Back to resultsA Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures
Primary Purpose
Closed Frykman Type II Fracture of Right Radial Head
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Incision
Sponsored by
About this trial
This is an interventional treatment trial for Closed Frykman Type II Fracture of Right Radial Head focused on measuring Distal radial fracture, pronator quadratus, mini-approach, volar plating, open reduction and internal fixation
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Though Volar Minimal Incision
Though Convectional Incision
Arm Description
Patients in group A were treated through a small Incision.
Patients in group B were treated through the conventional Incision
Outcomes
Primary Outcome Measures
range of motion of the wrist
measurement of range of motion of the wrist with a goniometer, at 2 years follow-up.
Secondary Outcome Measures
grip strength of the hand
Assessment of grip strength of the hand using a Baseline hydraulic hand dynamometer, at 2 years follow-up.
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.
Full Information
NCT ID
NCT02410070
First Posted
March 18, 2015
Last Updated
April 1, 2015
Sponsor
The Second Hospital of Qinhuangdao
1. Study Identification
Unique Protocol Identification Number
NCT02410070
Brief Title
A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures
Official Title
A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Qinhuangdao
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Frykman Type II Fracture of Right Radial Head
Keywords
Distal radial fracture, pronator quadratus, mini-approach, volar plating, open reduction and internal fixation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Though Volar Minimal Incision
Arm Type
Experimental
Arm Description
Patients in group A were treated through a small Incision.
Arm Title
Though Convectional Incision
Arm Type
Active Comparator
Arm Description
Patients in group B were treated through the conventional Incision
Intervention Type
Procedure
Intervention Name(s)
Incision
Intervention Description
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 Outcome Measure Information:
Title
range of motion of the wrist
Description
measurement of range of motion of the wrist with a goniometer, at 2 years follow-up.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
grip strength of the hand
Description
Assessment of grip strength of the hand using a Baseline hydraulic hand dynamometer, at 2 years follow-up.
Time Frame
2 years
Title
pronation strength of the forearm
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Zhang, MD
Organizational Affiliation
The Second Hospital of Qinhunangdao
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
23918414
Citation
Skouras E, Hosseini Y, Berger V, Wegmann K, Koslowsky TC. Operative treatment and outcome of unstable distal radial fractures using a palmar T-miniplate at a non-specialized institution. Strategies Trauma Limb Reconstr. 2013 Nov;8(3):155-60. doi: 10.1007/s11751-013-0170-y. Epub 2013 Aug 6.
Results Reference
result
PubMed Identifier
18656773
Citation
Protopsaltis TS, Ruch DS. Volar approach to distal radius fractures. J Hand Surg Am. 2008 Jul-Aug;33(6):958-65. doi: 10.1016/j.jhsa.2008.04.018.
Results Reference
result
Learn more about this trial
A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures
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