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A Comparative study for construct placement based on reconstructed radiological images or 3D printed model for CV junction fixation surgery

An assessment of the accuracy of the construct placement during CV junction (CVJ) surgery using CT reconstructed images Vs 3D printed model: A Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036127
Enrollment
80
Registered
2021-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: S121- Fracture of second cervical vertebra Health Condition 2: M992- Subluxation stenosis of neural canal

Interventions

Intervention1: Group-A (Customised 3D printed group): After patient selection (as per CONSORT guidelines), The patient will undergo operative procedure based on the conventional radiology with customi

Sponsors

Sanjay Gandhi Postgraduate Institute of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All cases of congenital cv junction anomalies, 2. Traumatic C2 fracture requiring posterior fixation

Exclusion criteria

Exclusion criteria: 1. Recurrent cases, 2. Patient below 7 years and more than 70 years, 3. Tumour pathology, 4. Patient undergone for oral decompression, 5. Patient need emergency surgery for disease

Design outcomes

Primary

MeasureTime frame
â?¢ Clinical outcome- Power (modified Nurick grade), spasticity(modified Ashworth grade) and Neck Disability Index score â?¢ Radiological outcome â?? Screws position - Screw breech should be measured as per Hojo grading Change in ADI, Chamberlaneâ??s line and Wackenhamâ??s clivus canal lineParameters Timepoint: At the 5th post op day during admission.

Secondary

MeasureTime frame
This study will not only be helpful in establishing the role of customized 3D printed models in CV junction surgery but also be helpful in changing the contemporary practice of CV junction surgery. This study will not only be helpful in establishing the role of customized 3D printed models in CV junction surgery but also be helpful in changing the contemporary practice of CV junction surgery.Timepoint: Before and after discharge of patient.

Countries

India

Contacts

Public ContactPawan Kumar Verma

Sanjay Gandhi Postgraduate Institute of medical sciences, Lucknow

pawank@sgpgi.ac.in9549338064

Outcome results

None listed

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