Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radio-radial fixator | Experimental | Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes) |
|
| Percutaneous pinning | Active Comparator | Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radio-radial fixator | Procedure | Using the Distal Radius Fixator from Synthes. A single splint for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Grip Strength | Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département d'orthopédie, CHA-Pavillon Enfant-Jésus | Québec | Quebec | G1J1Z4 | Canada |
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.
Recruitment started in April of 2003 and finished in June of 2006.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Radio-radial Fixator | Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes) |
| FG001 | Percutaneous Pinning | Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Radio-radial Fixator | Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes) |
| BG001 | Percutaneous Pinning | Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No participant changed to the other group. Patients lost or with complications were not analyzed | Posted | Mean | 95% Confidence Interval | Percentage of opposite side | 6 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radio-radial Fixator | Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes) |
Not provided
Not provided
Very long time between the end of the study and the manuscript preparation due to temporarily lack of statistician and the need for some national associations that the study is not published before presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Stéphane Pelet, MD, PhD | Département d'orthopédie, CHA-Pavillon Enfant-Jésus Québec | 418-649-0252 | 3165 | stephane.pelet.ortho@gmail.com |
Not provided
| ID | Term |
|---|---|
| D011885 | Radius Fractures |
| ID | Term |
|---|---|
| D005543 | Forearm Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percutaneous pinning | Procedure | Insert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks. |
|
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Percentage of opposite side | 6 months |
|
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Percutaneous Pinning | Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks | 0 | 63 | 0 | 63 |
Not provided
Not provided
| Pronation |
|
| Supination |
|
| Radial inclination |
|
| Cubital inclination |
|