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.
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
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).
- Conditions
- Radius Fracture Distal
- 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 group | Role | What they receive |
|---|---|---|
| 3 week percutaneous pinning group | Experimental | Percutaneous pinning time will be for three weeks and short cast immobilization for six weeks. Receives: Procedure: Percutaneous pinning time |
| 6 week percutaneous pinning group | Active comparator | Percutaneous 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.
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)
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
Wrist mobility
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer.
Measured: 14 weeks
Grip strength
Using a hydraulic dynamometer with the patient's elbow in 90 grades of flexion and forearm in neutral rotation.
Measured: 14 weeks
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.
- First posted17 Oct 2017
- Study start29 Sep 2017
- Primary completion20 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Radius Fracture DistalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Carlos A Acosta-Olivo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon
- Investigators
- Carlos Acosta-Olivo, PhD, Principal investigator, Universidad Autonoma de Nuevo Leon
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 25143645Niver 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 23026468Dhainaut 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 25030810Henn 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 24651288Turner 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 17560404Davis 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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Radius Fracture: Comparison Between Three and Six Weeks of Percutaneous Fixation
- ClinicalTrials.gov ID
- NCT03311633
- Acronym / sponsor ID
- OR17-00011
- Conditions
- Radius Fracture Distal
- Keywords
- Radius Fracture Distal, Radius Fracture Distal Therapy, Fracture fixation, Closed Fracture Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Carlos A Acosta-OlivoUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Three week percutaneous pinning group versus Six week percutaneous pinning group
| Arm | Type | Receives |
|---|---|---|
| 3 week percutaneous pinning group | Experimental | Procedure: Percutaneous pinning timePercutaneous pinning time will be for three weeks and short cast immobilization for six weeks. |
| 6 week percutaneous pinning group | Active comparator | Procedure: Percutaneous pinning timePercutaneous pinning time will be for six weeks and also short cast immobilization. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous pinning timePercutaneous pinning time will be compared in two groups: 3 versus 6 weeks. | Procedure or surgery | 3 week percutaneous pinning group, 6 week percutaneous pinning group |
Primary outcome
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
4 secondary outcomes
Patient Rated Wrist Evaluation (PRWE)
Time frame: 14 weeks
Wrist mobility
Time frame: 14 weeks
Grip strength
Time frame: 14 weeks
Skin condition
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Results publication: PubMed 25143645Tahririan 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.
- Results publication: PubMed 23026468Niver 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.
- Results publication: PubMed 25030810Dhainaut 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.
- Results publication: PubMed 24651288Henn 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.
- Results publication: PubMed 17560404Turner 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.
- Results publication: PubMed 20494749Davis 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.
- Individual participant dataSharing planned: Undecided. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Acosta-Olivo, PhD principal investigator
Universidad Autonoma de Nuevo Leon
2 sites in 1 country: see every site and its status.
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.