Health Condition 1: M479- Spondylosis, unspecified
Conditions
Interventions
Intervention1: Cervical plate and cage system: Study participants will be followed at 6 week, 6 month and 12 month.
Control Intervention1: NIL: NIL
Sponsors
Auxein Medical Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients presenting to Orthopaedic OPD/emergency, requiring treatment with anterior cervical plate or/and cage.Specific indications include: 1. Single level tuberculosis 2. Cervical mylopathy 3. Tumor 4. Trauma 5. Single level degenerative disc disease
Exclusion criteria
Exclusion criteria: 1. Patients with active local or systemic infection. 2. Patients with morbid obesity BMI more than 35 kg/m2. 3. Patients with mental disorders or currently on psychiatric treatment. 4. Alcoholics and or drug abusers. 5. Patients with metabolic bone disease. 6. Severe osteopenia 7. Metal sensitivity or allergies 8. Pregnant women or those planning pregnancy during study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Radiological evaluation by X - rays to calculate meantime to achieve deformity correction/bone fusion. 2. Follow-up of the patient’s recovery by analyzing Visual analogue scale (VAS) for pain assessment.Timepoint: 6 week, 6 month, and 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in quality of life through Neck disability index (NDI). 2. Evaluation of safety of device by record of any adverse event, serious adverse event.Timepoint: 6 week, 6 month, and 12 month | — |
Countries
India
Contacts
Public ContactMr Gaurav Luthra
Auxein Medical Private Limited
Outcome results
None listed