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Not yet recruiting NCT07657559

RCT - Suprapatellar Approach Versus Lateral Parapatellar Approach in Tibial Shaft Fracture

No phase Interventional Tibial Shaft Fracture Intramedullary Nail

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: suprapatellar approach, extra-articular lateral parapatellar approach.
Who it may be relevant to
Registry conditions: Tibial Shaft Fracture, Intramedullary Nail. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Suprapatellar Approach Versus Extra-articular Lateral Parapatellar Approach in Tibial Shaft Fractures: A Randomized Controlled Trial

Overview

This study aims to compare 2 surgical techniques for tibial shaft nailing (suprapatellar approach vs extra-articular lateral parapatellar approach). following peri-operative and postoperative outcomes

Detailed description

This is a randomized controlled trial study, compared extra-articular lateral parapatellar approach with suprapatellar approach in tibial shaft nailing. peri-operative data are operative time, blood loss, fluoroscopy time, hospital stay. post-operative outcomes include Lysholm Knee Score, VAS-knee, range of motion. these outcomes are following postoperative day 1, 2 weeks, 6 weeks, 3 months and 6 months.

Interventions

  • Procedure suprapatellar approach
    semi-extended position longitudinal incision 2 cm. above patella nail insertion procedure under patellofemoral joint
  • Procedure extra-articular lateral parapatellar approach
    semi-extended position longitudinal incision 4-5 cm., lateral to patellar tendon nail insertion procedure

Primary outcome measures

  • Lysholm Knee Score [Time frame: 6 months]
Secondary outcome measures (5)
  • operative time [Time frame: operation]
  • VAS score of knee [Time frame: POD 1, 2 weeks, 6 weeks, 3 months, 6 months]
  • range of motion [Time frame: POD 1, 2 weeks, 6 weeks, 3 months, 6 months]
  • intraoperative blood loss [Time frame: operation]
  • fluoroscopy time [Time frame: operation]

Eligibility criteria

Inclusion criteria

  • age 18-60 years
  • tibial shaft fractures

Exclusion criteria

  • pervious knee injury
  • open fracture at least Gustilo grade II
  • ipsilateral femur and ankle fractures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07657559 · 016/2567

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗