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| Name | Class |
|---|---|
| Sophies Minde Ortopedi | INDUSTRY |
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120 patients age 18-64 years with dorsally displaced distal radius fractures AO-type A2, A3 and C1 are recruited from Oslo Casualty Medical Centre (Oslo Skadelegevakt). Patients are randomized to surgery with closed reduction and pins (CRPP) or open reduction and volar locking plate (VLP). The hypotheses is that CRPP will give equal function and satisfaction to VLP. Patients are followed by current practice of follow-ups until 5 weeks postoperatively, and in addition due to the study with functional tests after 2, 3, 6 and 12 months. These follow-ups will be performed by hand therapist. Scores are also recorded from Patient-Reported Wrist and Hand Evaluation (PRWHE), Quick-Dash (Q-d) and EuroQol Questionnaire (EQ-5D) questionnaires. The main efficacy measure in the study is PRWHE scores after 12 months. There will be X-ray initially, postoperatively and after 12 months. Sub-objectives in the study are analyses of cost-effectiveness (measured by EQ 5D, personnel use, use of additional healthcare service and absence from work), and differences in complications between the two methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VLP | Active Comparator | Open reduction and volar locking plate |
|
| CRPP | Active Comparator | Closed reduction and percutaenous K-wires/pins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open reduction and volar locking plate and closed reduction and K-wires. | Procedure | DVR Anatomic Plate, K-wires |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Related Wrist and Hand Evaluation (PRWHE) score | PROM of 15 questions, score ranging from 0 (best) to 100 (worst) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Dash score | PROM of 11 questions, score ranging from 0 (best) to 100 (worst) | 1 year |
| X-ray wrist posterior-anterior and lateral view | Volar tilt (degrees), radial inclination (degrees), ulnar variance (mm), stepp-off (mm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Williksen, MD | Oslo University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skadelegevakten | Oslo | 0182 | Norway |
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| 1 year |
| Range of motion | Flexion, extension, supination and pronation measured in degrees from neutral position, pulpa palm distance in cm | 1 year |
| Grip strength | Grip strength with a hand dynamometer | 1 year |
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D003100 | Colles' Fracture |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D000072039 | Fracture Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D011885 | Radius Fractures |
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| ID | Term |
|---|---|
| D000070799 | Open Fracture Reduction |
| D001864 | Bone Wires |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |
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