Complications in Distal Radius Fracture
Primary Purpose
Radius Fracture Distal
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Percutaneous pinning time
Sponsored by
About this trial
This is an interventional treatment trial for Radius Fracture Distal focused on measuring Radius Fracture Distal, Radius Fracture Distal Therapy, Fracture fixation, Closed Fracture Reduction
Eligibility Criteria
Inclusion Criteria:
- patients older than 18 ages
- any gender
- distal radius fracture type A or B of AO classification managed with closed reduction and percutaneous pinning
- and Informed Consent signature
Exclusion Criteria:
- associated ipsilateral fractures in the upper extremity
- fractures attended and fixed at another institution
- support external fixation
- previous skin conditions (infection, ulcers)
- limitation of wrist mobility prior to injury
Sites / Locations
- Universidad Autonoma de Nuevo LeonRecruiting
- Universidad Autonoma de Nuevo LeonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3 week percutaneous pinning group
6 week percutaneous pinning group
Arm Description
Percutaneous pinning time will be for three weeks and short cast immobilization for six weeks.
Percutaneous pinning time will be for six weeks and also short cast immobilization.
Outcomes
Primary Outcome Measures
Visual Analogue Scale
It´s a numeric scale, when 0 value is equal to no pain; and 10 is equal to a maximum pain
Secondary Outcome Measures
Patient Rated Wrist Evaluation (PRWE)
It´s a 15- item questionnaire designed to measure wrist pain and disability in activities of daily living. developed in 1998 for clinical assessment and is used for specific wrist problems. It is one of the reliable upper extremity outcome instrument
Wrist mobility
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer.
Grip strength
Using a hydraulic dynamometer with the patient's elbow in 90 grades of flexion and forearm in neutral rotation.
Skin condition
Evaluation of skin condition and integrity, when normal is equal to 0, ulcer=1 and granuloma=2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03311633
Brief Title
Complications in Distal Radius Fracture
Official Title
Distal Radius Fracture: Comparison Between Three and Six Weeks of Percutaneous Fixation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
June 20, 2023 (Anticipated)
Study Completion Date
July 23, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carlos A Acosta-Olivo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
BACKGROUND. Distal radius fractures (FRD) are up to 17% of all diagnosed fractures and are the most commonly treated fractures in adult orthopedic patients. The management could be either conservative or surgical, depending on AO bone fracture classification. The principles of good treatment involves an anatomical reduction with a proper immobilization that keep the reduction.
OBJECTIVE. Determine if percutaneous pinning for six weeks versus three has major complications in distal radius fractures.
Detailed Description
Distal radius fractures (DRF) are up to 20% of all diagnosed fractures and are the most commonly treated fractures in adult orthopedic patients. DRF occur in distal third of the radius bone, located less than 2.5 cm from the radiocarpal joint. In general, it is the result of a fall on the hand in extension. A bimodal distribution is observed with a peak incidence predominantly in young adult patients and another peak in elderly women. In the younger population these fractures are usually the result of high-impact injuries such as vehicular accidents or high-altitude falls. This diagnosis in elderly most commonly occurs by falls from their own height and other low-energy trauma.
The management could be either conservative or surgical, depending on AO bone fracture classification. Regarding treatment, there is still much controversy as to what procedure would be ideal in each case. When selecting the therapeutic method, the patient's age, work, functional status and daily activities should be considered. Therapeutic alternatives differ considerably around the world and no technique has proven to be superior to all others, and there is no particular method that yields acceptable results in all types of DRF. The principles of good treatment involves an anatomical reduction with a proper immobilization that keep the reduction.
If segmental or unstable fractures are not treated properly, serious complications can occur. The rate of complications reported in the literature varies from 6 to 80% and these may be a consequence of the fracture or its treatment. There are many vital structures of soft tissue in close proximity to the bony anatomy around the wrist and the complications associated with these soft tissues may be more problematic than the fracture. Some surgical complications are loss of mobility, delayed consolidation, pseudoarthrosis, nerve compression, painful syndromes, complications of fixation material, osteomyelitis, vicious consolidation, tendon rupture, tenosynovitis, pathological scarring, radio-cubital synostosis, Dupuytren's contracture, arthritis and ligament injury. However, cutaneous complications such as ulcers or granulomas may occur at the site of nails, although not usually serious complications may prevent early rehabilitation of the patient and extend recovery times for incorporation into their daily activities.
Statistical analysis. The results will be reported in contingency tables, frequencies, percentages, measures of central tendency and dispersion. Qualitative variables will be analyzed with the chi-square statistic and quantitative variables with t-test for independent samples with a significance level of 95% with their respective confidence intervals, or with non-parametric statistics if necessary. Using a mean difference formula with a standard deviation of 5 and an expected magnitude of the differences of at least 4 points on the PRWE scale, with a confidence interval of 95%, a power β of 80%, with a statistically significant p = ˂0.05, adding 20% of error. A sample of 30 participants was obtained per group. For evaluation of pain (Visual Analogue Scale) and functional evaluation (Patient Rated Wrist Evaluation), the Student's T test and one-way ANOVA with Tuckey's post-hoc test will be performed for multiple comparisons in order to identify differences between groups. Statistical analysis will be performed with IBM SPSS version 20 (SPSS, Inc., Armon, NY).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fracture Distal
Keywords
Radius Fracture Distal, Radius Fracture Distal Therapy, Fracture fixation, Closed Fracture Reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three week percutaneous pinning group versus Six week percutaneous pinning group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3 week percutaneous pinning group
Arm Type
Experimental
Arm Description
Percutaneous pinning time will be for three weeks and short cast immobilization for six weeks.
Arm Title
6 week percutaneous pinning group
Arm Type
Active Comparator
Arm Description
Percutaneous pinning time will be for six weeks and also short cast immobilization.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous pinning time
Intervention Description
Percutaneous pinning time will be compared in two groups: 3 versus 6 weeks.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
It´s a numeric scale, when 0 value is equal to no pain; and 10 is equal to a maximum pain
Time Frame
14 week
Secondary Outcome Measure Information:
Title
Patient Rated Wrist Evaluation (PRWE)
Description
It´s a 15- item questionnaire designed to measure wrist pain and disability in activities of daily living. developed in 1998 for clinical assessment and is used for specific wrist problems. It is one of the reliable upper extremity outcome instrument
Time Frame
14 weeks
Title
Wrist mobility
Description
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer.
Time Frame
14 weeks
Title
Grip strength
Description
Using a hydraulic dynamometer with the patient's elbow in 90 grades of flexion and forearm in neutral rotation.
Time Frame
14 weeks
Title
Skin condition
Description
Evaluation of skin condition and integrity, when normal is equal to 0, ulcer=1 and granuloma=2
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients older than 18 ages
any gender
distal radius fracture type A or B of AO classification managed with closed reduction and percutaneous pinning
and Informed Consent signature
Exclusion Criteria:
associated ipsilateral fractures in the upper extremity
fractures attended and fixed at another institution
support external fixation
previous skin conditions (infection, ulcers)
limitation of wrist mobility prior to injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Acosta-Olivo, PhD
Phone
+518183476698
Email
dr.carlosacosta@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yadira Tamez-Mata, MD
Phone
+518183476698
Email
dra.yadiratamez@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Acosta-Olivo, PhD
Organizational Affiliation
Universidad Autonoma de Nuevo Leon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Autonoma de Nuevo Leon
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64480
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yadira Tamez-Mata, MD
Phone
528183467798
Email
htr.yad@gmail.com
Facility Name
Universidad Autonoma de Nuevo Leon
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
66460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Acosta-Olivo, PhD
Email
dr.carlosacosta@gmail.com
First Name & Middle Initial & Last Name & Degree
Yadira Tamez-Mata, MD
Email
dra.yadiratamez@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not yet decided
Citations:
PubMed Identifier
25143645
Citation
Tahririan MA, Javdan M, Motififard M. Results of pronator quadratus repair in distal radius fractures to prevent tendon ruptures. Indian J Orthop. 2014 Jul;48(4):399-403. doi: 10.4103/0019-5413.136275.
Results Reference
result
PubMed Identifier
23026468
Citation
Niver GE, Ilyas AM. Carpal tunnel syndrome after distal radius fracture. Orthop Clin North Am. 2012 Oct;43(4):521-7. doi: 10.1016/j.ocl.2012.07.021. Epub 2012 Sep 4.
Results Reference
result
PubMed Identifier
25030810
Citation
Dhainaut A, Daibes K, Odinsson A, Hoff M, Syversen U, Haugeberg G. Exploring the relationship between bone density and severity of distal radius fragility fracture in women. J Orthop Surg Res. 2014 Jul 17;9:57. doi: 10.1186/s13018-014-0057-8.
Results Reference
result
PubMed Identifier
24651288
Citation
Henn CM, Wolfe SW. Distal radius fractures in athletes: approaches and treatment considerations. Sports Med Arthrosc Rev. 2014 Mar;22(1):29-38. doi: 10.1097/JSA.0000000000000003.
Results Reference
result
PubMed Identifier
17560404
Citation
Turner RG, Faber KJ, Athwal GS. Complications of distal radius fractures. Orthop Clin North Am. 2007 Apr;38(2):217-28, vi. doi: 10.1016/j.ocl.2007.02.002.
Results Reference
result
PubMed Identifier
20494749
Citation
Davis DI, Baratz M. Soft tissue complications of distal radius fractures. Hand Clin. 2010 May;26(2):229-35. doi: 10.1016/j.hcl.2009.11.002.
Results Reference
result
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Complications in Distal Radius Fracture
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