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

Not Applicable

Completed

• Conditions: Closed Frykman Type II Fracture of Right Radial Head

• Registration Number: NCT02410070
• Lead Sponsor: The Second Hospital of Qinhuangdao

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Status Verified: 2015-03
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-04-01
• Last Update Submitted: 2015-04-01
• Study First Posted: 2015-04-07
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
grip strength of the hand	2 years	Assessment of grip strength of the hand using a Baseline hydraulic hand dynamometer, at 2 years follow-up.
pronation strength of the forearm	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.