Spinal Deformity
Conditions
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.
Interventions
PROCEDUREpatient specific pedicle screw positioning guide
PROCEDUREFree hand technique pedicle screw positioning
DEVICEMUST pedicle screw
Sponsors
Medacta International SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Pedicle Screw Positioning | 1 week after surgery | Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiological Evaluation of Pedicle Screw Malposition | 1 weeks after surgery | 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 | 1 weeks after surgery | Evaluation of malposition on the medial or lateral side |
| Incidence of Adverse Event | intraoperatively, up to 1 week after surgery | Occurrence of intra-operative complications reporting |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MySpine Patients operated for spinal stabilization through patient specific pedicle screw guide MySpine
patient specific pedicle screw positioning guide
MUST pedicle screw | 14 |
| Free Hand Technique Patients operated for spinal stabilization through standard free hand technique
Free hand technique pedicle screw positioning
MUST pedicle screw | 15 |
| Total | 29 |
Baseline characteristics
| Characteristic | Free Hand Technique | Total | MySpine |
|---|---|---|---|
| Age, Continuous | 26 years STANDARD_DEVIATION 17.2 | 31 years STANDARD_DEVIATION 16.2 | 34 years STANDARD_DEVIATION 15.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Italy | 15 participants | 29 participants | 14 participants |
| Sex: Female, Male Female | 14 Participants | 26 Participants | 12 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 15 |
| other Total, other adverse events | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 14 | 0 / 15 |
Outcome results
Primary
Accuracy of Pedicle Screw Positioning
Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.
Time frame: 1 week after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MySpine | Accuracy of Pedicle Screw Positioning | 90.24 percentage of screw |
| Free Hand Technique | Accuracy of Pedicle Screw Positioning | 83.13 percentage of screw |
Secondary
Incidence of Adverse Event
Occurrence of intra-operative complications reporting
Time frame: intraoperatively, up to 1 week after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MySpine | Incidence of Adverse Event | 0 Participants |
| Free Hand Technique | Incidence of Adverse Event | 0 Participants |
Secondary
Occurrence of Malposition Side
Evaluation of malposition on the medial or lateral side
Time frame: 1 weeks after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MySpine | Occurrence of Malposition Side | Lateral misplacement | 19 screws |
| MySpine | Occurrence of Malposition Side | Medial misplacement | 46 screws |
| Free Hand Technique | Occurrence of Malposition Side | Lateral misplacement | 31 screws |
| Free Hand Technique | Occurrence of Malposition Side | Medial misplacement | 54 screws |
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.
Time frame: 1 weeks after surgery
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| MySpine | Radiological Evaluation of Pedicle Screw Malposition | Group C | 13 screws |
| MySpine | Radiological Evaluation of Pedicle Screw Malposition | Group 0 | 224 screws |
| MySpine | Radiological Evaluation of Pedicle Screw Malposition | Group A | 44 screws |
| MySpine | Radiological Evaluation of Pedicle Screw Malposition | Group B | 16 screws |
| Free Hand Technique | Radiological Evaluation of Pedicle Screw Malposition | Group B | 19 screws |
| Free Hand Technique | Radiological Evaluation of Pedicle Screw Malposition | Group C | 22 screws |
| Free Hand Technique | Radiological Evaluation of Pedicle Screw Malposition | Group A | 42 screws |
| Free Hand Technique | Radiological Evaluation of Pedicle Screw Malposition | Group 0 | 160 screws |