Radius Fractures
Conditions
Keywords
Radius fractures, Radio-radial fixator, Percutaneous pinning, Grip strength
Brief summary
The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function. The purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.
Interventions
PROCEDURERadio-radial fixator
Using the Distal Radius Fixator from Synthes. A single splint for 5 days.
PROCEDUREPercutaneous pinning
Insert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks.
Sponsors
Hopital de l'Enfant-Jesus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Distal radius fracture Frykman I or II * Unstable fracture according to Lafontaine's criteria * Fracture line more than 1cm form the joint line * Closed fracture * Age \> 18 years * Surgery performed between 72 hours from the trauma * Monotrauma * Patient signed the informed consent
Exclusion criteria
* Distal radius fracture Frykman III-VI (intra-articular fracture) * Open fracture * Polytraumatism * Stable or non-displaced fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Grip Strength | 6 months | Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of Movement of Wrist | 6 months | Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination. Motion is described as a percentage of the opposite side. |
Countries
Canada
Participant flow
Recruitment details
Recruitment started in April of 2003 and finished in June of 2006.
Pre-assignment details
Only surgical fractures were addressed to the research team, after prior selection by orthopedic surgeon. So we didn't see all radius fractures in the department.
Participants by arm
| Arm | Count |
|---|---|
| Radio-radial Fixator Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes) | 57 |
| Percutaneous Pinning Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks | 63 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | algodystrophy | 2 | 2 |
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Percutaneous Pinning | Radio-radial Fixator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 46 Participants | 97 Participants |
| Age Continuous | 54 years STANDARD_DEVIATION 16 | 57 years STANDARD_DEVIATION 19 | 55.6 years STANDARD_DEVIATION 18 |
| Region of Enrollment Canada | 63 participants | 57 participants | 120 participants |
| Sex: Female, Male Female | 44 Participants | 40 Participants | 84 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 63 |
| serious Total, serious adverse events | 0 / 57 | 0 / 63 |
Outcome results
Primary
The Grip Strength
Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.
Time frame: 6 months
Population: No participant changed to the other group. Patients lost or with complications were not analyzed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Radio-radial Fixator | The Grip Strength | 98.3 Percentage of opposite side |
| Percutaneous Pinning | The Grip Strength | 62.6 Percentage of opposite side |
Comparison: We assess that 15% is a significative strength difference. According to a 80% study power, a SD at 25% and a 20% lost to follow-up, we found 118 patients for the all study.p-value: <0.05Chi-squared
Secondary
Range of Movement of Wrist
Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination. Motion is described as a percentage of the opposite side.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Radio-radial Fixator | Range of Movement of Wrist | Dorsal flexion | 93.8 Percentage of opposite side |
| Radio-radial Fixator | Range of Movement of Wrist | Volar flexion | 93.5 Percentage of opposite side |
| Radio-radial Fixator | Range of Movement of Wrist | Pronation | 98 Percentage of opposite side |
| Radio-radial Fixator | Range of Movement of Wrist | Supination | 90 Percentage of opposite side |
| Radio-radial Fixator | Range of Movement of Wrist | Radial inclination | 90.7 Percentage of opposite side |
| Radio-radial Fixator | Range of Movement of Wrist | Cubital inclination | 94 Percentage of opposite side |
| Percutaneous Pinning | Range of Movement of Wrist | Radial inclination | 71.1 Percentage of opposite side |
| Percutaneous Pinning | Range of Movement of Wrist | Dorsal flexion | 81.7 Percentage of opposite side |
| Percutaneous Pinning | Range of Movement of Wrist | Supination | 80 Percentage of opposite side |
| Percutaneous Pinning | Range of Movement of Wrist | Volar flexion | 74.7 Percentage of opposite side |
| Percutaneous Pinning | Range of Movement of Wrist | Cubital inclination | 65.6 Percentage of opposite side |
| Percutaneous Pinning | Range of Movement of Wrist | Pronation | 90 Percentage of opposite side |
p-value: <0.0595% CI: [80, 100]Chi-squared