Cervical Degenerative Disc Disease, Myelopathy, Radiculopathy
Conditions
Brief summary
This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. The information obtained from this clinical investigation will be used to support the post market surveillance for a PMA supplement for the PRESTIGE LP™ Cervical Disc implanted at two contiguous levels.
Interventions
DEVICEPRESTIGE LP™ Cervical Disc
The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels.
Sponsors
Medtronic Spinal and Biologics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A patient must meet all of the following inclusion criteria to participate in this study: 1. Has cervical degenerative disc disease at two (2) contiguous cervical levels (from C3 to C7) requiring surgical treatment and involving intractable radiculopathy, myelopathy or both; 2. Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history (e.g., neck and/or arm pain, functional deficit and /or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.); 3. Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative therapy; 4. Has no previous surgical intervention at the involved levels or any other planned/staged surgical procedure at the involved levels; 5. Has preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire; 6. Must be at least 18 years of age and be skeletally mature at the time of surgery; 7. If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period; 8. Is willing to comply with the study plan and sign the Patient Informed Consent Form.
Exclusion criteria
A patient will be excluded from participating in this study for any of the following reasons: 1. Has a cervical spine condition other than symptomatic cervical degenerative disease requiring surgical treatment at the involved levels; 2. Has documented or diagnosed cervical instability relative to contiguous segments at either level, defined by dynamic (flexion/extension) radiographs showing: 1. Sagittal plane translation \> 3.5 mm, or 2. Sagittal plane angulation \> 20° 3. Has more than two cervical levels requiring surgical treatment; 4. Has severe pathology of the facet joints of the involved vertebral bodies; 5. Has had previous surgical intervention at either one or both of the involved levels; 6. Has been previously diagnosed with osteopenia or osteomalacia; 7. Has any of the following that may be associated with a diagnosis of osteoporosis (If Yes to any of the below risk factors, a DEXA Scan will be required to determine eligibility.): 1. . Postmenopausal non-Black female over 60 years of age who weighs less than 140 pounds. 2. Postmenopausal female who has sustained a non-traumatic hip, spine or wrist fracture. 3. Male over the age of 70. 4. Male over the age of 60 who has sustained a non-traumatic hip or spine fracture. If the level of BMD is a T score of -3.5 or lower (i.e., -3.6, -3.7, etc.) or a T score of -2.5 or lower (i.e., -2.6, -2.7 etc.) with vertebral crush fracture, then the patient is excluded from the study 8. Has presence of spinal metastases; 9. Has overt or active bacterial infection, either local or systemic; 10. Has chronic or acute renal failure or prior history of renal disease; 11. Has a documented allergy or intolerance to titanium, or a titanium alloy; 12. Is mentally incompetent. (If questionable, obtain psychiatric consult); 13. Is a prisoner; 14. Is pregnant; 15. Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs; 16. Has history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta); 17. Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs.); 18. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation. 19. Is currently taking or has had chronic usage of certain prescription medications (e.g., Cloxacillin, an antibiotic used for prophylaxis against surgical infections, and/or Clotrimazole).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | Preoperative, 6 weeks, and 12 months | The concentrations of Titanium, Vanadium, and Aluminum at different time points will be summarized using mean and standard deviation. One participant did not receive metal concentration analysis at baseline, therefore the baseline number of participants for these measures N = 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Overall Success | 3, 6, and 12 months | The patients enrolled in the study who receive the PRESTIGE LP™ Cervical Disc at two contiguous levels will be considered an overall success if the following criteria are met: 1. NDI score improvement of at least 15 points from baseline; 2. Maintenance or improvement in neurological status; 3. No serious AE classified as implant associated/related or implant/surgical procedure associated/related; 4. No secondary surgical procedure classified as a failure. |
| Number of Participants Who Achieved NDI Success | 3, 6, and 12 months | The self-administered Neck Disability Index (NDI) Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score \> 15 |
| Neck Pain and Arm Pain | Preoperative, 3, 6, and 12 months | Numerical rating scales adapted in part from Measuring Health (McDowell and Newell, 1996) will be used to evaluate neck pain and arm pain. Intensity of pain is ranked from 0-10 with 0 being no pain and 10 being pain as bad as it could be; duration of pain is ranked from 0-10 with 0 being none of the time and 10 being pain all of the time. The pain score is derived by adding the numerical rating scores from the pain intensity and duration scales. Therefore the total pain is ranked between 0-20 with 0 being no pain, none of the time; and 20 being maximum pain, constantly. |
| Number of Participants Who Achieved Neurological Success | 3, 6, and 12 months | Neurological status is based on motor function, sensory function, and reflexes. Each of the categories is comprised of a number of elements. Postoperative evaluations of each element will be compared to the preoperative evaluations. Success will be defined as maintenance or improvement in each element for the time period evaluated. |
| Number of Participants Who Underwent Secondary Surgery at Index Level | 3, 6, and 12 months | Some AEs or treatment failures may lead to a secondary surgical intervention at an operated index level. All patients undergoing a secondary surgical intervention at any operated index level will be followed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PRESTIGE LP Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7.
PRESTIGE LP™ Cervical Disc: The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | PRESTIGE LP |
|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 6.6 |
| Body Mass Index | 31.2 kg/m^2 STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 14 / 25 |
| serious Total, serious adverse events | 4 / 25 |
Outcome results
Primary
Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
The concentrations of Titanium, Vanadium, and Aluminum at different time points will be summarized using mean and standard deviation. One participant did not receive metal concentration analysis at baseline, therefore the baseline number of participants for these measures N = 24.
Time frame: Preoperative, 6 weeks, and 12 months
Population: Due to patient drop out not all patients attended every visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRESTIGE LP | Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | Titanium at Preoperative | 0.2253 ng/ml | Standard Deviation 0.2264 |
| PRESTIGE LP | Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | Titanium at 6 weeks | 2.7268 ng/ml | Standard Deviation 1.4223 |
| PRESTIGE LP | Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | Titanium at 12 months | 4.8485 ng/ml | Standard Deviation 2.6315 |
| PRESTIGE LP | Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | Vanadium at Preoperative | 0.0522 ng/ml | Standard Deviation 0.1676 |
| PRESTIGE LP | Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | Vanadium at 6 weeks | 0.0508 ng/ml | Standard Deviation 0.0371 |
| PRESTIGE LP | Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | Vanadium at 12 months | 0.0538 ng/ml | Standard Deviation 0.0222 |
| PRESTIGE LP | Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | Aluminum at Preoperative | 1.1 ng/ml | Standard Deviation 1.1 |
| PRESTIGE LP | Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | Aluminum at 6 weeks | 1.3 ng/ml | Standard Deviation 1.6 |
| PRESTIGE LP | Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | Aluminum at 12 months | 1.0 ng/ml | Standard Deviation 0.7 |
Secondary
Neck Pain and Arm Pain
Numerical rating scales adapted in part from Measuring Health (McDowell and Newell, 1996) will be used to evaluate neck pain and arm pain. Intensity of pain is ranked from 0-10 with 0 being no pain and 10 being pain as bad as it could be; duration of pain is ranked from 0-10 with 0 being none of the time and 10 being pain all of the time. The pain score is derived by adding the numerical rating scores from the pain intensity and duration scales. Therefore the total pain is ranked between 0-20 with 0 being no pain, none of the time; and 20 being maximum pain, constantly.
Time frame: Preoperative, 3, 6, and 12 months
Population: Due to drop out, not all patients were present for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRESTIGE LP | Neck Pain and Arm Pain | Neck Pain at Preoperative | 14.4 Score on a scale | Standard Deviation 3 |
| PRESTIGE LP | Neck Pain and Arm Pain | Neck Pain at 3 Months | 6.2 Score on a scale | Standard Deviation 5.8 |
| PRESTIGE LP | Neck Pain and Arm Pain | Neck Pain at 6 Months | 7.7 Score on a scale | Standard Deviation 5.8 |
| PRESTIGE LP | Neck Pain and Arm Pain | Neck Pain at 12 Months | 8.1 Score on a scale | Standard Deviation 5.7 |
| PRESTIGE LP | Neck Pain and Arm Pain | Arm Pain at Preoperative | 11.9 Score on a scale | Standard Deviation 4.9 |
| PRESTIGE LP | Neck Pain and Arm Pain | Arm Pain at 3 Months | 4.8 Score on a scale | Standard Deviation 6.4 |
| PRESTIGE LP | Neck Pain and Arm Pain | Arm Pain at 6 Months | 5.4 Score on a scale | Standard Deviation 6.4 |
| PRESTIGE LP | Neck Pain and Arm Pain | Arm Pain at 12 Months | 5.1 Score on a scale | Standard Deviation 6.5 |
Secondary
Number of Participants Who Achieved NDI Success
The self-administered Neck Disability Index (NDI) Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score \> 15
Time frame: 3, 6, and 12 months
Population: Due to drop out, not all patients were present for each visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRESTIGE LP | Number of Participants Who Achieved NDI Success | 3 Months | NDI Success Achieved | 13 Participants |
| PRESTIGE LP | Number of Participants Who Achieved NDI Success | 3 Months | NDI Success Not Achieved | 5 Participants |
| PRESTIGE LP | Number of Participants Who Achieved NDI Success | 6 Months | NDI Success Achieved | 12 Participants |
| PRESTIGE LP | Number of Participants Who Achieved NDI Success | 6 Months | NDI Success Not Achieved | 5 Participants |
| PRESTIGE LP | Number of Participants Who Achieved NDI Success | 12 Months | NDI Success Achieved | 14 Participants |
| PRESTIGE LP | Number of Participants Who Achieved NDI Success | 12 Months | NDI Success Not Achieved | 5 Participants |
Secondary
Number of Participants Who Achieved Neurological Success
Neurological status is based on motor function, sensory function, and reflexes. Each of the categories is comprised of a number of elements. Postoperative evaluations of each element will be compared to the preoperative evaluations. Success will be defined as maintenance or improvement in each element for the time period evaluated.
Time frame: 3, 6, and 12 months
Population: Due to drop out, not all patients were present for each visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRESTIGE LP | Number of Participants Who Achieved Neurological Success | 3 Months | Overall Neurological Success Achieved | 16 Participants |
| PRESTIGE LP | Number of Participants Who Achieved Neurological Success | 3 Months | Overall Neurological Success Not Achieved | 1 Participants |
| PRESTIGE LP | Number of Participants Who Achieved Neurological Success | 6 Months | Overall Neurological Success Achieved | 14 Participants |
| PRESTIGE LP | Number of Participants Who Achieved Neurological Success | 6 Months | Overall Neurological Success Not Achieved | 0 Participants |
| PRESTIGE LP | Number of Participants Who Achieved Neurological Success | 12 Months | Overall Neurological Success Achieved | 15 Participants |
| PRESTIGE LP | Number of Participants Who Achieved Neurological Success | 12 Months | Overall Neurological Success Not Achieved | 3 Participants |
Secondary
Number of Participants Who Achieved Overall Success
The patients enrolled in the study who receive the PRESTIGE LP™ Cervical Disc at two contiguous levels will be considered an overall success if the following criteria are met: 1. NDI score improvement of at least 15 points from baseline; 2. Maintenance or improvement in neurological status; 3. No serious AE classified as implant associated/related or implant/surgical procedure associated/related; 4. No secondary surgical procedure classified as a failure.
Time frame: 3, 6, and 12 months
Population: 17 patients data are presented at 3 months 16 patients data are presented at 6 months 18 patients data are presented at 12 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRESTIGE LP | Number of Participants Who Achieved Overall Success | 3 months | Overall Success Achieved | 12 Participants |
| PRESTIGE LP | Number of Participants Who Achieved Overall Success | 3 months | Overall Success Not Achieved | 5 Participants |
| PRESTIGE LP | Number of Participants Who Achieved Overall Success | 6 months | Overall Success Achieved | 11 Participants |
| PRESTIGE LP | Number of Participants Who Achieved Overall Success | 6 months | Overall Success Not Achieved | 5 Participants |
| PRESTIGE LP | Number of Participants Who Achieved Overall Success | 12 months | Overall Success Achieved | 12 Participants |
| PRESTIGE LP | Number of Participants Who Achieved Overall Success | 12 months | Overall Success Not Achieved | 6 Participants |
Secondary
Number of Participants Who Underwent Secondary Surgery at Index Level
Some AEs or treatment failures may lead to a secondary surgical intervention at an operated index level. All patients undergoing a secondary surgical intervention at any operated index level will be followed.
Time frame: 3, 6, and 12 months
Population: Due to participant drop-out/missed visits, the number of participants per timepoint varies.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRESTIGE LP | Number of Participants Who Underwent Secondary Surgery at Index Level | 3 Months | 0 Participants |
| PRESTIGE LP | Number of Participants Who Underwent Secondary Surgery at Index Level | 6 Months | 0 Participants |
| PRESTIGE LP | Number of Participants Who Underwent Secondary Surgery at Index Level | 12 Months | 0 Participants |