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Radius Fracture DistalNCT03311633

Complications in Distal Radius Fracture

A study testing Percutaneous pinning time in people with Radius Fracture Distal, run by Carlos A Acosta-Olivo at 2 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Radius Fracture Distal
What is being tested?
Percutaneous pinning time
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesMexico
Study dates
29 Sep 2017to 23 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites
  • Universidad Autonoma de Nuevo Leon

    Monterrey, Nuevo León, 64480

  • Universidad Autonoma de Nuevo Leon

    Monterrey, Nuevo León, 66460

Other trials in Mexico

About this study

Official title: Distal Radius Fracture: Comparison Between Three and Six Weeks of Percutaneous Fixation

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).

Being tested
Percutaneous pinning time
Keywords
Radius Fracture Distal, Radius Fracture Distal Therapy, Fracture fixation, Closed Fracture Reduction
Medical subject headings
Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous pinning timeProcedure or surgery

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

Study groups in NCT03311633
Study groupRoleWhat they receive
3 week percutaneous pinning groupExperimentalPercutaneous pinning time will be for three weeks and short cast immobilization for six weeks.
Receives: Procedure: Percutaneous pinning time
6 week percutaneous pinning groupActive comparatorPercutaneous pinning time will be for six weeks and also short cast immobilization.
Receives: Procedure: Percutaneous pinning time

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 14 week

Secondary outcomes (4)
  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

    Measured: 14 weeks

  2. Wrist mobility

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

    Measured: 14 weeks

  3. Grip strength

    Using a hydraulic dynamometer with the patient's elbow in 90 grades of flexion and forearm in neutral rotation.

    Measured: 14 weeks

  4. Skin condition

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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2017
  2. Study start29 Sep 2017
  3. Primary completion20 Apr 2024
  4. Study completion23 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three week percutaneous pinning group versus Six week percutaneous pinning group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03311633
Sponsor's protocol ID
OR17-00011
Status last verified
May 2024
First submitted
11 Oct 2017
Last updated
8 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Not yet decided

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

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous pinning time in people with Radius Fracture Distal, run by Carlos A Acosta-Olivo at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (time frame: 14 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03311633, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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