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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Closed Frykman Type II Fracture of Right Radial Head

Intervention / Treatment
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* Procedure: Incision


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of motion of the wrist | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal radial fracture, pronator quadratus, mini-approach, volar plating, open reduction and internal fixation