Back to resultsPedicle Screw Positioning With MySpine vs Free Hand Technique
Primary Purpose
Spinal Deformity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
patient specific pedicle screw positioning guide
Free hand technique pedicle screw positioning
MUST pedicle screw
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Deformity
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MySpine
Free hand technique
Arm Description
Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"
Patients operated for spinal stabilization through standard free hand technique
Outcomes
Primary Outcome Measures
Accuracy of Pedicle Screw Positioning
Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.
Secondary Outcome Measures
Radiological Evaluation of Pedicle Screw Malposition
A 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.
Occurrence of Malposition Side
Evaluation of malposition on the medial or lateral side
Incidence of Adverse Event
Occurrence of intra-operative complications reporting
Full Information
NCT ID
NCT03369158
First Posted
November 28, 2017
Last Updated
August 18, 2020
Sponsor
Medacta International SA
1. Study Identification
Unique Protocol Identification Number
NCT03369158
Brief Title
Pedicle Screw Positioning With MySpine vs Free Hand Technique
Official Title
A Prospective Clinical Survey on Accuracy of Pedicle Screws Positioning With MySpine Versus Free Hand Technique
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 13, 2015 (Actual)
Primary Completion Date
October 11, 2016 (Actual)
Study Completion Date
February 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medacta International SA
4. Oversight
5. Study Description
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.
Detailed Description
The proposed study seeks to assess the intraoperative accuracy of the Medacta patient-specific MySpine® pedicle screws placement guides in comparison to free-hand technique.
A pre-operative CT scan of the spine is obtained to create a 3-dimensional model of the patient's spine for the MySpine patient group. This model is then used to preoperatively plan the patient's surgery implantation itself, with the same goals of both free-hand and computer assisted techniques. The theoretical advantage of this technique is accurate implant placement without the added surgical time and complexity of the procedure, with lower radiation exposure thanks to less steps of fluoroscopy checks.
The hypothesis for the present study is that the MySpine® technique can place pedicle screws more accurately in comparison to free-hand technique.
The accuracy of the final implant position with respect to the pre-operative planning will be evaluated through CT post-op analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Deformity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MySpine
Arm Type
Experimental
Arm Description
Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"
Arm Title
Free hand technique
Arm Type
Active Comparator
Arm Description
Patients operated for spinal stabilization through standard free hand technique
Intervention Type
Procedure
Intervention Name(s)
patient specific pedicle screw positioning guide
Other Intervention Name(s)
MySpine
Intervention Type
Procedure
Intervention Name(s)
Free hand technique pedicle screw positioning
Intervention Type
Device
Intervention Name(s)
MUST pedicle screw
Primary Outcome Measure Information:
Title
Accuracy of Pedicle Screw Positioning
Description
Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.
Time Frame
1 week after surgery
Secondary Outcome Measure Information:
Title
Radiological Evaluation of Pedicle Screw Malposition
Description
A 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.
Time Frame
1 weeks after surgery
Title
Occurrence of Malposition Side
Description
Evaluation of malposition on the medial or lateral side
Time Frame
1 weeks after surgery
Title
Incidence of Adverse Event
Description
Occurrence of intra-operative complications reporting
Time Frame
intraoperatively, up to 1 week after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
Pedicle Screw Positioning With MySpine vs Free Hand Technique
We'll reach out to this number within 24 hrs