Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.

Detailed Description
-----------------
This pivotal clinical trial was conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc devices were implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (NCT00642876) were compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.

Official Title
-----------------
A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease

Conditions
-----------------
Cervical Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: PRESTIGE® LP Cervical Disc
* Device: ATLANTIS Anterior Cervical Plate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history: a) herniated disc; b) osteophyte formation One level requiring surgical treatment C3-C4 disc to C6-C7 disc level involvement Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of cord compression No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level. Preop Neck Disability index score ≥ 30 Preop Neck Pain score of ≥ 20 based on the Preop Neck & Arm Pain Questionnaire Not pregnant at time of surgery Willing and able to comply with study plan and able to understand and sign patient informed consent Exclusion Criteria: Any other cervical spinal condition requiring surgical treatment at the involved level Documented or diagnosed cervical instability defined by radiographs showing Sagittal plane translation > 3.5mm or Sagittal plane angulation > 20 degrees. More than one cervical level requiring surgery A fused level adjacent to the level to be treated Severe pathology of the facet joint of involved bodies Previous surgery at the involved level Previously diagnosed osteopenia or osteomalacia Any of the following that may be associated with an osteoporosis diagnosis (if Yes to any of these, a DEXA Scan will be required to determine eligibility) Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture Male over the age of 70 Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or lower with the vertebral crush fracture, then the patient is excluded. Presence of spinal metastases Overt or active bacterial infection, either local or systemic Severe insulin dependent diabetes Chronic or acute renal failure or history of renal disease Temperature > 101º F oral at surgery Documented allergy to stainless steel, titanium or a titanium alloy Mentally incompetent Is a prisoner Is pregnant Is an alcohol and/or drug abuser Has received drugs which may interfere with bone metabolism within 2 weeks prior to the planned surgery date (steroids, methotrexate), excluding routine preop anti-inflammatories) A history of endocrine or metabolic disorder known to affect osteogenesis A condition that requires postop medications that interfere with the stability of the implant (steroids). This does not include low dose aspirin therapy. Received treatment with an investigational therapy within 28 days prior to surgery or planned for 16 weeks following implantation.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational<br>PRESTIGE® LP Cervical Disc | Device: PRESTIGE® LP Cervical Disc<br>* The PRESTIGE® LP Cervical Disc was inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.<br>* Other names: PRESTIGE® LP;|
| Active Comparator: Control<br>Control patients who received a ACDF fusion treatment from a previous IDE trial (NCT00642876) | Device: ATLANTIS Anterior Cervical Plate<br>* Anterior cervical discectomy and fusion with ATLANTIS plate for control group<br>* Other names: ATLANTIS plate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Overall Success | Rate of overall success is reported as the percentage of participants who met all of the following criteria: Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative; Maintenance or improvement in neurological status; Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of Postoperative Height - 6 Week Postoperative Height ≥ -2mm; No serious adverse event classified as implant associated or implant/surgical procedure associated; and No secondary surgical procedure classified as a failure. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate of Neck Disability Index | Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15. | 24 months | 
| Success Rate of Neurological Status | Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated. | 24 months | 
| Rate of Disc Height Success | Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm | 24 months | 
| Neck Pain Success Rate | Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0. | 24 months | 
| Arm Pain Success Rate | Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0. | 24 months | 
| Success Rate of SF-36 PCS | Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS. | 24 months | 
| Success Rate of SF-36 MCS | Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS. | 24 months | 
| Gait Success Rate | Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success. | 24 months | 
| Operative Time | Operative time was recorded from skin incision to wound closure. | Time of operation, approximately 1.5 hrs. | 
| Blood Loss |  | During the time of operation, approximately 1.5 hours. | 
| Hospital Stay |  | During the time of hospital stay, average of 1 day. | 
| Rate of Secondary Surgery at Index Level | Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of patients who had secondary surgeries at index level. | 24 months post-operation | 
| Change of Neck Disability Index Score From Baseline | The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline. | Baseline and 24 months post-operation | 
| Change of Neck Pain Score From Baseline | Numerical rating scales were used to evaluate neck pain intensity and frequency. Patients rated their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score (0 to100) was the product of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline. | Baseline and 24 months post-operation | 
| Change of Arm Pain Score From Baseline | Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 100) was the product of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline. | Baseline and 24 months post-operation | 
| Change of General Health Status -- SF-36 PCS From Baseline | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline. | Baseline and 24 months post-operation | 
| Change of General Health Status -- SF-36 MCS From Baseline | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline. | Baseline and 24 months post-operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical Disc