Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-02 @ 2:13 PM
Study NCT ID:
NCT03369158
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pedicle Screw Positioning With MySpine vs Free Hand Technique
Sponsor:
Medacta International SA
Organization:
Study Overview
Official Title:
A Prospective Clinical Survey on Accuracy of Pedicle Screws Positioning With MySpine Versus Free Hand Technique
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: