Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD).

Official Title
-----------------
A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc-C to Anterior Cervical Discectomy and Fusion (ACDF) Surgery in the Treatment of Symptomatic Cervical Disc Disease (SCDD)

Conditions
-----------------
Symptomatic Cervical Disc Disease

Intervention / Treatment
-----------------
* Device: Total Disc Replacement
* Device: ACDF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7 defined as: Neck or arm (radicular) pain; and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI or X-rays): Herniated nucleus pulposus; Spondylosis (defined by the presence of osteophytes); and/or Loss of disc height. Age between 18 and 60 years. Unresponsive to non-operative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment. NDI score greater than or equal to 15/50 (30%). Psychosocially, mentally and physically able to fully comply with the protocol including adhering to follow-up schedule and requirements and filling out forms. Signed informed consent. Exclusion Criteria: More than one vertebral level requiring treatment. Marked cervical instability on resting lateral or flexion/extension radiographs: translation greater than 3mm and/or greater than 11 degrees of rotational difference to that of either adjacent level. Has a fused level adjacent to the level to be treated. Radiographic confirmation of severe facet joint disease or degeneration. Known allergy to cobalt, chromium, molybdenum, titanium or polyethylene. Clinically comprised vertebral bodies at the affected level(s) due to current or past trauma, e.g. by the radiographic appearance of fracture callus, malunion or nonunion. Prior surgery at the level to be treated. Severe spondylosis at the level to be treated as characterized by any of the following: Bridging osteophytes; A loss of disc height greater than 50%; or Absence of motion (<2°). Neck or arm pain of unknown etiology. Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA (dual energy x-ray absoptiometry) bone mineral density measurement. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score less than or equal to -2.5 (the World Health Organization definition of osteoporosis). Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above). Severe diabetes mellitus requiring daily insulin management. Pregnant or interested in becoming pregnant in the next three years. Active infection - systemic or local. Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids). Rheumatoid arthritis or other autoimmune disease. Systemic disease including AIDS, HIV, hepatitis. Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProDisc-C<br>ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 | Device: Total Disc Replacement<br>* Total Disc Replacement using ProDisc-C<br>* Other names: ProDisc-C;|
| Active Comparator: Control<br>ACDF | Device: ACDF<br>* Anterior Cervical Discectomy and Fusion<br>* Other names: Control;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Success | Sponsor Definition of Overall Success: (1) Subject's NDI score improved by at least 20% over preoperative baseline value (2) Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value (3) No removals, revisions, re-operations, or additional fixation were required to modify any implant (4) No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material | 84 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic Success | % of subjects who were a neurological success (i.e. the patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value) | 84 months | 
| NDI | NDI is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation and is the most commonly used self-report measure for neck pain. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale (0='No pain' and 5='Worst imaginable pain'). The points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage: 0 points or 0% means no activity limitations, 50 points or 100% means complete activity limitation. Mean duration of the test is 3-8 minutes and the results can be interpreted as: 0-4 points (0-8%) no disability; 5-14 points (10-28%) mild disability; 15-24 points (30-48%) moderate disability; 25-34 points (50-64%) severe disability; 35-50 points (70-100%) complete disability | 84 months | 
| SF-36 Physical Composite Score (PCS) | The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. It can take patients at least half an hour to complete the SF-36. The Physical Composite Score (PCS) specifically looks at the mean average of all of the physically relevant questions. | 84 Months | 
| SF-36 Mental Composite Score (MCS) | The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. It can take patients at least half an hour to complete the SF-36. The Mental Composite Score (MCS) specifically looks at the mean average of all of the mental or emotional relevant questions. | 84 Months | 
| VAS Satisfaction | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of No Satisfaction [with the surgery/outcome] at 0mm and Complete Satisfaction [with the surgery/outcome] at 100mm. | 84 Months | 
| VAS Neck Pain Intensity | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of No [Neck] Pain at 0mm and Worst [Neck] Pain Possible at 100mm. | 84 Months | 
| VAS Neck Pain Frequency | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of None of the Time [Neck] Pain at 0mm and All of the Time [Neck] Pain at 100mm. | 84 Months | 
| VAS Arm Pain Intensity | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of No [Arm] Pain at 0mm and Worst [Arm] Pain Possible at 100mm. | 84 Months | 
| VAS Arm Pain Frequency | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of None of the Time [Arm] Pain at 0mm and All of the Time [Arm] Pain at 100mm. | 84 Months | 
| Surgery Again | % of subjects who would opt to have the surgery again if given the choice at 84 months | 84 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ProDisc, ProDisc-C, Spinal Fusion, Anterior cervical diskectomy, Cervical spine, Disc disease, Implant, Degenerative disc disease, Intervertebral disc