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Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.
This study has been merged with study NCT01035359 and a new ethical permission has been granted by the Swedish National Ethic board
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| External fixation | Active Comparator | Operation with external fixation and optional addition of k-wire |
|
| Volar plate | Active Comparator | Operation with Synthes volar two column plate (TCP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External fixation | Procedure | Operation with external fixation and optional addition of k-wire |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist. | 12 months | |
| A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sari Ponzer, Professor | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stockholm South Hospital Department of Orthopeadic Surgery | Stockholm | Stockholm County | 118 83 | Sweden |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D016267 | External Fixators |
| ID | Term |
|---|---|
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Volar plate | Procedure | Operation with a Synthes volar two column plate (TCP) |
|
|
| D053831 | Surgical Fixation Devices |