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CompletedNCT03311633Updated May 8, 2024

Complications in Distal Radius Fracture

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

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Radius Fracture Distal

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Keywords

  • Radius Fracture Distal
  • Radius Fracture Distal Therapy
  • Fracture fixation
  • Closed Fracture Reduction
03

In context

Wrist Fractures

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 →

Lead sponsor

Carlos A Acosta-Olivo is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 signature

Exclusion criteria

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
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

  • Active comparator
    6 week percutaneous pinning group

    Percutaneous pinning time will be for six weeks and also short cast immobilization.

    Procedure: Percutaneous pinning time

Interventions

  • ProcedurePercutaneous pinning time

    Percutaneous pinning time will be compared in two groups: 3 versus 6 weeks.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Wrist mobility

    Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer.

    Time frame: 14 weeks

  3. 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

  4. Skin condition

    Evaluation of skin condition and integrity, when normal is equal to 0, ulcer=1 and granuloma=2

    Time frame: 6 weeks

07

Study locations

2 sites
  • Universidad Autonoma de Nuevo Leon
    Monterrey, Nuevo Leon 64480, Mexico
  • Universidad Autonoma de Nuevo Leon
    Monterrey, Nuevo Leon 66460, Mexico
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References and documents

Publications

  • 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. PubMed 25143645 ↗
  • 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. PubMed 23026468 ↗
  • 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. PubMed 25030810 ↗
  • 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. PubMed 24651288 ↗
  • 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. PubMed 17560404 ↗
  • 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. PubMed 20494749 ↗

Individual participant data

Plan to share: Undecided — Not yet decided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Oct 11, 2017
First posted
Oct 17, 2017
StartActual
Sep 29, 2017
Primary completionActual
Apr 20, 2024
CompletionActual
Apr 23, 2024
Last update
May 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03311633
Lead sponsor
Carlos A Acosta-Olivo
Responsible party
Carlos A Acosta-Olivo (Principal Investigator, Universidad Autonoma de Nuevo Leon) — Sponsor-investigator
First posted
Oct 17, 2017
Start date
Sep 29, 2017
Primary completion
Apr 20, 2024
Completion
Apr 23, 2024
Last update
May 8, 2024

Study contacts

Carlos Acosta-Olivo, PhD
principal investigator · Universidad Autonoma de Nuevo Leon

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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