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Completed

NCT Number: NCT02410070

A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures

The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

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Key information

Conditions

Closed Frykman Type II Fracture of Right Radial Head

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

From January 2011 to September 2012, 157 patients with distal radial fractures were allocated into group A (n=83) and B (n=74). Patients in group A were treated through a 1.5 to 2-cm long incision, and patients in group B were treated through the conventional flexor carpi radialis approach. All fractures were fixed with volar plates. Patients were assessed range of motion of the wrist, grip strength of the hand, and pronation strength of the wrist. Results were analyzed with the Statistical Package for Social Sciences 13.0. A P < 0.05 was statistically significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fernandez type II-IV radial fractures.

Exclusion criteria

  • Fernandez type I radial fracture.
  • Fernandez type V radial fracture.
  • Open radial fractures.
  • Surgery using K-wires or screws alone.
  • The use of external fixators.
  • multiple fractures, pathological fracture.

Treatment and study plan

incision

Procedure

The objective of this report is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

Primary outcomes

  1. range of motion of the wrist

    Time frame: 2 years

    measurement of range of motion of the wrist with a goniometer, at 2 years follow-up.

Secondary outcomes

  1. grip strength of the hand

    Time frame: 2 years

    Assessment of grip strength of the hand using a Baseline hydraulic hand dynamometer, at 2 years follow-up.

  2. pronation strength of the forearm

    Time frame: 2 years

    Isometric testing of pronation torque, McConkey method at 5 positions of rotation (90° of supination, 45° of supination, neutral, 45° of pronation, and 80° of pronation) , at 2 years follow-up.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Qinhuangdao

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Apr 7, 2015
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.