Trial Outcomes & Findings for Fenestrated Screw Study (NCT NCT03797144)
NCT ID: NCT03797144
Last Updated: 2021-08-24
Results Overview
Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point.
TERMINATED
NA
27 participants
Baseline to 12 months
2021-08-24
Participant Flow
The study aimed at evaluating overall 100 subjects with around 50 subjects (no less than 48 subjects) in each indication subgroup at approximately 10 study sites in Europe. Due to the premature closure of the study, the number of enrolled subjects was 27 (16 belonging to the degenerative spinal disease group and 11 to the deformity group) in 6 sites in Europe.
Participant milestones
| Measure |
Degenerative Spinal Disease
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Enrollment
STARTED
|
16
|
11
|
|
Enrollment
COMPLETED
|
12
|
10
|
|
Enrollment
NOT COMPLETED
|
4
|
1
|
|
Surgery
STARTED
|
12
|
10
|
|
Surgery
COMPLETED
|
11
|
10
|
|
Surgery
NOT COMPLETED
|
1
|
0
|
|
3 Month
STARTED
|
11
|
10
|
|
3 Month
COMPLETED
|
9
|
10
|
|
3 Month
NOT COMPLETED
|
2
|
0
|
|
12 Month
STARTED
|
9
|
10
|
|
12 Month
COMPLETED
|
1
|
1
|
|
12 Month
NOT COMPLETED
|
8
|
9
|
|
24 Month
STARTED
|
1
|
1
|
|
24 Month
COMPLETED
|
0
|
0
|
|
24 Month
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Degenerative Spinal Disease
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Enrollment
Protocol Violation
|
4
|
1
|
|
Surgery
Protocol Violation
|
1
|
0
|
|
3 Month
Early termination cut-off date
|
2
|
0
|
|
12 Month
Early termination cut-off date
|
8
|
9
|
|
24 Month
Early termination cut-off date
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Degenerative Spinal Disease
n=11 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=10 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 10 • n=11 Participants
|
70.9 years
STANDARD_DEVIATION 6.6 • n=10 Participants
|
70.7 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
60.8 Kg
STANDARD_DEVIATION 13.3 • n=11 Participants
|
66.6 Kg
STANDARD_DEVIATION 10.8 • n=10 Participants
|
63.5 Kg
STANDARD_DEVIATION 12.2 • n=21 Participants
|
|
Height
|
159.3 cm
STANDARD_DEVIATION 7.3 • n=11 Participants
|
158.6 cm
STANDARD_DEVIATION 8.2 • n=10 Participants
|
159.0 cm
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Body Max Index (BMI)
|
23.9 kg/m^2
STANDARD_DEVIATION 4.1 • n=11 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 3.6 • n=10 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 4.0 • n=21 Participants
|
|
Duration of conservative treatment
|
21.6 months
STANDARD_DEVIATION 49.0 • n=11 Participants
|
20.9 months
STANDARD_DEVIATION 22.7 • n=10 Participants
|
21.3 months
STANDARD_DEVIATION 37.8 • n=21 Participants
|
|
Duration of Back Pain Resulting in Planned Surgery
|
13.5 months
STANDARD_DEVIATION 13.6 • n=11 Participants
|
17.5 months
STANDARD_DEVIATION 17.9 • n=10 Participants
|
15.4 months
STANDARD_DEVIATION 15.5 • n=21 Participants
|
|
Duration of Leg Pain Resulting in Planned Surgery
|
11.0 months
STANDARD_DEVIATION 11.4 • n=11 Participants
|
9.2 months
STANDARD_DEVIATION 6.1 • n=10 Participants
|
10.1 months
STANDARD_DEVIATION 9.1 • n=21 Participants
|
|
Duration of Other Generalized Pain Resulting in Planned Surgery
|
0.0 months
STANDARD_DEVIATION 0.0 • n=11 Participants
|
12.0 months
STANDARD_DEVIATION 37.9 • n=10 Participants
|
5.7 months
STANDARD_DEVIATION 26.2 • n=21 Participants
|
|
Patients with previous surgeries
|
4 participants
n=11 Participants
|
2 participants
n=10 Participants
|
6 participants
n=21 Participants
|
|
Bone Density Assessment
|
-1.9 T-score
STANDARD_DEVIATION 0.8 • n=8 Participants • For 3 subjects the Bone Density Assessment was missing, and compromised bone quality was confirmed during surgery.
|
-1.9 T-score
STANDARD_DEVIATION 0.8 • n=10 Participants • For 3 subjects the Bone Density Assessment was missing, and compromised bone quality was confirmed during surgery.
|
-1.9 T-score
STANDARD_DEVIATION 0.7 • n=18 Participants • For 3 subjects the Bone Density Assessment was missing, and compromised bone quality was confirmed during surgery.
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Due to the premature termination of the study, the number of subjects who completed the 12 month follow-up visit was very low (N=2/21, 9.5%).
Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point.
Outcome measures
| Measure |
Degenerative Spinal Disease
n=1 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=1 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline
|
46.0 score on a scale
|
17.8 score on a scale
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point.
Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. \[23\]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point.
Outcome measures
| Measure |
Degenerative Spinal Disease
n=11 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=10 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Change in ODI From Baseline at 3 Months Visit
Baseline
|
49.7 score on a scale
Standard Deviation 20.0
|
39.6 score on a scale
Standard Deviation 13.0
|
|
Change in ODI From Baseline at 3 Months Visit
3 Month
|
20.9 score on a scale
Standard Deviation 24.9
|
23.0 score on a scale
Standard Deviation 21.7
|
|
Change in ODI From Baseline at 3 Months Visit
Change from Baseline
|
31.5 score on a scale
Standard Deviation 28.9
|
16.6 score on a scale
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: Baseline, 3, 12 monthsPopulation: The results are summarized for 21 subjects who were assessed at Baseline,19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported.
Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible. The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point. The 24 months follow-up visit did not have data collected and are not reported.
Outcome measures
| Measure |
Degenerative Spinal Disease
n=11 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=10 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Leg Pain_3 Months
|
0.9 score on a scale
Standard Deviation 1.3
|
1.3 score on a scale
Standard Deviation 1.8
|
|
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Leg Pain_Change from Baseline at 3 Months
|
6.2 score on a scale
Standard Deviation 2.7
|
5.8 score on a scale
Standard Deviation 2.5
|
|
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Leg Pain_12 Months
|
0.0 score on a scale
Standard Deviation 0.0
|
1.0 score on a scale
Standard Deviation 0.0
|
|
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Leg Pain_Change form Baseline at 12 Months
|
6.0 score on a scale
Standard Deviation 0.0
|
1.0 score on a scale
Standard Deviation 0.0
|
|
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Back Pain_Baseline
|
4.9 score on a scale
Standard Deviation 2.9
|
6.8 score on a scale
Standard Deviation 2.3
|
|
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Back Pain_3 Months
|
2.0 score on a scale
Standard Deviation 2.8
|
1.7 score on a scale
Standard Deviation 1.8
|
|
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Back Pain_Change from Baseline at 3 Months
|
3.3 score on a scale
Standard Deviation 2.6
|
5.1 score on a scale
Standard Deviation 3.2
|
|
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Back Pain_12 Months
|
2.0 score on a scale
Standard Deviation 0.0
|
3.0 score on a scale
Standard Deviation 0.0
|
|
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Back Pain_Change from Baseline at 12 Months
|
3.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
|
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Leg Pain_Baseline
|
7.5 score on a scale
Standard Deviation 2.2
|
7.1 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline, 3, 12 monthsPopulation: The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.
The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems). EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported.
Outcome measures
| Measure |
Degenerative Spinal Disease
n=11 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=10 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
Index score_Baseline
|
0.24 score on a scale
Standard Deviation 0.25
|
0.39 score on a scale
Standard Deviation 0.19
|
|
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
Index score_3 Months
|
0.66 score on a scale
Standard Deviation 0.37
|
0.68 score on a scale
Standard Deviation 0.34
|
|
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
Index score_Change from Baseline at 3 Months
|
0.43 score on a scale
Standard Deviation 0.36
|
0.28 score on a scale
Standard Deviation 0.33
|
|
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
Index score_12 Months
|
0.910 score on a scale
Standard Deviation 0.0
|
0.910 score on a scale
Standard Deviation 0.0
|
|
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
Index score_Change from Baseline at 12 Months
|
0.423 score on a scale
Standard Deviation 0.0
|
0.423 score on a scale
Standard Deviation 0.0
|
|
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
Health State score_Baseline
|
64.8 score on a scale
Standard Deviation 20.3
|
57.5 score on a scale
Standard Deviation 15.9
|
|
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
Health State score_3 Months
|
72.8 score on a scale
Standard Deviation 21.7
|
82.2 score on a scale
Standard Deviation 16.5
|
|
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
Health State score_Change from Baseline
|
11.9 score on a scale
Standard Deviation 35.8
|
24.7 score on a scale
Standard Deviation 20.3
|
|
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
Health State score_12 Months
|
90.0 score on a scale
Standard Deviation 0.0
|
70.0 score on a scale
Standard Deviation 0.0
|
|
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
Health State score_Change from Baseline at 12 Months
|
50.0 score on a scale
Standard Deviation 0.0
|
20.0 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline to 12 months.Population: 21 subjects were assessed at Baseline,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Due to the premature termination of the study, the number of subjects who completed the 12 months follow-up visit was very low (N=2/21, 9.5%).
Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced). Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve).
Outcome measures
| Measure |
Degenerative Spinal Disease
n=1 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=1 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Rate of Neurological Success at 12-month Visit
Motor Functions_Baseline
|
5 score on a scale
|
5 score on a scale
|
|
Rate of Neurological Success at 12-month Visit
Motor Functions_12 Months
|
5 score on a scale
|
5 score on a scale
|
|
Rate of Neurological Success at 12-month Visit
Sensory Functions_Baseline
|
3 score on a scale
|
3 score on a scale
|
|
Rate of Neurological Success at 12-month Visit
Sensory Functions_12 Months
|
3 score on a scale
|
3 score on a scale
|
|
Rate of Neurological Success at 12-month Visit
Reflexes_Baseline
|
2 score on a scale
|
2 score on a scale
|
|
Rate of Neurological Success at 12-month Visit
Reflexes_12 Months
|
2 score on a scale
|
2 score on a scale
|
|
Rate of Neurological Success at 12-month Visit
Straight Leg Raise_Baseline
|
2 score on a scale
|
2 score on a scale
|
|
Rate of Neurological Success at 12-month Visit
Straight Leg Raise_12 Months
|
2 score on a scale
|
2 score on a scale
|
SECONDARY outcome
Timeframe: Surgery to 12 months.Population: 21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit.
The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.
Outcome measures
| Measure |
Degenerative Spinal Disease
n=11 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=10 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Rate of Intraoperative Cement Extravasation/Leakage. Patients
Patients with cement extravasation
|
3 participants
|
5 participants
|
|
Rate of Intraoperative Cement Extravasation/Leakage. Patients
Patients with symptomatic extravasation
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Surgery to 12 months.Population: 21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit.
The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.
Outcome measures
| Measure |
Degenerative Spinal Disease
n=11 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=10 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Rate of Intraoperative Cement Extravasation/Leakage. Screws
Fenestrated Screws with cement extravasation
|
3 Screws
|
8 Screws
|
|
Rate of Intraoperative Cement Extravasation/Leakage. Screws
Number of Cemented Fenestrated Screws
|
39 Screws
|
97 Screws
|
|
Rate of Intraoperative Cement Extravasation/Leakage. Screws
Fenestrated screws with symptomatic cement extravasation
|
0 Screws
|
0 Screws
|
SECONDARY outcome
Timeframe: Surgery to 12 months.Population: 21 subjects were assessed at surgery,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Adverse events up to 12 month follow-up visits are reported in the Outcome Measure Data Table.
The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship. For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.
Outcome measures
| Measure |
Degenerative Spinal Disease
n=11 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=10 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
Serious Adverse Event (SAE)
|
1 Events
|
6 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
Serious Adverse Device Effect (SADE)
|
1 Events
|
5 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
Unexpected Serious Adverse Device Effect (USADE)
|
0 Events
|
0 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to Procedure
|
0 Events
|
5 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to Access System
|
0 Events
|
0 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to Anterior Plate
|
0 Events
|
0 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
Not Related SAEs_Investigator assessment
|
0 Events
|
0 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
Adverse Event (AE)
|
2 Events
|
8 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to Cage/Interbody
|
0 Events
|
0 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to Bone Grafts and Substitutes
|
0 Events
|
1 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to Rods
|
0 Events
|
1 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to Fenestrated Screw Cement_Investigator assessment
|
0 Events
|
0 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to Fenestrated Screw Cement_Sponsor assessment
|
0 Events
|
1 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to Fenestrated Screw(s)
|
0 Events
|
0 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to other components of the Fixation (stabilization) System
|
1 Events
|
0 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to an underlying condition or disease_Investigator assessment
|
0 Events
|
2 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
SAEs Related to an underlying condition or disease_Sponsor assessment
|
1 Events
|
1 Events
|
|
Device and/or Procedure Related Adverse Events Through 12 Months.
Not Related SAEs_Sponsor assessment
|
0 Events
|
1 Events
|
SECONDARY outcome
Timeframe: Surgery to 12 months.Population: 21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.
When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery. Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other. One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1.
Outcome measures
| Measure |
Degenerative Spinal Disease
n=11 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=10 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Surgery to 12 months.Population: 2 subjects completed the 12 month follow-up visit.
The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months. The following were considered as signs of instrumentation instability: * Screw pullout * Screw loosening * Screw toggle
Outcome measures
| Measure |
Degenerative Spinal Disease
n=1 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=1 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit.
Stable Construct
|
1 Participants
|
1 Participants
|
|
Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit.
Unstable Construct
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Surgery to 12 months.Population: 2 subjects who completed the 12 month follow-up visit were analyzed for fusion assessment with radiographic images.
The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays. The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (\<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine.
Outcome measures
| Measure |
Degenerative Spinal Disease
n=1 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=1 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended.
Fusion success
|
0 Participants
|
0 Participants
|
|
Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended.
No fusion success
|
0 Participants
|
0 Participants
|
|
Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended.
Unable to determine
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 1 subject who completed the 12 month follow-up visit was analyzed.
Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: * Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). * Sagittal spinopelvic parameters: Pelvic Incidence (PI): Pelvic Tilt (PT) and Sacral Slope (SS)
Outcome measures
| Measure |
Degenerative Spinal Disease
n=1 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
Baseline Thoracic Kyphosis (TK) (degrees)
|
66 Degrees
|
—
|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
12-months Thoracic Kyphosis (TK) (degrees)
|
78 Degrees
|
—
|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
Baseline Thoracolumbar kyphosis (TLK) (degrees)
|
41 Degrees
|
—
|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
12-months Thoracolumbar kyphosis (TLK) (degrees)
|
5 Degrees
|
—
|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
Baseline Lumbar lordosis (LL) (degrees)
|
50 Degrees
|
—
|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
12-months Lumbar Lordosis (LL) (degrees)
|
58 Degrees
|
—
|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
Baseline Pelvic Incidence (PI) (degrees)
|
46 Degrees
|
—
|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
12-months Pelvic Incidence (PI) (degrees)
|
50 Degrees
|
—
|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
Baseline Pelvic Tilt (PT) (degrees)
|
23 Degrees
|
—
|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
12-months Pelvic Tilt (PT) (degrees)
|
23 Degrees
|
—
|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
Baseline Sacral Slope (SS) (degrees)
|
23 Degrees
|
—
|
|
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
12-months Sacral Slope (SS) (degrees)
|
27 Degrees
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 1 subject who completed the 12 month follow-up visit was analyzed.
Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: * Coronal alignment : Distance between C7 plumb line and the central sacral vertical line * Sagittal alignment - Global parameter: Sagittal vertical axis (SVA)
Outcome measures
| Measure |
Degenerative Spinal Disease
n=1 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.
Baseline Coronal alignment (mm)
|
19.0 mm
|
—
|
|
For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.
12-months Coronal alignment (mm)
|
4.0 mm
|
—
|
|
For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.
Baseline Sagittal vertical axis (SVA) (mm)
|
43.0 mm
|
—
|
|
For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.
12-months Sagittal vertical axis (SVA) (mm)
|
49.0 mm
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 1 subject who completed the 12 month follow-up visit was analyzed.
Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray: \- Coronal Curve Type Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as: * Curve type L: patients with a lumbar or thoracolumbar major curve \>30˚ (apical level of T10 or lower) * Curve type T: patients with a thoracic major curve of \>30˚ (apical level of T9 or higher) * Curve type D: patients with a double major curve, with each curve \>30˚. * Curve type N: patients with no coronal curve \>30˚.
Outcome measures
| Measure |
Degenerative Spinal Disease
n=1 Participants
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
Baseline curve type L
|
1 Participants
|
—
|
|
For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
12-months curve type L
|
1 Participants
|
—
|
|
For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
Baseline curve type T
|
0 Participants
|
—
|
|
For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
12-months curve type T
|
0 Participants
|
—
|
|
For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
Baseline curve type D
|
0 Participants
|
—
|
|
For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
12-months curve type D
|
0 Participants
|
—
|
|
For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
Baseline curve type N
|
0 Participants
|
—
|
|
For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
12-months curve type N
|
0 Participants
|
—
|
Adverse Events
Degenerative Spinal Disease
Deformity
Serious adverse events
| Measure |
Degenerative Spinal Disease
n=11 participants at risk
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=10 participants at risk
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Nervous system disorders
SPINAL CSF LEAK
|
0.00%
0/11 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
10.0%
1/10 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
0.00%
0/11 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
10.0%
1/10 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
FORAMINAL STENOSIS
|
0.00%
0/11 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
10.0%
1/10 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
|
Injury, poisoning and procedural complications
INCISION WOUND DEHISCENCE
|
0.00%
0/11 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
10.0%
1/10 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE AT LEVEL T12
|
9.1%
1/11 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
0.00%
0/10 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/11 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
10.0%
1/10 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/11 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
10.0%
1/10 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
Other adverse events
| Measure |
Degenerative Spinal Disease
n=11 participants at risk
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).
|
Deformity
n=10 participants at risk
Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).
|
|---|---|---|
|
Injury, poisoning and procedural complications
PROXIMAL JUNCTIONAL KYPHOSIS
|
0.00%
0/11 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
10.0%
1/10 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/11 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
10.0%
1/10 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
|
Vascular disorders
HEMATOMA AT INDEX LEVEL CAUSING FEVER ABOVE 37.8°C
|
9.1%
1/11 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
0.00%
0/10 • The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60