Introduction
Clinical material and methods
Trial description
Visit
|
1
|
2a
|
2b
|
2c
|
2d
|
2e
|
2f
|
3a
|
3b
|
3c–3j
|
3k
|
3l
|
4
|
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Events
|
Scree-ning
|
Baseline
|
SE
|
2 h p.s.
|
6 h p.s.
|
24 h p.s.
|
36 h p.s.
|
Examination
|
Implant
|
P.t.
|
48 h p.t.
|
21 d p.t.
|
Follow-up
|
Time windows
|
45 d p.sc.
|
2 h ± 30 min
|
6 h ± 30 min
|
24 h ± 2 h
|
36 ± 2 h
|
90 d ± 15 d
|
Directly + every 6 h ± 30 min
|
48 h ± 30 min
|
21 d ± 2d
|
42 d ± 7
| |||
Tests
|
Pre-operative
|
Intra-operative
|
2 h
|
6 h
|
24 h
|
36 h
|
Pre-implant
|
During implant
|
Post implant 6 h-intervals
|
48 h post implant
|
21 d post implant
|
Follow-up
| |
Informed Consent
|
x
| ||||||||||||
History
|
x
| ||||||||||||
Demography
|
x
| ||||||||||||
Medical and surgical history
|
x
| ||||||||||||
Vital signs, height, weight
|
x
|
x
|
x
| ||||||||||
Work status
|
x
|
x
|
x
|
x
|
x
| ||||||||
Tobacco use
|
x
|
x
|
x
|
x
| |||||||||
Review in-and exclusion criteria
|
x
|
x
|
x
| ||||||||||
MRI
|
x
|
x
|
x
|
x
|
x
|
x
| |||||||
Serological analysis
|
x
|
x
|
x
| ||||||||||
Blood pregnancy test
|
x
| ||||||||||||
Safety laboratory tests
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
| |||
Adverse event
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
| |
Concomitant medication
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Clinical investigation population
Assessments and laboratory values
Magnetic resonance imaging
Trial organization, registration, and ethical aspects
Investigational medicinal product
Sequestrectomy
Transplantation
Statistical analysis
Results
Characteristics
|
NDplus
n = 12
|
NDbasic
n = 12
| |
---|---|---|---|
Mean age in years (SD)
|
44.7 (6.7)
|
40.4 (9.8)
| |
Sex
|
Female
n
(%)
|
2/12 (16.6)
|
8/12 (66.6)
|
Male
n
(%)
|
10/12 (83.3)
|
4/12 (33.3)
| |
Tobacco use
|
No
n
(%)
|
7/12 (58.3)
|
8/12 (66.6)
|
Yes
n
(%)
|
5/12 (41.6)
|
4/12 (33.3)
| |
Work status
|
Working full-time
n
(%)
|
10/12 (83.3)
|
9/12 (75.0)
|
Working part-time
n
(%)
|
1/12 (8.3)
|
2/12 (16.6)
| |
Unemployed
n
(%)
|
1/12 (8.3)
|
0/12 (0.0)
| |
Not employed (e.g., homemaker, student)
n
(%)
|
0/12 (0.0)
|
1/12 (8.3)
| |
Retired
n
(%)
|
0/12 (0.0)
|
0/12 (0.0)
| |
BMI (kg/m2)
|
24.2 (2.2)
|
24.9 (2.8)
| |
Adjacent level degeneration
|
Presence of adjacent degenerative disc
n
(%)
|
2/12 (16.6)
|
5/12 (41.6)
|
Absence of adjacent degenerative disc
n
(%)
|
10/12 (83.3)
|
7/12 (58.3)
| |
Location of disc herniation
|
Between vertebra L3 and L4
n
(%)
|
1/12 (8.3)
|
0/12 (0.0)
|
Between vertebra L4 and L5
n
(%)
|
3/12 (25.0)
|
3/12 (25.0)
| |
Between vertebra L5 and S1
n
(%)
|
8/12 (66.6)
|
9/12 (75.0)
| |
Prior analgesic medication
|
Subjects with prior analgesic medication
|
10/12 (83 %)
|
11/12 (91.7)
|
Opioids, metamizole, paracetamol
|
5/12 (41.6)
|
6/12 (50)
| |
Non-steroidal anti-inflammatory drugs (e.g., diclofenac, naproxen)
|
6/12 (50.0)
|
11/12 (91.7)
|