Trial Outcomes & Findings for Maverick Total Disc Replacement in a 'Real World' Patient Population (NCT NCT01338493)
NCT ID: NCT01338493
Last Updated: 2016-01-28
Results Overview
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 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.
Recruitment status
COMPLETED
Target enrollment
139 participants
Primary outcome timeframe
6 months
Results posted on
2016-01-28
Participant Flow
Participant milestones
| Measure |
Lumbar Spinal Arthroplasty + Maverick™
Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.
|
|---|---|
|
Enrolled
STARTED
|
139
|
|
Enrolled
COMPLETED
|
134
|
|
Enrolled
NOT COMPLETED
|
5
|
|
Implant
STARTED
|
134
|
|
Implant
COMPLETED
|
134
|
|
Implant
NOT COMPLETED
|
0
|
|
Discharge
STARTED
|
134
|
|
Discharge
COMPLETED
|
132
|
|
Discharge
NOT COMPLETED
|
2
|
|
6 Months Follow up
STARTED
|
132
|
|
6 Months Follow up
COMPLETED
|
113
|
|
6 Months Follow up
NOT COMPLETED
|
19
|
|
12 Months Follow up
STARTED
|
113
|
|
12 Months Follow up
COMPLETED
|
104
|
|
12 Months Follow up
NOT COMPLETED
|
9
|
|
24 Months Follow up
STARTED
|
104
|
|
24 Months Follow up
COMPLETED
|
104
|
|
24 Months Follow up
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Lumbar Spinal Arthroplasty + Maverick™
Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.
|
|---|---|
|
Enrolled
Withdrawal by Subject
|
1
|
|
Enrolled
Patient not implanted
|
4
|
|
Discharge
Death
|
1
|
|
Discharge
Missed visit
|
1
|
|
6 Months Follow up
Lost to Follow-up
|
11
|
|
6 Months Follow up
Missed visit
|
8
|
|
12 Months Follow up
Lost to Follow-up
|
9
|
Baseline Characteristics
Maverick Total Disc Replacement in a 'Real World' Patient Population
Baseline characteristics by cohort
| Measure |
Lumbar Spinal Arthroplasty + Maverick™
n=134 Participants
Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.
|
|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
79 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Reduction of disability was calculated for patients having available data at both baseline and 6 months.
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 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.
Outcome measures
| Measure |
Lumbar Spinal Arthroplasty + Maverick™
n=122 Participants
Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.
|
|---|---|
|
Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)
|
-25.4 units on a scale
Interval -29.0 to -21.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Reduction of disability was calculated for patients having available data at both baseline and 6 months.
Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced. 0 = no pain, 10 = worst possible pain
Outcome measures
| Measure |
Lumbar Spinal Arthroplasty + Maverick™
n=108 Participants
Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.
|
|---|---|
|
Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)
|
-4.0 units on a scale
Interval -4.5 to -3.4
|
Adverse Events
Lumbar Spinal Arthroplasty + Maverick™
Serious events: 57 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lumbar Spinal Arthroplasty + Maverick™
n=134 participants at risk
Patients requiring total disc replacement
lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.
|
|---|---|
|
General disorders
Abdominal wall related
|
6.7%
9/134 • Number of events 9 • 24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
|
|
Nervous system disorders
Neurologic - Access-related
|
9.0%
12/134 • Number of events 13 • 24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
|
|
Nervous system disorders
Neurologic - Late radiculopathy (not access-related)
|
9.0%
12/134 • Number of events 13 • 24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
|
|
Vascular disorders
Vascular
|
2.2%
3/134 • Number of events 3 • 24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
|
|
General disorders
Visceral - Bowel or Peritoneum
|
0.75%
1/134 • Number of events 1 • 24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
|
|
General disorders
Visceral - Genito-Urinary tract
|
3.7%
5/134 • Number of events 5 • 24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Subsidence / Impaction
|
0.75%
1/134 • Number of events 1 • 24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
|
|
General disorders
Early non-specific low BP
|
3.7%
5/134 • Number of events 5 • 24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
|
|
General disorders
Late non-specific low BP
|
4.5%
6/134 • Number of events 6 • 24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
|
|
Immune system disorders
Foreign body reaction
|
0.75%
1/134 • Number of events 1 • 24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
|
|
General disorders
Other events
|
17.9%
24/134 • Number of events 27 • 24 months
Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Confidential Information shall not be disclosed and shall be 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 90 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