An interventional study of Percutaneous pinning time in Radius Fracture Distal, sponsored by Carlos A Acosta-Olivo. Completed at 2 sites in Mexico. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Carlos A Acosta-Olivo · Not applicable, Interventional, and Treatment
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.
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).
330 studies on the registry are indexed under Wrist Fractures; 73 are open to participants now.
This study's enrollment of 60 is close to the median of 62 across 265 interventional studies indexed under Wrist Fractures.
Browse Wrist Fractures studies →Carlos A Acosta-Olivo is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Percutaneous pinning time will be for three weeks and short cast immobilization for six weeks.
Procedure: Percutaneous pinning time
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.
Visual Analogue Scale
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
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
Time frame: 14 weeks
Wrist mobility
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer.
Time frame: 14 weeks
Grip strength
Using a hydraulic dynamometer with the patient's elbow in 90 grades of flexion and forearm in neutral rotation.
Time frame: 14 weeks
Skin condition
Evaluation of skin condition and integrity, when normal is equal to 0, ulcer=1 and granuloma=2
Time frame: 6 weeks
Plan to share: Undecided — Not yet decided
Ran from Sep 2017 to primary completion in Apr 2024, 78 months.
Of 125 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's 78 months is above that.
Counting every sponsor, half of 126 studies reached it within 26 months; a quarter within 16 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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