18 and older, any sex, with Cervical Degenerative Disc Disease or Radiculopathy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Concentrations of Titanium, Vanadium, and Aluminum in the Blood SerumPrimary· 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.
Titanium at Preoperative
Group
Value
95% CI
PRESTIGE LP
0.2253
± 0.2264
Titanium at 6 weeks
Group
Value
95% CI
PRESTIGE LP
2.7268
± 1.4223
Titanium at 12 months
Group
Value
95% CI
PRESTIGE LP
4.8485
± 2.6315
Vanadium at Preoperative
Group
Value
95% CI
PRESTIGE LP
0.0522
± 0.1676
Vanadium at 6 weeks
Group
Value
95% CI
PRESTIGE LP
0.0508
± 0.0371
Vanadium at 12 months
Group
Value
95% CI
PRESTIGE LP
0.0538
± 0.0222
Aluminum at Preoperative
Group
Value
95% CI
PRESTIGE LP
1.1
± 1.1
Aluminum at 6 weeks
Group
Value
95% CI
PRESTIGE LP
1.3
± 1.6
Number of Participants Who Achieved Overall SuccessSecondary· 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".
3 months
Group
Value
95% CI
PRESTIGE LP
12
PRESTIGE LP
5
6 months
Group
Value
95% CI
PRESTIGE LP
11
PRESTIGE LP
5
12 months
Group
Value
95% CI
PRESTIGE LP
12
PRESTIGE LP
6
Number of Participants Who Achieved NDI SuccessSecondary· 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
3 Months
Group
Value
95% CI
PRESTIGE LP
13
PRESTIGE LP
5
6 Months
Group
Value
95% CI
PRESTIGE LP
12
PRESTIGE LP
5
12 Months
Group
Value
95% CI
PRESTIGE LP
14
PRESTIGE LP
5
Neck Pain and Arm PainSecondary· 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.
Neck Pain at Preoperative
Group
Value
95% CI
PRESTIGE LP
14.4
± 3.0
Neck Pain at 3 Months
Group
Value
95% CI
PRESTIGE LP
6.2
± 5.8
Neck Pain at 6 Months
Group
Value
95% CI
PRESTIGE LP
7.7
± 5.8
Neck Pain at 12 Months
Group
Value
95% CI
PRESTIGE LP
8.1
± 5.7
Arm Pain at Preoperative
Group
Value
95% CI
PRESTIGE LP
11.9
± 4.9
Arm Pain at 3 Months
Group
Value
95% CI
PRESTIGE LP
4.8
± 6.4
Arm Pain at 6 Months
Group
Value
95% CI
PRESTIGE LP
5.4
± 6.4
Arm Pain at 12 Months
Group
Value
95% CI
PRESTIGE LP
5.1
± 6.5
Number of Participants Who Achieved Neurological SuccessSecondary· 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.
3 Months
Group
Value
95% CI
PRESTIGE LP
16
PRESTIGE LP
1
6 Months
Group
Value
95% CI
PRESTIGE LP
14
PRESTIGE LP
0
12 Months
Group
Value
95% CI
PRESTIGE LP
15
PRESTIGE LP
3
Number of Participants Who Underwent Secondary Surgery at Index LevelSecondary· 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.
3 Months
Group
Value
95% CI
PRESTIGE LP
0
6 Months
Group
Value
95% CI
PRESTIGE LP
0
12 Months
Group
Value
95% CI
PRESTIGE LP
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medtronic Spinal and Biologics
Last refreshed: 5 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03062657.