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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 : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

Tracking Information
First Submitted Date  ICMJE October 11, 2017
First Posted Date  ICMJE October 17, 2017
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE September 29, 2017
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
Skin condition [ Time Frame: 6 week ]
Skin integrity will be evaluated (normal, ulcer or granuloma)
Change History Complete list of historical versions of study NCT03311633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • 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
  • Wrist mobility [ Time Frame: 14 weeks ]
    Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer.
  • 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.
  • Skin condition [ Time Frame: 6 weeks ]
    Evaluation of skin condition and integrity, when normal is equal to 0, ulcer=1 and granuloma=2
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
  • Pain scale [ Time Frame: 14 week ]
    Visual Analogue Scale (VAS) minimum 0 value= no pain; maximum 10 value= unsupportable pain
  • 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
  • Wrist mobility [ Time Frame: 14 weeks ]
    Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Complications in Distal Radius Fracture
Official Title  ICMJE Distal Radius Fracture: Comparison Between Three and Six Weeks of Percutaneous Fixation
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Radius Fracture Distal
Intervention  ICMJE Procedure: Percutaneous pinning time
Percutaneous pinning time will be compared in two groups: 3 versus 6 weeks.
Study Arms  ICMJE
  • Experimental: 3 week percutaneous pinning group
    Percutaneous pinning time will be for three weeks and short cast immobilization for six weeks.
    Intervention: Procedure: Percutaneous pinning time
  • Active Comparator: 6 week percutaneous pinning group
    Percutaneous pinning time will be for six weeks and also short cast immobilization.
    Intervention: Procedure: Percutaneous pinning time
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Carlos Acosta-Olivo, PhD +518183476698 dr.carlosacosta@gmail.com
Contact: Yadira Tamez-Mata, MD +518183476698 dra.yadiratamez@gmail.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03311633
Other Study ID Numbers  ICMJE OR17-00011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Not yet decided
Responsible Party Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon
Study Sponsor  ICMJE Carlos A Acosta-Olivo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carlos Acosta-Olivo, PhD Universidad Autonoma de Nuevo Leon
PRS Account Universidad Autonoma de Nuevo Leon
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP