Trial Outcomes & Findings for An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine (NCT NCT03062657)
NCT ID: NCT03062657
Last Updated: 2024-04-05
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Preoperative, 6 weeks, and 12 months
Results posted on
2024-04-05
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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25
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Overall Study
6 Week Follow-Up
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25
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Overall Study
3 Month Follow-Up
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18
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Overall Study
6 Month Follow-Up
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17
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine
Baseline characteristics by cohort
| Measure |
PRESTIGE LP
n=25 Participants
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.
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Age, Continuous
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52.2 years
STANDARD_DEVIATION 6.6 • n=93 Participants
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Sex: Female, Male
Female
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7 Participants
n=93 Participants
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Sex: Female, Male
Male
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18 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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21 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=93 Participants
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Region of Enrollment
United States
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25 participants
n=93 Participants
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Body Mass Index
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31.2 kg/m^2
STANDARD_DEVIATION 9.2 • n=93 Participants
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PRIMARY outcome
Timeframe: Preoperative, 6 weeks, and 12 monthsPopulation: Due to patient drop out not all patients attended every visit
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.
Outcome measures
| Measure |
PRESTIGE LP
n=24 Participants
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.
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Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
Titanium at Preoperative
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0.2253 ng/ml
Standard Deviation 0.2264
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Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
Titanium at 6 weeks
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2.7268 ng/ml
Standard Deviation 1.4223
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Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
Titanium at 12 months
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4.8485 ng/ml
Standard Deviation 2.6315
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Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
Vanadium at Preoperative
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0.0522 ng/ml
Standard Deviation 0.1676
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Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
Vanadium at 6 weeks
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0.0508 ng/ml
Standard Deviation 0.0371
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Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
Vanadium at 12 months
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0.0538 ng/ml
Standard Deviation 0.0222
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Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
Aluminum at Preoperative
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1.1 ng/ml
Standard Deviation 1.1
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Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
Aluminum at 6 weeks
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1.3 ng/ml
Standard Deviation 1.6
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Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
Aluminum at 12 months
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1.0 ng/ml
Standard Deviation 0.7
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SECONDARY outcome
Timeframe: 3, 6, and 12 monthsPopulation: 17 patients data are presented at 3 months 16 patients data are presented at 6 months 18 patients data are presented at 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".
Outcome measures
| Measure |
PRESTIGE LP
n=18 Participants
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.
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Number of Participants Who Achieved Overall Success
3 months · Overall Success Achieved
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12 Participants
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Number of Participants Who Achieved Overall Success
3 months · Overall Success Not Achieved
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5 Participants
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Number of Participants Who Achieved Overall Success
6 months · Overall Success Achieved
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11 Participants
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Number of Participants Who Achieved Overall Success
6 months · Overall Success Not Achieved
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5 Participants
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Number of Participants Who Achieved Overall Success
12 months · Overall Success Achieved
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12 Participants
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Number of Participants Who Achieved Overall Success
12 months · Overall Success Not Achieved
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6 Participants
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SECONDARY outcome
Timeframe: 3, 6, and 12 monthsPopulation: Due to drop out, not all patients were present for each visit.
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
Outcome measures
| Measure |
PRESTIGE LP
n=19 Participants
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.
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Number of Participants Who Achieved NDI Success
3 Months · NDI Success Achieved
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13 Participants
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Number of Participants Who Achieved NDI Success
3 Months · NDI Success Not Achieved
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5 Participants
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Number of Participants Who Achieved NDI Success
6 Months · NDI Success Achieved
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12 Participants
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Number of Participants Who Achieved NDI Success
6 Months · NDI Success Not Achieved
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5 Participants
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Number of Participants Who Achieved NDI Success
12 Months · NDI Success Achieved
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14 Participants
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Number of Participants Who Achieved NDI Success
12 Months · NDI Success Not Achieved
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5 Participants
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SECONDARY outcome
Timeframe: Preoperative, 3, 6, and 12 monthsPopulation: Due to drop out, not all patients were present for each visit.
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.
Outcome measures
| Measure |
PRESTIGE LP
n=25 Participants
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.
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Neck Pain and Arm Pain
Neck Pain at Preoperative
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14.4 Score on a scale
Standard Deviation 3.0
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Neck Pain and Arm Pain
Neck Pain at 3 Months
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6.2 Score on a scale
Standard Deviation 5.8
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Neck Pain and Arm Pain
Neck Pain at 6 Months
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7.7 Score on a scale
Standard Deviation 5.8
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Neck Pain and Arm Pain
Neck Pain at 12 Months
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8.1 Score on a scale
Standard Deviation 5.7
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Neck Pain and Arm Pain
Arm Pain at Preoperative
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11.9 Score on a scale
Standard Deviation 4.9
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Neck Pain and Arm Pain
Arm Pain at 3 Months
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4.8 Score on a scale
Standard Deviation 6.4
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Neck Pain and Arm Pain
Arm Pain at 6 Months
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5.4 Score on a scale
Standard Deviation 6.4
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Neck Pain and Arm Pain
Arm Pain at 12 Months
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5.1 Score on a scale
Standard Deviation 6.5
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SECONDARY outcome
Timeframe: 3, 6, and 12 monthsPopulation: Due to drop out, not all patients were present for each visit.
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.
Outcome measures
| Measure |
PRESTIGE LP
n=18 Participants
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.
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Number of Participants Who Achieved Neurological Success
3 Months · Overall Neurological Success Achieved
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16 Participants
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Number of Participants Who Achieved Neurological Success
3 Months · Overall Neurological Success Not Achieved
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1 Participants
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Number of Participants Who Achieved Neurological Success
6 Months · Overall Neurological Success Achieved
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14 Participants
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Number of Participants Who Achieved Neurological Success
6 Months · Overall Neurological Success Not Achieved
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0 Participants
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Number of Participants Who Achieved Neurological Success
12 Months · Overall Neurological Success Achieved
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15 Participants
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Number of Participants Who Achieved Neurological Success
12 Months · Overall Neurological Success Not Achieved
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3 Participants
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SECONDARY outcome
Timeframe: 3, 6, and 12 monthsPopulation: Due to participant drop-out/missed visits, the number of participants per timepoint varies.
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.
Outcome measures
| Measure |
PRESTIGE LP
n=25 Participants
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.
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Number of Participants Who Underwent Secondary Surgery at Index Level
3 Months
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0 Participants
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Number of Participants Who Underwent Secondary Surgery at Index Level
6 Months
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0 Participants
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Number of Participants Who Underwent Secondary Surgery at Index Level
12 Months
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0 Participants
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Adverse Events
PRESTIGE LP
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PRESTIGE LP
n=25 participants at risk
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.
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Musculoskeletal and connective tissue disorders
Arm Pain (Non-Cervical)
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4.0%
1/25 • Number of events 1 • Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.
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Nervous system disorders
Spinal Cord Disturbance
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4.0%
1/25 • Number of events 1 • Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.
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General disorders
Other Pain
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8.0%
2/25 • Number of events 2 • Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.
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Musculoskeletal and connective tissue disorders
Spinal Event (Cervical Non-Study Surgery)
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4.0%
1/25 • Number of events 1 • Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.
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Other adverse events
| Measure |
PRESTIGE LP
n=25 participants at risk
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.
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Gastrointestinal disorders
Dysphagia/Dysphonia (Grade 1/2)
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8.0%
2/25 • Number of events 3 • Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.
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Musculoskeletal and connective tissue disorders
Neck and/or Arm Pain (Grade 1/2)
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24.0%
6/25 • Number of events 9 • Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.
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Nervous system disorders
Neurological (Grade 1/2)
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28.0%
7/25 • Number of events 11 • Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.
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General disorders
Other Pain (Grade 1/2)
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20.0%
5/25 • Number of events 9 • Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.
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Injury, poisoning and procedural complications
Trauma (Grade 1/2)
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8.0%
2/25 • Number of events 2 • Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.
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Additional Information
Rhys Jones, PhD; Senior Clinical Research Specialist
Medtronic
Phone: +44 7826874430
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place