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

April 1, 2015 updated by: The Second Hospital of Qinhuangdao
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Though Volar Minimal Incision
Patients in group A were treated through a small Incision.
Procedure: Incision
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.
Active Comparator: Though Convectional Incision
Patients in group B were treated through the conventional Incision
Procedure: Incision
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Qinhuangdao

Investigators

  • Study Chair: Xu Zhang, MD, The Second Hospital of Qinhunangdao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 1, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1011126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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