Trial Outcomes & Findings for Satellite™ PEEK Nucleus Replacement Retrospective Analysis (NCT NCT01110967)

NCT ID: NCT01110967

Last Updated: 2016-01-28

Results Overview

The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.

• Recruitment status: COMPLETED
• Target enrollment: 40 participants
• Primary outcome timeframe: Up to 12 months follow up visit
• Results posted on: 2016-01-28

Participant Flow

Participant milestones

Measure	Patients Implanted With a Satellite Device
Overall Study STARTED	40
Overall Study Surgery	40
Overall Study 1 Month Follow up	26
Overall Study 3 Months Follow up	28
Overall Study 6 Months Follow up	24
Overall Study 12 Months Follow up	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Satellite™ PEEK Nucleus Replacement Retrospective Analysis

Baseline characteristics by cohort

Measure	Patients Implanted With a Satellite Device n=40 Participants
Age, Continuous	41 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment Czech Republic	2 participants n=5 Participants
Region of Enrollment Slovakia	8 participants n=5 Participants
Region of Enrollment Venezuela	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months follow up visit

The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.

Outcome measures

Measure	Patients Implanted With a Satellite Device n=32 Participants
Health-related Quality of Life Using the Visual Analogue Scale for Back Pain Back pain pre-operative (n = 32)	5.5 units on a scale Standard Deviation 2.7
Health-related Quality of Life Using the Visual Analogue Scale for Back Pain Back pain at 1 month Follow up (n = 25)	2.6 units on a scale Standard Deviation 2.2
Health-related Quality of Life Using the Visual Analogue Scale for Back Pain Back pain at 3 months Follow up (n = 25)	2.2 units on a scale Standard Deviation 2.3
Health-related Quality of Life Using the Visual Analogue Scale for Back Pain Back pain at 6 months Follow up (n = 18)	1.9 units on a scale Standard Deviation 1.8
Health-related Quality of Life Using the Visual Analogue Scale for Back Pain Back pain at 12 months Follow up (n = 26)	1.3 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Up to 12 months follow up visit

The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.

Outcome measures

Measure	Patients Implanted With a Satellite Device n=30 Participants
Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain Leg pain pre-operative (n = 30)	7.2 units on a scale Standard Deviation 2.0
Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain Leg pain at 1 month Follow up (n = 25)	1.8 units on a scale Standard Deviation 2.1
Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain Leg pain at 3 months Follow up (n = 25)	1.0 units on a scale Standard Deviation 1.3
Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain Leg pain at 6 months Follow up (n = 18)	0.3 units on a scale Standard Deviation 0.8
Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain Leg pain at 12 months Follow up (n = 26)	0.3 units on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: Up to 12 months follow up visit

The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 50; 0 meaning 'no disability' and 50 meaning 'maximum disability'.

Outcome measures

Measure	Patients Implanted With a Satellite Device n=38 Participants
Physical Functioning Using the Oswestry Disability Index (ODI) ODI pre-operative (n = 38)	48.2 units on a scale Standard Deviation 19.6
Physical Functioning Using the Oswestry Disability Index (ODI) ODI at 1 month Follow up (n = 26)	23.2 units on a scale Standard Deviation 16.0
Physical Functioning Using the Oswestry Disability Index (ODI) ODI at 3 months Follow up (n = 30)	18.6 units on a scale Standard Deviation 12.4
Physical Functioning Using the Oswestry Disability Index (ODI) ODI at 6 months Follow up (n = 23)	17.5 units on a scale Standard Deviation 13.0
Physical Functioning Using the Oswestry Disability Index (ODI) ODI at 12 months Follow up (n = 29)	11.4 units on a scale Standard Deviation 9.2

PRIMARY outcome

Timeframe: Patients were followed up according to the local practice, up to 1 year

Outcome measures

Measure	Patients Implanted With a Satellite Device n=40 Participants
Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)	7 events

SECONDARY outcome

Timeframe: Up to 12 months follow up visit

The range of motion (ROM) was calculated as the angle of the segment on the flexion radiograph minus the angle of the segment on the extension radiograph, expressed in degrees (absolute value).

Outcome measures

Measure	Patients Implanted With a Satellite Device n=22 Participants
Range of Motion (ROM) at Implanted Level ROM pre-operative (n = 22)	10.0 degrees Standard Deviation 7.9
Range of Motion (ROM) at Implanted Level ROM at 3 month Follow up (n = 20)	14.3 degrees Standard Deviation 5.8
Range of Motion (ROM) at Implanted Level ROM at 6 month Follow up (n = 16)	12.1 degrees Standard Deviation 9.8
Range of Motion (ROM) at Implanted Level ROM at 12 month Follow up (n = 16)	14.9 degrees Standard Deviation 6.1

SECONDARY outcome

Timeframe: Up to 12 months follow up visit

The Intervertebral Disc Space (IVD) was measured as average disc height, calculated as [(A+B)/2]/H, where A is the posterior intervertebral disc height, B is the anterior intervertebral disc height and H is the anterior height of upper vertebral body.

Outcome measures

Measure	Patients Implanted With a Satellite Device n=35 Participants
Intervertebral Disc Space (IVD) at Implanted Level IVD pre-operative (n = 35)	0.30 mm Standard Deviation 0.08
Intervertebral Disc Space (IVD) at Implanted Level IVD post-operative (n = 29)	0.29 mm Standard Deviation 0.07
Intervertebral Disc Space (IVD) at Implanted Level IVD at 3 months Follow up (n = 21)	0.28 mm Standard Deviation 0.07
Intervertebral Disc Space (IVD) at Implanted Level IVD at 6 months Follow up (n = 18)	0.26 mm Standard Deviation 0.06
Intervertebral Disc Space (IVD) at Implanted Level IVD at 12 months Follow up (n = 19)	0.26 mm Standard Deviation 0.06

SECONDARY outcome

Timeframe: Up to 12 months follow up visit

Interbody Height Ratio (IBHR) is calculated as the total vertical height of the two vertebral bodies directly superior and inferior to the implant divided by the anteroposterior diameter of the superior vertebral body.

Outcome measures

Measure	Patients Implanted With a Satellite Device n=34 Participants
Device Subsidence Measured as Interbody Height Ratio (IBHR) IBHR at surgery (n = 34)	1.9 ratio Standard Deviation 0.2
Device Subsidence Measured as Interbody Height Ratio (IBHR) IBHR at 3 months Follow up (n = 20)	1.9 ratio Standard Deviation 0.2
Device Subsidence Measured as Interbody Height Ratio (IBHR) IBHR at 6 months Follow up (n = 18)	1.7 ratio Standard Deviation 0.2
Device Subsidence Measured as Interbody Height Ratio (IBHR) IBHR at 12 months Follow up (n = 21)	2.0 ratio Standard Deviation 0.7

SECONDARY outcome

Timeframe: Up to 12 months follow up visit

Outcome measures

Measure	Patients Implanted With a Satellite Device n=35 Participants
Changes in Device Placement	1 participant

Adverse Events

Patients Implanted With a Satellite Device

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patients Implanted With a Satellite Device n=40 participants at risk
Musculoskeletal and connective tissue disorders Residual Radiculopathy	2.5% 1/40 • Number of events 1 • Patients were followed up according to the local practice, up to 1 year

Other adverse events

Measure	Patients Implanted With a Satellite Device n=40 participants at risk
Musculoskeletal and connective tissue disorders Residual Radiculopathy	2.5% 1/40 • Number of events 1 • Patients were followed up according to the local practice, up to 1 year
Musculoskeletal and connective tissue disorders Back pain and Sciatica	7.5% 3/40 • Number of events 3 • Patients were followed up according to the local practice, up to 1 year
Musculoskeletal and connective tissue disorders Low back pain	5.0% 2/40 • Number of events 2 • Patients were followed up according to the local practice, up to 1 year

Additional Information

Cristina Faria

Medtronic Spinal & Biologics

Phone: +41 (0)21 802 70 00

Email: cristina.faria@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee Confidential Information shall not be disclosed and shall be sole property of sponsor during the term of the agreement and for 3 years after agreement termination. Results might be published or presented, however sponsor should receive publication for review at least 7 days prior to submittal. Sponsor shall limit its review to a determination of whether Confidential Information is disclosed, to allow sponsor to protect its rights in copyrightable material, and to check for technical correctness.
• Publication restrictions are in place

Restriction type: OTHER