Trial Outcomes & Findings for PRESTIGE Observational Study (NCT NCT00875810)

NCT ID: NCT00875810

Last Updated: 2016-01-28

Results Overview

The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death.

• Recruitment status: COMPLETED
• Target enrollment: 194 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2016-01-28

Participant Flow

Participant milestones

Measure	Cervical Arthroplasty + Prestige LP All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
Overall Study STARTED	194
Overall Study Implanted	190
Overall Study Discharged	177
Overall Study 3 Months Follow up	175
Overall Study 6 Months Follow up	80
Overall Study 12 Months Follow up	112
Overall Study 24 Months Follow up	148
Overall Study COMPLETED	148
Overall Study NOT COMPLETED	46

Reasons for withdrawal

Measure	Cervical Arthroplasty + Prestige LP All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	3
Overall Study Lost to Follow-up	39
Overall Study Patient enroled but not implanted	2
Overall Study Device explanted	1

Baseline Characteristics

PRESTIGE Observational Study

Baseline characteristics by cohort

Measure	Cervical Arthroplasty + Prestige LP n=190 Participants All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
Age, Continuous	43.9 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Region of Enrollment Serbia	10 participants n=5 Participants
Region of Enrollment Saudi Arabia	11 participants n=5 Participants
Region of Enrollment Hungary	13 participants n=5 Participants
Region of Enrollment Czech Republic	44 participants n=5 Participants
Region of Enrollment Slovakia	28 participants n=5 Participants
Region of Enrollment Poland	83 participants n=5 Participants
Region of Enrollment Kuwait	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: As this is an observational study not all patients completed EQ-5D questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.

The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).

EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death.

Outcome measures

Measure	Cervical Arthroplasty + Prestige LP n=155 Participants All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
EQ-5D Baseline	0.59 units on a scale Standard Deviation 0.22
EQ-5D 3 months Follow up	0.78 units on a scale Standard Deviation 0.16
EQ-5D 6 months Follow up	0.77 units on a scale Standard Deviation 0.20
EQ-5D 12 months Follow up	0.80 units on a scale Standard Deviation 0.19
EQ-5D 24 months Follow up	0.76 units on a scale Standard Deviation 0.21

PRIMARY outcome

Timeframe: 2 years

Population: As this is an observational study not all patients completed NDI questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.

The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).

The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.

NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation.

Outcome measures

Measure	Cervical Arthroplasty + Prestige LP n=155 Participants All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
Neck Disability Index (NDI) Score Baseline	24.1 units on a scale Standard Deviation 8.6
Neck Disability Index (NDI) Score 3 months Follow up	13.2 units on a scale Standard Deviation 8.9
Neck Disability Index (NDI) Score 6 months Follow up	12.6 units on a scale Standard Deviation 10.2
Neck Disability Index (NDI) Score 12 months Follow up	12.3 units on a scale Standard Deviation 10.0
Neck Disability Index (NDI) Score 24 months	13.4 units on a scale Standard Deviation 10.3

SECONDARY outcome

Timeframe: Baseline visit

Documentation of duration of pain prior to enrollment

Outcome measures

Measure	Cervical Arthroplasty + Prestige LP n=190 Participants All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
Duration of Pain Prior to Enrollment patients with pain for 3-6 months before surgery	22.1 percentage of patients with pain
Duration of Pain Prior to Enrollment patients with pain for 6-12 months before surgery	21.3 percentage of patients with pain
Duration of Pain Prior to Enrollment patients with pain for >12 months before surgery	37.4 percentage of patients with pain

SECONDARY outcome

Timeframe: 2 years

Population: As this is an observational study not all patients had images available for each visit, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.

Outcome measures

Measure	Cervical Arthroplasty + Prestige LP n=96 Participants All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
Intervertebral Disc Space Baseline	0.22 millimiters Standard Deviation 0.07
Intervertebral Disc Space 3 months Follow up	0.41 millimiters Standard Deviation 0.15
Intervertebral Disc Space 6 months Follow up	0.42 millimiters Standard Deviation 0.16
Intervertebral Disc Space 12 months Follow up	0.40 millimiters Standard Deviation 0.14
Intervertebral Disc Space 24 months Follow up	0.39 millimiters Standard Deviation 0.13

Adverse Events

Cervical Arthroplasty + Prestige LP

Serious events: 7 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cervical Arthroplasty + Prestige LP n=190 participants at risk All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
Musculoskeletal and connective tissue disorders Lumbar pain	1.1% 2/190 • Number of events 3
Nervous system disorders syndroma carpi radialis	0.53% 1/190 • Number of events 1
Musculoskeletal and connective tissue disorders Arm pain	0.53% 1/190 • Number of events 1
Musculoskeletal and connective tissue disorders Quervain syndrome	0.53% 1/190 • Number of events 1
Nervous system disorders Thoracic spine discopathy	0.53% 1/190 • Number of events 1
General disorders Wound hematoma	0.53% 1/190 • Number of events 1

Other adverse events

Measure	Cervical Arthroplasty + Prestige LP n=190 participants at risk All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
General disorders Neck, shoulder and arm pain	12.6% 24/190 • Number of events 25
General disorders Lumbar pain	8.4% 16/190 • Number of events 18

Additional Information

Cristina Faria

MedtronicSpineECA

Phone: +41 21 802 70 00

Email: cristina.faria@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can review results communications prior to public release. The sponsor will limit its review to the determination of whether Confidential Information is disclosed and to check for technical correctness.
• Publication restrictions are in place

Restriction type: OTHER