Medtronic 6982246 Instructions for Use
PRESTIGE™ CERVICAL DISC
Implant package contents (superior and inferior disc
components, bone screws, lock screws) provided sterile.
Instrument set contents provided non-sterile.
2017-02-15
0381252E Rev. C
IMPORTANT INFORMATION ON THE PRESTIGE™ CERVICAL DISC
DESCRIPTION
The PRESTIGE™ Cervical Disc is a two-piece articulating metal-on-metal device that is inserted into the intervertebral disc
space at a single cervical level using an anterior approach. The device is manufactured from wrought type 316 stainless steel
(ASTM F-138) and consists of two metal plates which function via a ball and trough mechanism. The superior component of the
implant contains the ball portion of the mechanism, and the inferior component incorporates the trough portion. The flat portion
of each component, which contacts the vertebral endplate, is roughened through a grit blasting process.
Each component is affixed to the vertebral body by two bone screws through an anterior flange. The bone screws are held in
place by a lock screw mechanism. In the implanted disc, the bone screws are divergent in the cephalic/caudal direction and
convergent in the medial/lateral direction.
The device assembly was designed to allow the following motions ex-vivo: a minimum of 10° motion off the neutral position in
flexion/extension and lateral bending, unconstrained axial rotation, and 2 mm of anterior/posterior translation.
The available components are shown in the table below.
Table 1: PRESTIGE™ Cervical Disc Device Configurations
Catalog Number Component Description
6961260 6 mm x 12 mm Disc Assembly
6961460 6 mm x 14 mm Disc Assembly
6961660 6 mm x 16 mm Disc Assembly
6961270 7 mm x 12 mm Disc Assembly
6961470 7 mm x 14 mm Disc Assembly
6961670 7 mm x 16 mm Disc Assembly
6961870 7 mm x 18 mm Disc Assembly
6961480 8 mm x 14 mm Disc Assembly
6961680 8 mm x 16 mm Disc Assembly
6961880 8 mm x 18 mm Disc Assembly
6960013/6961340* Self-Tap Bone Screw 4.0 mm x 13 mm
6960015/6961540* Self-Tap Bone Screw 4.0 mm x 15 mm
6960113/6961345* Self-Tap Bone Screw 4.5 mm x 13 mm
6960115/6961545* Self-Tap Bone Screw 4.5 mm x 15 mm
6960120/6961120* Lock Screw
* Catalog number for screws in implant box / catalog number for separately packaged extra screws, if needed.
Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog
or price list for further information about warranties and limitations of liability.
INDICATIONS
The PRESTIGE™ Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7
following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain,
or myelopathy due to a single-level abnormality localized to the disc space and at least one of the following conditions confirmed
by radiographic imaging (CT, MRI, X- rays): herniated nucleus pulposus and/or osteophyte formation. The PRESTIGE™ device
is implanted via an open anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to
implantation of the PRESTIGE™ Cervical Disc.
CONTRAINDICATIONS
The PRESTIGE™ Cervical Disc should not be implanted in patients with an active infection or with an allergy to stainless steel.
WARNINGS
The PRESTIGE™ Cervical Disc should only be used by surgeons who are experienced in the surgical procedure and have
undergone adequate training with this device. A lack of adequate experience and/or training may lead to a higher incidence of
adverse events, such as neurological complications.
Due to the proximity of vascular and neurological structures to the implantation site, there are risks of serious or fatal
hemorrhage and risks of neurological damage with the use of this device. Serious or fatal hemorrhage may also occur if the
great vessels are eroded or punctured during implantation and are subsequently damaged due to breakage of implants,
migration of implants, or if pulsatile erosion of the vessels occurs because of close apposition of the implants.
PRECAUTIONS
The safety and effectiveness of this device has not been established in patients with the following conditions:
▪ More than one cervical level with DDD;
▪ Not skeletally mature;
▪ Clinically significant cervical instability;
▪ Prior fusion at adjacent cervical level;
▪ Severe facet joint pathology of involved vertebral bodies;
▪ Prior surgery at treated level;
▪ Osteopenia, osteomalacia, or osteoporosis as defined by bone mineral density T-score of -3.5, or -2.5 with vertebral crush
fracture;
▪ Spinal metastases;
▪ Chronic or acute renal failure or history of renal disease;
▪ Taking medications known to potentially interfere with bone/soft tissue healing (e.g. steroids);
▪ Pregnant; and
▪ Severe insulin dependent diabetes.
In addition, safety and effectiveness of the device has not been established in patients who have not undergone at least six
weeks of conservative treatment or had signs of progression or spinal cord/nerve root compression with continued nonoperative care.
Implanted metal alloys release metallic ions into the body (especially those devices with metal-on-metal articulating surfaces).
The long term effect of these ions on the body is not known.
Wear rates higher than those predicted based on bench testing have been observed during in vivo wear analyses of several
explanted PRESTIGE™ Cervical Disc devices. In addition, there has been evidence of metallosis accompanied by a chronic
macrophage-dominated inflammatory response in subjects who have had the device removed. While there has been no direct
causal association between the wear-related findings and implant loosening/osteolysis, device failure or overall clinical
outcomes, high wear and associated metallosis and chronic inflammation are potential precursors of longer-term failure.
PRE-OPERATIVE
Patient selection is extremely important. In selecting patients for a total disc replacement, the following factors can be of
extreme importance to the success of the procedure: the patient’s occupation or activity level; a condition of senility, mental
illness, alcoholism or drug abuse; and certain degenerative diseases (e.g., degenerative scoliosis or ankylosing spondylitis) that
may be so advanced at the time of implantation that the expected useful life of the device is substantially decreased.
Correct selection of the appropriate implant size is extremely important to assure the placement and function of the disc. See
the surgical technique manual for step-by-step instructions.
INTRA-OPERATIVE
Use aseptic technique when removing the PRESTIGE™ Cervical Disc Replacement components from the innermost packaging.
Use care when handling a PRESTIGE™ component to ensure that it does not come in contact with objects that could damage
the implant. Exercise care to ensure that implantation instruments do not contact the highly polished articulating surfaces of the
endplates. Damaged implants are no longer functionally reliable.
To prevent unnecessary damage to the bearing surfaces, ensure that tissue debris is not trapped within the assembly.
PRESTIGE™ Cervical Disc Replacement components should not be used with components or instruments of spinal systems
from other manufacturers. See the surgical technique manual for step-by-step instructions.
Surgical implants must never be re-used or re-implanted. Even though the device appears undamaged, it may have small
defects and internal stress patterns that may lead to early breakage.
POST-OPERATIVE
Patients in the clinical study were instructed to use non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks
postoperatively. It has been reported in the literature that short-term postoperative use of NSAIDs may reduce the instance of
heterotopic ossification.
Patients should be instructed in postoperative care procedures and should be advised of the importance of adhering to these
procedures for successful treatment with the device, including the avoidance of heavy lifting, repetitive bending, and high-impact
exercise or athletic activity for 60 days postoperative.
POTENTIAL ADVERSE EVENTS
Risks associated with the use of the PRESTIGE™ Cervical Disc include: 1) those commonly associated with any surgery; 2)
those specifically associated with cervical spinal surgery using an anterior approach; and 3) those associated with a spinal
implant, as well as those pertaining to the PRESTIGE™ Cervical Disc. However, the causality of these adverse events is not
exclusive to these categories. There is also the risk that this surgical procedure will not be effective, and may not relieve or may
cause worsening of preoperative symptoms. Some of these effects may have been previously reported in the adverse events
table.
1. Risks associated with any surgical procedure are those such as abscess; cellulitis; wound dehiscence; wound necrosis;
edema; hematoma; heart and vascular complications; hypertension; thrombosis; ischemia; embolism; thromboembolism;
hemorrhage; thrombophlebitis; adverse reactions to anesthesia; pulmonary complications; organ, nerve or muscular
damage; seizure, convulsion, or changes to mental status; and complications of pregnancy including miscarriage and fetal
birth defects.
2. Risks associated with anterior interbody surgery of the cervical spine include dysphagia; dysphasia; dysphonia; hoarseness;
vocal cord paralysis; laryngeal palsy; sore throat; recurring aspirations; nerve deficits or damage; tracheal, esophageal, and
pharyngeal perforation; airway obstruction; external chylorrhea; warmth or tingling in the extremities; deficit or damage to
the spinal cord, nerve roots, or nerves possibly resulting in paralysis or pain; dural tears or leaking; cerebrospinal fistula;
discitis, arachnoiditis, and/or other types of inflammation; loss of disc height; loss of proper curvature, correction, height or
reduction of the spine; vertebral slipping; scarring, herniation or degeneration of adjacent discs; surrounding soft tissue
damage, spinal stenosis; spondylolysis; otitis media; fistula; vascular damage and/or rupture; and headache.
3. Risks associated with implants in the spine, including the PRESTIGE™ device, are early or late loosening of the
components; disassembly; bending or breakage of any or all of the components; implant migration; malpositioning of
implant; loss of purchase; sizing issues with components; anatomical or technical difficulties; implant fracture; bone fracture;
skin penetration, irritation, pain, bursitis resulting from pressure on the skin from component parts in patients with
inadequate tissue coverage over the implant; foreign body reaction to the implants including possible tumor formation,
autoimmune disease, metallosis, and/or scarring; possible tissue reaction; bone resorption; bone formation that may reduce
spinal motion or result in a fusion, either at the treated level or at adjacent levels; development of new radiculopathy;
myelopathy or pain; cessation of bone growth of the operated portion of the spine; tissue or nerve damage caused by
improper positioning and placement of implants or instruments; loss of neurological function; decreased strength of
extremities; decreased reflexes; appearance of cord or nerve root injury; loss of bowel and/or bladder control or other types
of urological system compromise; gastrointestinal and/or reproductive system compromise; and interference with
radiographic imaging because of the presence of the implant.
4. Wound, local, and/or systemic infections.
5. Surgical instrument bending or breakage, as well as the possibility of a fragment of a broken instrument remaining in the
patient.
6. Inability to resume activities of normal daily living, including loss of consortium.
7. Death.
NOTE: For the specific adverse events that occurred in the clinical study of the PRESTIGE™ Cervical Disc, please see
Safety Results in the CLINICAL STUDIES section below. Additional surgery may be necessary to correct some of the
adverse effects.
CLINICAL STUDIES
A multi-center, prospective, randomized, non-inferiority clinical trial of the PRESTIGE™ Cervical Disc was conducted in the
United States comparing the anterior spinal use of the PRESTIGE™ device to fusion using allograft and plating stabilization, the
control, in the treatment of patients with symptomatic degenerative disc disease for an Investigational Device Exemption (IDE)
(G010188). A total of 541 patients were enrolled in the clinical trial: 276 patients in the investigational PRESTIGE™ device
treatment group and 265 patients in the control arm. Fifty-nine additional continued access patients also received the
investigational treatment. Twenty-five of the continued access patients were simultaneously enrolled into a Metal Ion cohort, and
had blood collected for metal ion analysis at each follow-up time point.
A Post-Approval Study required as a condition of PMA approval was also conducted to follow the original IDE subject cohort
through 84 months postoperatively.
SUMMARY OF THE IDE AND POST-APPROVAL STUDY (PAS) METHODS
Study Objectives
IDE Study
The primary objective of the IDE study was to demonstrate that the overall success rate for the investigational PRESTIGE™
Cervical Disc treatment is statistically non-inferior to, the overall success rate of the control treatment at 24 months following
surgery as determined by a prespecified non-inferiority margin of 0.10. If statistical non-inferiority was established, the
investigational treatment is considered to be safe and effective and the study was considered a success.
Other secondary objectives were to compare the success rates of individual effectiveness endpoints and neurological status at
24 months following surgery.
PAS Study
The primary objective of the post-approval study was to demonstrate that the overall success rate for the investigational
PRESTIGE™ Cervical Disc treatment is statistically non-inferior to the overall success rate of the control treatment at 84 months
following surgery, as determined by a pre-specified non-inferiority margin of 0.10. If statistical non-inferiority was established,
the investigational treatment is considered to be safe and effective and the study was considered a success.
Other secondary objectives were to compare the success rates of individual effectiveness endpoints and neurological status at
84 months following surgery.
Study Designs
IDE Study
The IDE study was a multi-center, prospective, randomized, controlled clinical trial comparing the investigational PRESTIGE™
Cervical Disc treatment to the control treatment. Data were collected at pre-operative, discharge, 6 weeks, 3 months, 6 months,
12 months (1 year) and at 24 months (2 years).
PAS Study
The post-approval study was a prospective study to continue follow-up on the subjects who participated in the IDE study. Data
were collected at 36 months (3 years), 60 months (5 years), and 84 months (7 years) postoperative to determine the long-term
safety and effectiveness of the device.
Inclusion and Exclusion Criteria
Patient eligibility criteria were defined in the original IDE clinical study protocol. No exclusion of any patient was planned for the
post-approval study. As defined in the IDE study protocol, prospective patients were diagnosed with symptomatic cervical
degenerative disc disease according to the following inclusion/exclusion criteria. Patients were geographically stable and were
able to attend follow-up examinations at the investigational site. In addition, all patients agreed to undergo the necessary
preoperative and postoperative evaluations specified in the Clinical Investigational Plan (CIP).
Inclusion Criteria:
All patients participating in this study were required to meet all of the following inclusion criteria:
1. Cervical degenerative disc disease defined as: intractable radiculopathy and/or myelopathy with at least one of the following
characteristics and producing symptomatic nerve root and/or spinal cord compression as documented by patient history
{e.g., pain [neck and/or arm pain], functional deficit and/or neurological deficit, and radiographic studies (e.g., CT, MRI, xrays, etc.)}:
a) herniated disc
b) osteophyte formation
2. One cervical level requiring surgical treatment;
3. C3-C4 disc to C6-C7 disc level of involvement;
4. 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 continued non-operative management;
5. No previous surgical intervention at the involved level or any subsequent, planned/staged surgical procedure at the involved
or adjacent level(s);
6. At least 18 years of age at the time of surgery;
7. Preoperative Neck Disability Index score ≥ 30;
8. Preoperative neck pain score of > 20 (based on the Preoperative Neck and Arm Pain Questionnaire);
9. Not pregnant at the time of surgery;
10. Willing to comply with the study plan and sign the Patient Informed Consent Form.
Exclusion Criteria:
A patient meeting any of the following criteria was to be excluded from the study:
1. Cervical spinal condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level;
2. Documented or diagnosed cervical instability defined by dynamic (flexion/extension) radiographs showing:
a) Sagittal plane translation > 3.5 mm or;
b) Sagittal plane angulation > 20°;
3. More than one cervical level requiring surgical treatment;
4. Fused level adjacent to the level to be treated;
5. Severe pathology of the facet joints of the involved vertebral bodies;
6. Previous surgical intervention at the involved level;
7. Previously diagnosed with osteopenia or osteomalacia;
8. Any of the following that may be associated with a diagnosis of osteoporosis (if any of the below risk factors were present, a
DEXA Scan was required to determine eligibility, with a measured BMD of -3.5, or 2.5 with vertebral crush fracture,
considered a criteria for exclusion):
a) Postmenopausal non-black female over 60 years of age who weighs less than 140 pounds.
b) Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
c) Male over the age of 70.
d) Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.
9. Presence of spinal metastases;
10. Overt or active bacterial infection, either local or systemic;
11. Severe insulin dependent diabetes;
12. Chronic or acute renal failure or prior history of renal disease;
13. Fever (temperature > 101° F oral) at the time of surgery;
14. Documented allergy or intolerance to stainless steel, titanium, or a titanium alloy;
15. Mental incompetence. (If questionable, psychiatric consult was obtained);
16. Incarceration;
17. Pregnancy;
18. Alcohol and/or drug abuse, as defined by currently undergoing treatment for alcohol and/or drug abuse;
19. Use of drugs (e.g., steroids or methotrexate) which may interfere with bone metabolism within two weeks prior to the
planned date of spinal surgery (excluding routine perioperative anti-inflammatory drugs;
20. History of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget’s Disease, renal osteodystrophy,
Ehlers-Danlos Syndrome, or osteogenesis imperfecta);
21. Condition that requires postoperative medications that interfere with the stability of the implant or fusion, such as steroids.
(Excluding low dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs);
22. Treatment with an Investigational therapy within 28 days prior to implantation surgery, or plans for such treatment earlier
than 16 weeks following the study treatment.
Study Population
The studies included 541 enrolled IDE, continued access and metal ion study subjects who were at least 18 years old at the
time of the surgery and met the study inclusion and exclusion criteria.
Post-Operative Care
The recommended post-operative care included avoidance of heavy lifting, repetitive bending, and high-impact exercise or
athletic activity for 60 days postoperatively. Avoidance of prolonged NSAID use (beyond 2 weeks postop) was also specified in
the postoperative regimen, although the use of NSAIDs was recommended for the first two weeks postoperatively. The use of
electrical bone growth stimulators was prohibited during the 24-month follow-up period. Patients who smoked were also
encouraged to discontinue smoking.
IDE and PAS Follow-up Schedules
For the IDE study, patients were evaluated preoperatively (within 6 months of surgery), intraoperatively, and postoperatively at 6
weeks, 3, 6, 12, and 24 months. For the PAS study, patients were evaluated at 36, 60, and 84 months. At each evaluation time
point, the primary and secondary clinical and radiographic outcome parameters were evaluated as shown in Table 2. For the
IDE, success was determined from data collected during the initial 24 months of follow-up. For the post-approval study, success
was determined from the data collected up to 84 months.
Table 2: Schedule of Study Assessments
Evaluation Pre-op Surgery/ Hospital Discharge 6 wks
Preoperative Information
Obtain Screening Form X
Confirm Patient Eligibility X
Obtain Informed Consent X
Open Randomization Envelope X
Case Report Forms
Patient Enrollment X
Patient Qualification X
Preoperative Data X
Prior History Questionnaire X
Neurological Status X X X X X X X X X
Preoperative Gait Assessment and Foraminal Compression Test X
Preoperative Patient Survey X
Preoperative Neck Disability Index X
Preoperative Neck and Arm Pain Questionnaire X
Health Status Questionnaire (SF-36) X X X X X
Radiologic Data X X X X X X X X X X
Surgery Data X
Hospital Discharge X
Postoperative Data X X XXX
Postoperative Patient Survey X X XXXXXX
Neck Disability Index X X XXXXXX
Postoperative Neck and Arm Pain Questionnaire X X X X X X X X
Postoperative Gait Assessment and Foraminal Compression Test X X X X X X X X
Adverse Event Form (if any) X X X X X X X X X
Patient Accountability (if needed) X X X X X X X X
Outstanding (Unresolved) Adverse Event (if any) X X X X X X X X X
Imaging
Radiographs and Scans
Anterior/Posterior X-ray X X X X X X X X X X
Lateral X-ray X X X XXXXXXX
Right/Left Lateral Bend X-rays X X X X X X X X X
Flexion/Extension X-rays X X X X X X X X X
CT and/or MRI X
DEXA Scan X
IDE Study Post-approval Study
(± 2wks)
3 Mo
(± 2wks)
6 Mo
(± 1 Mo)
12 Mo
(± 2 Mo)
24 Mo
(± 2 Mo)
36 Mo
(± 3 Mo)
60 Mo
(± 3 Mo)
84 Mo
(± 3 Mo)
Data Source
New data collection
IDE and PAS Study Endpoints
The primary endpoint for both the IDE and post-approval studies was a composite variable termed “overall success” which
included key safety and effectiveness considerations. The effectiveness component of the overall success variable was
comprised of both Neck Disability Index (NDI) and disc height success as measured by Functional Spinal Unit (FSU) height.
The safety components of the overall success variable were neurological status success, absence of a serious implant- or
implant/surgical procedure-associated adverse event or a second surgery that is classified as a “failure”. The combined
effectiveness and safety component determined whether a patient was an overall success. An alternate overall success
determination was also evaluated without disc height success. Overall success was determined at the 24-month time point for
the IDE and the 84-month time point for the post-approval study.
Secondary endpoints for both the IDE and post-approval studies included neck pain, arm pain, general health status, patient
satisfaction, patient global perceived effect, and gait assessments.
Strengths and Limitations of the Clinical Study Design
The following are important study design strengths of the IDE study as well as the post-approval study:
▪ The PAS provided extended term profile of safety and effectiveness as well as functional data established on a multicenter,
randomized, controlled clinical trial.
▪ The consistency of data gathering approaches and endpoints was maintained through both the IDE and the PAS studies.
▪ The strength and reliability of the final IDE and PAS conclusions were confirmed by several sensitivity analyses.
▪ The study design minimized potential biases by integrating a wide variety of assessments including subjective data,
physician-judged and core laboratory-assessed evaluations.
The following potential study design limitations should also be considered when interpreting the results of the IDE study as well
as the post-approval study:
▪ Although overall success (without FSU) data was available for 89% of all subjects at 24 months, due to the long-term nature
of the IDE and the post-approval studies, progressive lower follow-up rates at each subsequent follow-up visit through 84
months were anticipated, which may affect interpretation of long-term study results.
▪ Several of the primary and secondary study endpoints are subjective (e.g., NDI, pain scores, SF-36), and this subjectivity
may present biases.
▪ Both the investigator and the patient were blinded to the randomized treatment throughout the screening and informed
consent process; however, the patient and surgeon were not blinded following the assignment of treatment group by the
sponsor. Like other clinical studies appraising artificial cervical disc devices, it was unfeasible to mask subjects to their
treatment assignment. This was well-adjusted by integrating result measures judged by both the surgeon and core
laboratories.
▪ The capability to evaluate device performance for individual segments of the subject population is limited. This limitation is
mainly because the study was not designed to assess performance among subgroups. Any subgroup analyses should be
evaluated with caution.
SUMMARY OF THE IDE AND POST-APPROVAL STUDY RESULTS
Subject Accountability
The subject accountability data for the patients enrolled IDE and post-approval studies covering 34 sites are summarized in
Table 3.
Table 3: Subject Accountability
IDE Study Post Approval Study
6 Mo
(± 1 Mo)
(86.2%)
(66.2%)
224
172
(± 2 Mo)
263
(95.6%)
204
(74.2%)
12 Mo
223
(87.1%)
172
(67.2%)
(± 2 Mo)
251
(91.3%)
189
(68.7%)
24 Mo
220
(86.6%)
169
(66.5%)
(± 3 Mo)
198
(72.0%)
150
(54.5%)
36 Mo
160
(63.2%)
124
(49.0%)
(± 3 Mo)
220
(81.8%)
167
(62.1%)
60 Mo
188
(76.1%)
138
(55.9%)
(± 3 Mo)
212
(78.8%)
168
(62.5%)
84 Mo
Variable Inv Ctrl Inv Ctrl Inv Ctrl Inv Ctrl Inv Ctrl Inv Ctrl Inv Ctrl
Total Enrolled Patients 276 265 276 265 276 265 276 265 276 265 276 265 276 265
Cumulative Withdrawn(s) After Surgery 0214171919513514
Cumulative Deaths 01010202032525
Theoretical Follow-up
Patients Evaluated Early
Patients Not Yet Over due
Expected
Evaluable for Overall Success without FSU (% of Total Expected) 254
Evaluable for Overall Success with FSU (% of Total Expected) 197
1
2
3
4
276 262 275 260 275 256 275 254 275 253 269 247 269 246
276 262 275 260 275 256 275 254 275 253 269 247 269 246
(92.0%)
(71.4%)
3 Mo
(± 2wks)
00000000000000
00000000000000
239
181
256
(93.1%)
196
(71.3%)
(91.2%)
(69.1%)
182
(74.0%)
135
(54.9%)
______________________________________________________________
1
Theoretical=Enrolled- Cumulative Deaths - Cumulative Withdrawn After Surgery
2
Patients that completed follow-up visits early in the visit window.
3
Number of patients who did not have evaluation on or before 08 Oct 2012 but were within the window.
4
Expected = Theoretical + Patients Evaluated Early for visit - Not Yet Overdue
Subject Demographics and Baseline Parameters
Table 4 summarizes the study patient demographics and baseline characteristics for the PRESTIGE™ Investigational and
control groups. The demographics of the study population are consistent with the demographics reported for prior cervical
artificial disc studies conducted in the U.S. The investigational and control treatment groups were very similar with regards to
the demographics and baseline parameters, and there were no statistical differences (p<0.05) for any of the variables in Table 4
with the exception of alcohol use
Table 4: Study Patient Demographics and Baseline Characteristics
Variables Inv
(N=276)
Age (years) 43.3 ± 7.6 43.9 ± 8.8 0.435
Height (inches) 67.4 ± 3.9 67.5 ± 4.2 0.767
Weight (lbs.) 181.7 ± 39.7 184.7 ± 41.5 0.389
Sex (% male) 128/276 (46.4%) 122/265 (46.0%) 1.000
Race
Caucasian
Black
Asian
Hispanic
Other
260/276 (94.2%)
6/276 (2.2%)
1/276 (0.4%)
7/276 (2.5%)
2/276 (0.7%)
Marital Status
Single
Married
Divorced
Separated
Widowed
44/276 (15.9%)
188/276 (68.1%)
36/276 (13.0%)
5/276 (1.8%)
3/276 (1.1%)
Ctrl
(N=265)
243/265 (91.7%)
13/265 (4.9%)
2/265 (0.8%)
6/265 (2.3%)
1/265 (0.4%)
32/265 (12.0%)
204/265 (77.0%)
24/265 (9.1%)
3/265 (1.1%)
2/265 (0.8%)
p-value
0.448
0.240
Table 4: Study Patient Demographics and Baseline Characteristics (continued)
Variables Inv
(N=276)
Education Level
< High School
High School
h School
> Hig
10/276 (3.6%)
73/276 (26.4%)
193/276 (69.9%)
Worker’s Compensation 32/276 (11.6%) 35/265 (13.2%) 0.603
Unresolved Spinal Litigation 30/276 (10.9%) 32/265 (12.1%) 0.687
Tobacco Used 95/276 (34.4%) 92/265 (34.7%) 1.000
Alcohol Used 120/276 (43.5%) 141/265 (53.2%) 0.025
Preoperative Work Status 182/276 (65.9%) 166/265 (62.6%) 0.473
Duration of Symptom
< 6 Weeks
6 Weeks to 6 Months
> 6
Months
21/276 (7.6%)
81/276 (29.3%)
174/276 (63.0%)
Previous Neck Surgery 1/276 (0.4%) 2/265 (0.8%) 0.617
Preoperative Medication use
Non-Narcotics
Weak Narcotics
Strong Narcotics
Muscle Relaxants
197/274 (71.9%)
130/275 (47.3%)
57/273 (20.9%)
119/274 (43.4%)
Preoperative Pain Status
Neither Arm or Neck Pain
Arm Pain Only
Neck Pain Only
Arm and Neck Pain
1/276 (0.4%)
1/276 (0.4%)
33/276 (12.0%)
241/276 (87.3%)
Baseline ROM Angulation 7.55 ± 4.25
Range: 0.43 - 24.85
Baseline ROM Translation 0.26 ± 0.26:
Range: 0.00 - 1.96
NDI 55.7 ± 14.8
Range: 6.0 – 94.0
SF-36 PCS 31.9 ± 7.0
Range: 15.3 – 51.7
SF-36 MCS 42.4 ± 12.1
Range: 16.3 – 65.3
Neck Pain Score 68.2 ± 22.7
Range: 2.0 – 100.0
Arm Pain Score 59.1 ± 29.4
Range: 0.0 – 100.0
Ctrl
(N=265)
14/265 (5.3%)
77/265 (29.2%)
173/265 (65.5%)
15/265 (5.7%)
89/265 (33.6%)
161/265 (60.8)
187/263 (71.1%)
127/263 (48.3%)
58/264 (22.0%)
114/264 (43.2%)
0/265 (0.0%)
0/265 (0.0%)
26/265 (9.8%)
238/265 (90.2%)
7.87 ± 4.32
Range: 0.74 – 21.34
0.26 ± 0.25
Range:0.00 – 1.64
56.4 ± 15.9
Range: 26.0 – 100.0
32.0 ± 7.5
Range: 7.9 – 56.0
42.7 ± 12.4
12.4
Range: 14.1 – 70.8
69.3 ± 21.5
Range: 20.0 – 100.0
62.4 ± 28.5
Rang
e: 0.0 – 100.0
p-value
0.458
0.435
0.849
0.863
0.833
1.000
0.491
0.446
0.989
0.632
0.760
0.795
0.553
0.191
Surgical and Hospitalization Information
Table 5 summarizes the information related to the surgical procedures and postoperative hospitalizations of subjects. The most
common treated surgical levels were C5-C6 and C6-C7. Table 6 summarizes device implanted by size and level. The mean
operative time; mean estimated blood loss volume; and the hospitalization times were similar in both groups.
Table 5: Surgical Results
Inv Ctrl p
Op
erative Time (hrs)
Mean ± SD 1.6 ± 0.6 1.4 ± 0.5 <0.001
EBL (ml)
Mean ± SD 60.1 ± 63.0 57.5 ± 68.1 0.635
Hospitalization (days)
Mean ± SD 1.1 ± 0.6 1.0 ± 0.5 0.041
Spinal level treated
C
(%) 7 (2.5) 10 (3.8)
3-4
C
(%) 14 (5.1) 15 (5.7)
4-5
- Value
0.041
Table 5: Surgical Results (continued)
Inv Ctrl p
C
(%) 142 (51.4) 149 (56.2)
5-6
C
(%) 113 (40.9) 91 (34.3)
6-7
- Value
Table 6: All PRESTIGE™ Devices Implanted by Size and Level
Treated Level
C3-C4 C4-C5 C5-C6 C6-C7 Total by Implant Size
Implant Size combinations
(Upper/Lower)
Upper: 6mm x 12mm
Lower: 6mm x 12mm
Upper: 7mm x 12mm
Lower: 7mm x 12mm
Upper: 7mm x 12mm
Lower: 7mm x 14mm
Upper: 7mm x 14mm
Lower: 7mm x 14mm
Upper: 8mm x 12mm
Lower: 8mm x 12mm
Upper: 8mm x 14mm
Lower: 8mm x 14mm
4 8 89 52 153/276 (55.4%)
0 3 23 16 42/276 (15.2%)
0 0 0 1 1/276 (0.4%)
2 2 20 30 54/276 (19.6%)
0 1 6 4 11/276 (4.0%)
1 0 4 10 15/276 (5.4%)
Total by Treated Level 7/276 (2.5%) 14/276 (5.1%) 142/276 (51.4%) 113/276 (40.9%) 276/276 (100.0%)
Safety Results
The safety of the PRESTIGE™ was assessed by monitoring intraoperative and postoperative complications. Radiographs were
examined for evidence of device migration or breakage. Observations of subsidence were reported by investigators as adverse
events. All radiographic endpoints were evaluated independently by a core laboratory.
Adverse Events
The adverse effects, as shown in Table 7 below, were reported from the 276 PRESTIGE™ device patients and 265 control
patients enrolled in the multi-center clinical study. Adverse event rates presented are based on the number of patients having at
least one occurrence for a particular adverse event divided by the total number of patients in that treatment group. Statistical
comparison of the adverse events was conducted using time to event analysis respectively for the cumulative event rate for any
adverse events up to 24-months visit and up to 84-months visit as shown in Table 8. The overall cumulative AE rate for events
up to 24-months visit (89.2% in the investigational group versus 90.2% in the control group, p-value form log-rank test = 0.692)
and up to 84-months visit (97.7% in the investigational group versus 94.5% in the control group, p-value form log-rank test =
0.958) are comparable between the two treatment groups. Additionally, Table 9 and 10, respectively summarize the adverse
events that are classified as device or device/surgical procedure related and the adverse events that are serious.
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