Health Condition 1: M95-M95- Other disorders of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: Indigenous Spine Navigation System (Generic name: Computer Assisted Surgery System): A novel, indigenously developed optical navigation platform designed for spine surgery, utilizing re
Sponsors
Ganga Medical AI Private Limited
Healthcare Technology Innovation Centre IIT Madras
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject is Diagnosed with required disease /symptoms with requirement of surgical intervention when able to rigidly attach reference markers, and stereotactic surgery may be possible 2.Female patient in childbearing age has a negative urine pregnancy test on the day of the procedure 3.The subject (or a legally authorized representative) has provided written informed consent for study participation and procedures to be performed. 4.Signed written declaration of consent after oral and written explanation. 5.Able (in the Investigators opinion) and willing to comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1.Inability to obtain an informed consent from the subject (or a legally authorized representative) 2.Pregnant or breastfeeding women 3.Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant s ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was the accuracy of pedicle screw placement, defined as the proportion of screws achieving Grade A or B on the Gertzbein Robbins classification on postoperative CT imaging.Timepoint: Postoperative day 1 or when feasible. | — |
Secondary
| Measure | Time frame |
|---|---|
| Deviation from planned trajectory, measured as linear deviation (mm) from the intended entry point. Angular deviation (degrees) from the planned screw trajectory. Proportion of Grade A screws on the Gertzbein Robbins classification. Cortical breach rate and direction (medial, lateral, superior, inferior). Number of insertion attempts and first-pass success rate. Procedure-related metrics, including time for screw placement (system setup to final placement), total operative time (skin-to-skin), and intraoperative blood loss. Complications, including neurological, hardware-related, or other perioperative adverse events. Radiation exposure (if recorded). System usability, assessed using the System Usability Scale (SUS).Timepoint: Intraoperative time and Postoperative CT on day 1 or when feasible. | — |
Countries
India
Contacts
Public ContactGnanaprakash Gurusamy
Ganga Medical Centre and Hospital
Outcome results
None listed