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
Not provided
Not provided
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 NCT 01034943 and a new permit has been issued by the Swedish National board on Ethical Permits
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| external fixation | Active Comparator | Operation with external fixation and optional addition of k-wire |
|
| Volar plate | Experimental | Operation with a Synthes volar two column plate (TCP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External fixation | Procedure | Bridging external fixation of a distal radius fracture with an optional addition of k-wire(s) |
|
| 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 is the degree of malalignment on the x-ray of the injured wrist. | 12 months | |
| A secondary outcome of this study is the EQ5D, which is a validated quality-of-life instrument. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stockholm South Hospital Department of Orthopeadic Surgery | Stockholm | Stockholm County | 11883 | Sweden |
Not provided
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D016267 | External Fixators |
| ID | Term |
|---|---|
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Volar plate | Procedure | Operation of distal radius fracture with open reduction and fixation with a plate from the volar side of the wrist. |
|
|
| D053831 | Surgical Fixation Devices |