An interventional study of Partial reduction with overriding position and Closed anatomic reduction in Bone Fractures, Radius Fractures and Closed Fractures, sponsored by Carlos A Acosta-Olivo. Completed. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by Carlos A Acosta-Olivo · Not applicable, Interventional, and Treatment
This fractures have been managed with anatomical reduction performed under anesthesia or using sedatives. In our institution this means prolonged hospital stay, involvement of an anesthesiologist and the use of an special room in the Emergency Department. This research protocol was born after reports were published regarding leaving the fractures in an overriding position and cast with good functional and acceptable radiographical results; said study was observational, providing valuable but limited information about this treatment option. On the other hand, our study is a randomized controlled trial between to groups of patients younger than 11 years old who presented to the Emergency Department with completely displaced distal radius fractures, they were randomly assigned to one of two groups, either a closed anatomic reduction and short cast or a closed overriding alignment and short cast.
Distal radius fractures represent up to 40% of all fractures in pediatric patients, with the most common mechanism being simple falls with the hand and wrist in extension. The standard treatment for this kind of fractures is a closed anatomical reduction and placing a short arm cast for 6 week, with a weekly follow-up paying close attention to re-displacement and consolidation data. This fractures have acceptable deformity angles after the anatomical reduction of up to 15º in the coronal and sagittal plane; in order to perform this reduction, the patient is subject to a sedation under strict monitorization, either in the Emergency Department or in the Surgical Room. In most cases, the patient must stay in the hospital for at least 3 hours after the procedure was performed, in order to be discharged with analgesics and appropriate indications for caring a cast in home.
Distal radius fractures in pediatric patients have been managed with anatomical reduction performed under anesthesia or using sedatives. In our institution this means prolonged hospital stay, involvement of an anesthesiologist and the use of aa special room in the Emergency Department. This research protocol was born after reports were published regarding leaving the fractures in an overriding position and cast with good functional and acceptable radiographical results; said study was observational, providing valuable but limited information about this treatment option. On the other hand, our study is a randomized controlled trial between to groups of patients younger than 11 years old who presented to the Emergency Department with completely displaced distal radius fractures, they were randomly assigned to one of two groups, either a closed anatomic reduction and short cast or a closed overriding alignment and short cast.
Recent studies have suggested an alternative option for this patients, in which instead of performing a complete reduction, a gentle maneuver is done in order to get partial alignment or overriding fracture, with an strict follow-up and cooperative patients, this method has shown good results in terms of consolidation and deformity angles. The new procedure is performed without anesthesia, instead non-steroid antiinflammatory and analgesics are given to the patient, giving the possibility of an early discharge.
The possibility of leaving the patient with an overriding position and having good results is related to recent studies about bone in pediatric patients, especially in those younger than 14 years old. The published observations presume that fracture consolidation and remodeling potential is given by physis presence and the persistence throughout the years. Even more importantly, it is now known that the distal radius is predominantly formed by trabecular bone and a thicker periosteum, conditions that confer this bone a higher consolidation rate and rapid remodeling, leaving permanent deformities and reinterventions as rather rare situations. In terms of aesthetic deformities, 20º of radiological deformity in any plane is required to leave a clinically visible deformity, and even more so, 35º are needed to cause a functional impairment.
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This study's enrollment of 58 is below the median of 80 across 458 interventional studies indexed under Fractures, Bone.
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Exclusion Criteria:
Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult. The intervention in this control group was performing a closed anatomic reduction under anesthesia.
Procedure: Closed anatomic reduction
Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult. The intervention in this control group was not performing a closed anatomic reduction under anesthesia.
Procedure: Partial reduction with overriding position
The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks.
The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks.
Radial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups.
The cast was removed afer 6 weeks and rehabilitation in house was started as soon as the pain was over. The simple X rays were evaluated with the Montoya Classification, which stratifies the patients with regards of time until radiographic consolidation and bone remodeling. The radial tilt, radial shortening and radial variation was recorded and compared with the control group. This radiologic measures were reported in terms of degrees and millimeters were needed.
Time frame: 10 weeks
Patients With Residual Radiographic Deformities Obtained in Both Groups.
The cast was removed afer 6 weeks and rehabilitation in house was started as soon as the pain was over. The simple X rays were evaluated with the Montoya Classification, which stratifies the patients with regards of time until radiographic consolidation and bone remodeling. The radial tilt, radial shortening and radial variation was recorded and compared with the control group. This radiologic measures were reported in terms of degrees and millimeters were needed.
Time frame: 10 weeks
Pain Assessed by the Visual Analogue Scale (VAS) in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction in Comparison to Those Treated With Anatomical Reduction.
The Visual Analogue Scale (VAS) was used in order to assess the residual pain in the experimental group, this is, in patients with distal radius fractures treated without an anatomical reduction, this was later compared to the results obtained in the group in which a reduction was performed. Minimum value 0 maximum value 10. Higher score means a worse outcome.
Time frame: 10 weeks
Residual Functional Deficits Assessed by the UEFI (Upper Extremity Functional Index)in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction.
Patients were evaluated using a modified Upper Extremity Functional Index (UEFI) scale fot the appropriate age in order to assess functional deficits in the fractured limb in patients with distal radius fractures treated without an anatomical reduction. Evaluates the impairment the subject perceives they encounter when performing 20 types of activities of daily living. Each of the 20 actions in the UEFI is evaluated on a 5-point scale. Minimum Value 0 maximum value 4 per action, where 0 indicates most severe limitation and 80 suggests least limitation.
Time frame: 10 weeks
Aesthetic Results Measured by Clinical Radial Alignment in Degrees in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction in Comparison to Those Treated With Anatomical Reduction in Both Groups.
Patients were evaluated in comparison to the other extremity in terms of clinically evident deformity and appearance. Varus, Valgus, antecurvatum and recurvatum was measured and recorded appropriately. This was later compared to the data obtained in those patients who were treated with an anatomic reduction.
Time frame: 10 weeks
The patients in this research study were those admitted to the Emergency department of the Hospital Universitario "José Eleuterio González" between July 1, 2014 and December 1, 2015 with a diagnosis of a acute completely displaced distal radius fractures who matched our inclusion criteria.
| Milestone | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position |
|---|---|---|
| Started | 29 | 29 |
| Completed | 29 | 29 |
| Not completed | 0 | 0 |
The cast was removed afer 6 weeks and rehabilitation in house was started as soon as the pain was over. The simple X rays were evaluated with the Montoya Classification, which stratifies the patients with regards of time until radiographic consolidation and bone remodeling. The radial tilt, radial shortening and radial variation was recorded and compared with the control group. This radiologic measures were reported in terms of degrees and millimeters were needed.
| degrees | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position |
|---|---|---|
| Radial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups. | 8.96 ± 1.2 | 8.998 ± 1.34 |
The Visual Analogue Scale (VAS) was used in order to assess the residual pain in the experimental group, this is, in patients with distal radius fractures treated without an anatomical reduction, this was later compared to the results obtained in the group in which a reduction was performed. Minimum value 0 maximum value 10. Higher score means a worse outcome.
| units on a scale | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position |
|---|---|---|
| Pain Assessed by the Visual Analogue Scale (VAS) in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction in Comparison to Those Treated With Anatomical Reduction. | 3.4 ± 0.8 | 1.2 ± 0.7 |
Patients were evaluated using a modified Upper Extremity Functional Index (UEFI) scale fot the appropriate age in order to assess functional deficits in the fractured limb in patients with distal radius fractures treated without an anatomical reduction. Evaluates the impairment the subject perceives they encounter when performing 20 types of activities of daily living. Each of the 20 actions in the UEFI is evaluated on a 5-point scale. Minimum Value 0 maximum value 4 per action, where 0 indicates most severe limitation and 80 suggests least limitation.
| units on a scale | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position |
|---|---|---|
| Residual Functional Deficits Assessed by the UEFI (Upper Extremity Functional Index)in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction. | 1.78 ± 0.062 | 0.755 ± 0.059 |
Patients were evaluated in comparison to the other extremity in terms of clinically evident deformity and appearance. Varus, Valgus, antecurvatum and recurvatum was measured and recorded appropriately. This was later compared to the data obtained in those patients who were treated with an anatomic reduction.
| degrees | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position |
|---|---|---|
| Radius valgus | 2.5 ± 0.8 | 2.1 ± 0.7 |
| Radius Varus | 2.1 ± 0.3 | 3.1 ± 0.5 |
| Final Ulnar tilt | 1.2 ± 0.08 | 2.5 ± 1.2 |
The cast was removed afer 6 weeks and rehabilitation in house was started as soon as the pain was over. The simple X rays were evaluated with the Montoya Classification, which stratifies the patients with regards of time until radiographic consolidation and bone remodeling. The radial tilt, radial shortening and radial variation was recorded and compared with the control group. This radiologic measures were reported in terms of degrees and millimeters were needed.
| participants | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position |
|---|---|---|
| Patients With Residual Radiographic Deformities Obtained in Both Groups. | 4 | 1 |
Collected over The adverse event data was collected for 3 years.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anatomic Closed Reduction + Short Cast | — | 2/29 (6.9%) | 2/29 (6.9%) |
| Partial Reduction Overriding Position | — | 0/29 (0%) | 0/29 (0%) |
| Event | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position |
|---|---|---|
| Fracture redisplacement after reduction and castMusculoskeletal and connective tissue disorders | 2/29 | 0/29 |
| Event | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position |
|---|---|---|
| PainMusculoskeletal and connective tissue disorders | 1/29 | 0/29 |
| Delayed Fracture HealingMusculoskeletal and connective tissue disorders | 1/29 | 0/29 |
We included 29 patients in both arms. All of the patients included in this trial completed the according follow-up.
| Age, Continuous(years) | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position | Total |
|---|---|---|---|
| Mean | 8.10 ± 2.05 | 8.59 ± 2.10 | 8.34 ± 2.10 |
| Sex: Female, Male(Participants) | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position | Total |
|---|---|---|---|
| Female | 4 | 11 | 15 |
| Male | 25 | 18 | 43 |
| Ethnicity (NIH/OMB)(Participants) | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position | Total |
|---|---|---|---|
| Hispanic or Latino | 29 | 29 | 58 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Anatomic Closed Reduction + Short Cast | Partial Reduction Overriding Position | Total |
|---|---|---|---|
| Mexico | 29 | 29 | 58 |
No study locations are listed for this record.
The record gives a start of Jan 2013, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2019, 3 years 11 months after primary completion.
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Carlos A Acosta-Olivo