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RASPUTIN - Rotational Alignment in tibia diaphyseal fractures with the SupraPatellar Semi-extended Versus Standard Upper Entry Tibial Intramedullary Nailing: A Randomized Controlled Trial

Rotational alignment in tibia diaphyseal fractures with the Suprapatellar Semi-extended Versus Standard Infrapatellar Entry Tibial Nailing Techniques: A Randomized Controlled Trial - RASPUTIN

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035939
Enrollment
100
Registered
2021-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: S822- Fracture of shaft of tibia Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Suprapatellar Nailing: This technique requires the leg to be maintained in semi-extended position during the surgery. Duration-the intervention is just a different entry point technique

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult (18 years or older) Tibia fractures planned for intramedullary nailing. 2. Patients presenting to casualty or OPD. 3. All tibial diaphyseal fractures, AO Classification 42A1, A2 and A3, 43A

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years. 2. Open fractures presenting >48 hours from time of injury. 3. Ipsilateral femur fractures and contralateral tibia fractures 4. Gustillo Anderson Type IIIc injuries. 5. AO 41, 43 B and 43 C fractures. 6. Pathological fractures. 7. Severe osteoarthritis of the knee

Design outcomes

Primary

MeasureTime frame
1. Measure post-operative rotational alignment with CT scan axial images. 2. Measure post-operative sagittal and coronal plane alignment with plane radiographsTimepoint: Prior to discharge following surgery

Secondary

MeasureTime frame
Anterior knee painTimepoint: 6 weeks, 3 months and 6 months;ComplicationsTimepoint: During post operative follow up;Knee function by a Lysholm scoreTimepoint: 6 weeks, 3 months and 6 months;Knee range of motionTimepoint: 6 weeks, 3 months and 6 months;Operative timeTimepoint: Immediate post operative period;Radiation exposureTimepoint: Immediate post operative period;Time to unionTimepoint: During post operative follow up

Countries

India

Contacts

Public ContactDr Viju Daniel Varghese

Christian Medical College, Vellore

viju.daniel@gmail.com9344566387

Outcome results

None listed

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