment
- Subacromial Decompression
- Sudden (Acute) Finger, Hand & Wrist Injuries
- Targeted Muscle Reinnervation (TMR)
- Tendon Transfers of The Hand
- Tennis Elbow
- Thigh Fractures
- Thigh Muscle Strains
- Thumb Ulnar Collateral Ligament Injuries
- Total Ankle Replacement
- Total Hip Arthroplasty
- Total Hip Replacement - Anterior Approach
- Total Knee Replacement Surgery
- Trapezius Strain (Muscle Strain of The Upper Back)
- Traumatic Shoulder Instability
- Triceps Tendonitis
- Trigger Finger
- Turf Toe
- UCL (Ulnar Collateral Ligament) Injuries
- Ulnar Neuritis
- Valgus Extension Overload
- Vertebroplasty
- WALANT (Wide Awake Local Anesthesia No Tourniquet)
- Whiplash and Whiplash Associated Disorder (WAD)
- Wound Care
- Wrist Arthroscopy
- Wrist Fractures
- Wrist Tendonitis
Services
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