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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MySpine | Experimental | Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine" |
|
| Free hand technique | Active Comparator | Patients operated for spinal stabilization through standard free hand technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient specific pedicle screw positioning guide | Procedure |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | MySpine | Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine" patient specific pedicle screw positioning guide MUST pedicle screw |
| FG001 | Free Hand Technique | Patients operated for spinal stabilization through standard free hand technique Free hand technique pedicle screw positioning MUST pedicle screw |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MySpine | Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine" patient specific pedicle screw positioning guide MUST pedicle screw |
| BG001 | Free Hand Technique |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy of Pedicle Screw Positioning | Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle. | Posted | Number | 95% Confidence Interval | percentage of screw | 1 week after surgery | screw | screw |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MySpine | Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine" patient specific pedicle screw positioning guide MUST pedicle screw |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Data Manager | Medacta International | +41 91 696 60 60 | bonacina@medacta.ch |
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| Free hand technique pedicle screw positioning |
| Procedure |
|
| MUST pedicle screw | Device |
|
| 1 weeks after surgery |
| Occurrence of Malposition Side | Evaluation of malposition on the medial or lateral side | 1 weeks after surgery |
| Incidence of Adverse Event | Occurrence of intra-operative complications reporting | intraoperatively, up to 1 week after surgery |
Patients operated for spinal stabilization through standard free hand technique
Free hand technique pedicle screw positioning
MUST pedicle screw
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| screw |
|
|
| Secondary | 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. | Posted | Count of Units | screws | 1 weeks after surgery | screws | screws |
|
|
|
| Secondary | Occurrence of Malposition Side | Evaluation of malposition on the medial or lateral side | Posted | Number | screws | 1 weeks after surgery | screw | screw |
|
|
|
| Secondary | Incidence of Adverse Event | Occurrence of intra-operative complications reporting | Posted | Count of Participants | Participants | intraoperatively, up to 1 week after surgery |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Free Hand Technique | Patients operated for spinal stabilization through standard free hand technique Free hand technique pedicle screw positioning MUST pedicle screw | 0 | 15 | 0 | 15 | 0 | 15 |
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| Group B |
|
| Group C |
|