Trial Outcomes & Findings for Pedicle Screw Positioning With MySpine vs Free Hand Technique (NCT NCT03369158)
NCT ID: NCT03369158
Last Updated: 2020-09-02
Results Overview
Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
1 week after surgery
Results posted on
2020-09-02
Participant Flow
Participant milestones
| Measure |
MySpine
Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"
patient specific pedicle screw positioning guide
MUST pedicle screw
|
Free Hand Technique
Patients operated for spinal stabilization through standard free hand technique
Free hand technique pedicle screw positioning
MUST pedicle screw
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MySpine
n=14 Participants
Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"
patient specific pedicle screw positioning guide
MUST pedicle screw
|
Free Hand Technique
n=15 Participants
Patients operated for spinal stabilization through standard free hand technique
Free hand technique pedicle screw positioning
MUST pedicle screw
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 15.3 • n=14 Participants
|
26 years
STANDARD_DEVIATION 17.2 • n=15 Participants
|
31 years
STANDARD_DEVIATION 16.2 • n=29 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=14 Participants
|
14 Participants
n=15 Participants
|
26 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=14 Participants
|
1 Participants
n=15 Participants
|
3 Participants
n=29 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
14 participants
n=14 Participants
|
15 participants
n=15 Participants
|
29 participants
n=29 Participants
|
PRIMARY outcome
Timeframe: 1 week after surgeryPedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.
Outcome measures
| Measure |
MySpine
n=297 screw
Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"
patient specific pedicle screw positioning guide
MUST pedicle screw
|
Free Hand Technique
n=243 screw
Patients operated for spinal stabilization through standard free hand technique
Free hand technique pedicle screw positioning
MUST pedicle screw
|
|---|---|---|
|
Accuracy of Pedicle Screw Positioning
|
90.24 percentage of screw
Interval 86.86 to 93.6
|
83.13 percentage of screw
Interval 78.42 to 87.84
|
SECONDARY outcome
Timeframe: 1 weeks after surgeryA CT will be performed before discharge to evaluate the severity of pedicle screws malposition according to Gertzbein in grades 0, A, B or C, with grades 0 or A considered as "safe area.". Level 0 (perfect corrected positioning of the screw), level A (0-2 mm of violation), level B (2-4 mm of violation), level C (˃4mm of violation). The better outcomes correspond to level 0 and the worst to level C.
Outcome measures
| Measure |
MySpine
n=297 screws
Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"
patient specific pedicle screw positioning guide
MUST pedicle screw
|
Free Hand Technique
n=243 screws
Patients operated for spinal stabilization through standard free hand technique
Free hand technique pedicle screw positioning
MUST pedicle screw
|
|---|---|---|
|
Radiological Evaluation of Pedicle Screw Malposition
Group 0
|
224 screws
|
160 screws
|
|
Radiological Evaluation of Pedicle Screw Malposition
Group A
|
44 screws
|
42 screws
|
|
Radiological Evaluation of Pedicle Screw Malposition
Group B
|
16 screws
|
19 screws
|
|
Radiological Evaluation of Pedicle Screw Malposition
Group C
|
13 screws
|
22 screws
|
SECONDARY outcome
Timeframe: 1 weeks after surgeryEvaluation of malposition on the medial or lateral side
Outcome measures
| Measure |
MySpine
n=297 screw
Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"
patient specific pedicle screw positioning guide
MUST pedicle screw
|
Free Hand Technique
n=243 screw
Patients operated for spinal stabilization through standard free hand technique
Free hand technique pedicle screw positioning
MUST pedicle screw
|
|---|---|---|
|
Occurrence of Malposition Side
Lateral misplacement
|
19 screws
|
31 screws
|
|
Occurrence of Malposition Side
Medial misplacement
|
46 screws
|
54 screws
|
SECONDARY outcome
Timeframe: intraoperatively, up to 1 week after surgeryOccurrence of intra-operative complications reporting
Outcome measures
| Measure |
MySpine
n=14 Participants
Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"
patient specific pedicle screw positioning guide
MUST pedicle screw
|
Free Hand Technique
n=15 Participants
Patients operated for spinal stabilization through standard free hand technique
Free hand technique pedicle screw positioning
MUST pedicle screw
|
|---|---|---|
|
Incidence of Adverse Event
|
0 Participants
|
0 Participants
|
Adverse Events
MySpine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Free Hand Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place