Performance and safety evaluation of pedicle screw for spinal disorders
- Conditions
- Health Condition 1: M258- Other specified joint disorders
- Registration Number
- CTRI/2023/03/051092
- Lead Sponsor
- Auxein Medical Pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method