Randomised control trial Comparing patient-specific surgical guides (PSSG) and conventional free-hand surgical methods in resource-constrained environment.

Randomised control trial on precision and performance of 3D-printed patient-specific surgical guides (PSSG) in resource-constrained environments in comparison to conventional free-hand surgical methods.

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083692

Enrollment

Registered

2025-03-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: G55- Nerve root and plexus compressionsin diseases classified elsewhere

Interventions

Intervention1: 3D printed patient specific pedicle screw guide: 3D printed patient specific pedicle screw guide will be used for surgery and its accuracy will be measured post operatively Interventio

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing thoracic and lumbar pedicle screw fixation for traumatic and degenerative spinal disease. Age more Than 18 years. Informed consent obtained

Exclusion criteria

Exclusion criteria: Previous spinal surgery in the same level Severe comorbidities that could affect healing or outcomes Congenital deformities of spine Pregnancy

Design outcomes

Primary

Measure	Time frame
1)Accuracy of the surgical procedure 2)Measurement: Post-operative imaging (e.g., CT or X-ray) to assess medial, lateral, superior or inferior breach. Secondary Outcomes: Operative time (measured in minutes) Blood Loss radiation exposure (number of shoots required) Cost in Indian rupees Timepoint: At admission preop , post op at 1 week, at 3 months	—

Secondary

Measure	Time frame
1)Accuracy of the surgical procedure 2)Measurement: Post-operative imaging (e.g., CT or X-ray) to assess medial, lateral, superior or inferior breach. Secondary Outcomes: Operative time (measured in minutes) Blood Loss radiation exposure (number of shoots required) Cost in Indian rupees Timepoint: At admission preop , post op at 1 week, at 3 months	—

Countries

India

Contacts

Public ContactVipin Chandran C

BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL

bcmchneurosx@gmail.com9496369301

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026