Pedicle Screw Positioning With MySpine vs Free Hand Technique
A Prospective Clinical Survey on Accuracy of Pedicle Screws Positioning With MySpine Versus Free Hand Technique
1 other identifier
interventional
29
0 countries
N/A
Brief Summary
Randomized clinical study in order to evaluate the accuracy of pedicle screw positioning during spine surgery performed with MySpine patient match positioning guide or Free hand technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2017
CompletedFirst Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 11, 2017
CompletedResults Posted
Study results publicly available
September 2, 2020
CompletedSeptember 2, 2020
November 1, 2017
1.7 years
November 28, 2017
February 19, 2020
August 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy of Pedicle Screw Positioning
Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.
1 week after surgery
Secondary Outcomes (3)
Radiological Evaluation of Pedicle Screw Malposition
1 weeks after surgery
Occurrence of Malposition Side
1 weeks after surgery
Incidence of Adverse Event
intraoperatively, up to 1 week after surgery
Study Arms (2)
MySpine
EXPERIMENTALPatients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"
Free hand technique
ACTIVE COMPARATORPatients operated for spinal stabilization through standard free hand technique
Interventions
Eligibility Criteria
You may qualify if:
- Patients older than 12 years
- patients suffering from coronal or sagittal spinal deformities that will undergo a surgical treatment with a posterior approach and pedicle screws placement
- Patients suitable to undergo spinal stabilization (according to the label indication/contraindications)
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained when indication to surgery is confirmed.
You may not qualify if:
- Patient with congenital spinal deformity (emeverebre, vertebra wedge, vertebrate butterfly, congenital bar, vertebra block)
- Patients with a previous fusion of the spine in the region where screws will be inserted
- Patients with any allergy to the device implanted
- Patients who will be not able to provide their written consent to the study participation
- Patients who are incapable of understanding and wanting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Results Point of Contact
- Title
- Clinical Data Manager
- Organization
- Medacta International
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 11, 2017
Study Start
January 13, 2015
Primary Completion
October 11, 2016
Study Completion
February 13, 2017
Last Updated
September 2, 2020
Results First Posted
September 2, 2020
Record last verified: 2017-11