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Complications in Distal Radius Fracture

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ClinicalTrials.gov Identifier: NCT03311633
Recruitment Status : Recruiting
First Posted : October 17, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

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.


Condition or disease Intervention/treatment Phase
Radius Fracture Distal Procedure: Percutaneous pinning time Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three week percutaneous pinning group versus Six week percutaneous pinning group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Distal Radius Fracture: Comparison Between Three and Six Weeks of Percutaneous Fixation
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3 week percutaneous pinning group
Percutaneous pinning time will be for three weeks and short cast immobilization for six weeks.
Procedure: Percutaneous pinning time
Percutaneous pinning time will be compared in two groups: 3 versus 6 weeks.

Active Comparator: 6 week percutaneous pinning group
Percutaneous pinning time will be for six weeks and also short cast immobilization.
Procedure: Percutaneous pinning time
Percutaneous pinning time will be compared in two groups: 3 versus 6 weeks.




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 14 week ]
    It´s a numeric scale, when 0 value is equal to no pain; and 10 is equal to a maximum pain


Secondary Outcome Measures :
  1. Patient Rated Wrist Evaluation (PRWE) [ Time Frame: 14 weeks ]
    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

  2. Wrist mobility [ Time Frame: 14 weeks ]
    Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer.

  3. Grip strength [ Time Frame: 14 weeks ]
    Using a hydraulic dynamometer with the patient's elbow in 90 grades of flexion and forearm in neutral rotation.

  4. Skin condition [ Time Frame: 6 weeks ]
    Evaluation of skin condition and integrity, when normal is equal to 0, ulcer=1 and granuloma=2



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311633


Contacts
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Contact: Carlos Acosta-Olivo, PhD +518183476698 dr.carlosacosta@gmail.com
Contact: Yadira Tamez-Mata, MD +518183476698 dra.yadiratamez@gmail.com

Locations
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Mexico
Universidad Autonoma de Nuevo Leon Recruiting
Monterrey, Nuevo Leon, Mexico, 64480
Contact: Yadira Tamez-Mata, MD    528183467798    htr.yad@gmail.com   
Universidad Autonoma de Nuevo Leon Recruiting
Monterrey, Nuevo Leon, Mexico, 66460
Contact: Carlos Acosta-Olivo, PhD       dr.carlosacosta@gmail.com   
Contact: Yadira Tamez-Mata, MD       dra.yadiratamez@gmail.com   
Sponsors and Collaborators
Carlos A Acosta-Olivo
Investigators
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Principal Investigator: Carlos Acosta-Olivo, PhD Universidad Autonoma de Nuevo Leon

Publications of Results:
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Responsible Party: Carlos A Acosta-Olivo, Principal Investigator, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT03311633     History of Changes
Other Study ID Numbers: OR17-00011
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not yet decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon:
Radius Fracture Distal
Radius Fracture Distal Therapy
Fracture fixation
Closed Fracture Reduction

Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries