OUTCOMES OF TWO APPROACHES OF TIBIAL NAILING A RANDOMIZED CONTROLLED TRIAL

Completed

• Conditions: Fracture of shaft of tibia, (2) ICD-10 Condition: S822||Fracture of shaft of tibia, (3) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2021/08/036086
• Lead Sponsor: AIIMS BHUABNESWAR

Brief Summary

Tibia shaft fractures are due to the high-end energytrauma and more common long bone to get fractured, approximately 2% of allfractures in adult. Presently reamed Intramedullary nailing of the tibia withadditional interlocking screws for the axial and rotational stability is preferredfor unstable tibia shaft fracture.

Traditionally,an infrapatellar port between the articular surface of the knee and tibialtubercle, lateral to tibial tubercle is practiced. Thisapproach requires cutting or splitting of the patellar tendon and sometimesthere is transection of theinfrapatellar nerve, a branch of the saphenous nerve during the procedure. Thisiatrogenic damage leads to anterior knee pain in few patients (10 to 80%). Also,due to the quadriceps extensor complex pull, the conical shape of tibialmetaphysis, and hyperflexion positioning intraoperatively, any angulated entry to the tibia during nailing leads tomalalignment and difficulty to maintain reduction for imaging.To overcomethese challenges, a novel entry port in a semi-extended kneeat a flexion of 15-20 degrees was proposed. This new Suprapatellar approach of tibial IntramedullaryInterlocking Nailing (IMILN) allows easy reduction, lesser fluoroscopy time,decreased malalignment, and reduces the anterior knee pain with equivalentfunctional outcome.

There are a few studies thatshow the superiority of Suprapatellar Approach (SPA) vs Infrapatellar Approach (IPA).These are majorly western literature and extensive research on the Indianpopulation is lacking. Hence a study to further declutter in the Indian setupis required.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-09
• Last Update Posted: 2023-07-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Isolated tibia shaft fractures 2.
• Skeletally matured, age >18 years.

Exclusion Criteria

1 multiple fractures of Ipsilateral limb 2.Refracture of tibia 3.Intra-articular tibia fractures 4.Arthritic knee 5.Open tibia shaft fractures 6.Neuromuscular diseases of lower limb 7.Pathological fractures 8.Any other complications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To access the functional outcome of tibia shaft fracture comparing the SPA and IPA in tibial intramedullary nailing using the Lysholm knee score.	3 momnths, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
To access the radiological outcome of tibia shaft fracture in terms of fracture reduction among the groups.

Trial Locations

Locations (1)

AIIMS Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

AIIMS Bhubaneswar

🇮🇳Khordha, ORISSA, India

Soyam S panda

Principal investigator

9090471731

sspanda.dr@gmail.com