Performance and safety evaluation of pedicle screw for spinal disorders

A prospective single arm, multi-centric, post marketing clinical follow-up study to evaluate the safety and performance of pedicle screws in patient with spinal disorders

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/03/051092

Enrollment

159

Registered

2023-03-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M258- Other specified joint disorders

Interventions

Intervention1: Auxein Medical Pedicle Screw System: Pedicle Screw Implants Intended to be used in surgery for spine disorders Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for pedicle screw placement surgery. 2. The participant can understand and provide informed consent, and has signed their written informed consent. 3. Age between 18 - 60 years at the time of surgery

Exclusion criteria

Exclusion criteria: 1. Patients with pedicle deformity 2. Familial history Neurofibromatosis type 2 (NF2). 3. Metabolic bone disease. 4. History of Paget disease or other osteodystrophies whether acquired or congenital, including renal osteodystrophy, Ehrlers-Danlos- syndrome, osteogenesis imperfecta, achondroplasia. 5. History of mental disorder or current psychiatric treatment. 6. Pregnancy and/or female subjects intending to become pregnant within the expected time frame of the study and/or female subjects of child bearing age who do not use conventional contraceptive methods. 7. Immune deficiency disease 8. Scoliosis. 9. Lack of willingness to make a commitment to return for required follow up visits. 10. Drug and/or alcohol abuse. 11.ASA III and IV grade condition

Design outcomes

Primary

Measure	Time frame
The rate of pedicle screw loosening, [ Time Frame: 12 months post operatively ] A radiolucent zone, 1mm, surrounding the pedicle screw seen in CT ScanTimepoint: 3, 6, and 12 months postoperatively	—

Secondary

Measure	Time frame
Change in patient ?s function from baseline to 12 months [ Time Frame: 12 months ] Clinical outcome in function as measured by the 100 point Oswestry Disability Index (ODI).Timepoint: 3, 6, and 12 months postoperatively;Change in VAS score from baseline to 12 monthTimepoint: 3, 6 and 12 months postoperatively;Rate of implant related failure i.e. Rate of screw/rod breakageTimepoint: [ Time Frame: 12 months post operatively ]	—

Measure

Time frame

Change in patient ?s function from baseline to 12 months [ Time Frame: 12 months ] Clinical outcome in function as measured by the 100 point Oswestry Disability Index (ODI).Timepoint: 3, 6, and 12 months postoperatively;Change in VAS score from baseline to 12 monthTimepoint: 3, 6 and 12 months postoperatively;Rate of implant related failure i.e. Rate of screw/rod breakageTimepoint: [ Time Frame: 12 months post operatively ]

—

Countries

India

Contacts

Public ContactGaurav Luthra

Auxein Medical Pvt. Ltd

m.kumar@auxein.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026