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| Name | Class |
|---|---|
| Helse-Bergen HF | OTHER |
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The purpose of this study is to evaluate function, pain and radiographic evaluation in patients treated with volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular distal radius fractures, AO/OTA type A
We have designed a randomized prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular dislocated distal radius fractures AO/OTA type A3. On the basis of power analysis a total of 160 patients are to be included in this project. The follow-up period is 1 year and evaluation is based on x-ray analysis, grip strength, range of motion, pain and satisfaction with the treatment ( PRWE, Quick-DASH)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volar locked plating | Active Comparator | One group with distal radius fracture is operated with Locking plate |
|
| Hoffman external fixator | Active Comparator | One group with distal radius fracture is operated with Hoffman external fixator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volar locked plating | Device | Operative treatment of distal radius fracture with volar locking plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient rated wrist evaluation (PRWE)score | 3 months | |
| Patient rated wrist evaluation (PRWE)score | 6 weeks | |
| Patient rated wrist evaluation (PRWE)score | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quick-DASH score | 6 weeks, 3 and 12 months | |
| Pain VAS-score | 6 weeks, 3 and 12 months | |
| Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trine Ludvigsen, Md | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic depatment, Voss hospital | Bergen | Voss | 5700 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23298757 | Background | Esposito J, Schemitsch EH, Saccone M, Sternheim A, Kuzyk PR. External fixation versus open reduction with plate fixation for distal radius fractures: a meta-analysis of randomised controlled trials. Injury. 2013 Apr;44(4):409-16. doi: 10.1016/j.injury.2012.12.003. Epub 2013 Jan 6. | |
| 34746674 | Derived | Ludvigsen T, Matre K, Vetti N, Kristoffersen PM, Toppe MK, Gudmundsdottir R, Krukhaug Y, Dybvik E, Fevang JM. Is there a correlation between functional results and radiographic findings in patients with distal radius fracture A0 type A3 treated with volar locking plate or external fixator? OTA Int. 2021 Aug 9;4(3):e142. doi: 10.1097/OI9.0000000000000142. eCollection 2021 Sep. |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Hoffman external fixator | Device | Patients with distal radius fracture operated with Hoffman external fixator |
|
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Number of patients with per- and postoperative complications will be registrated. Types of expected complications: Tendon rupture, Tendon irritation, Carpal Tunnel Syndrome, Complex Regional Pain Syndrome, Screw displacement/screw loosening, Delayed fracture union
| 6 weeks, 3 and 12 months |
| Radiographic evaluation | Palmar tilt, Radial inclination, Ulnar variance, Fracture union | 6 weeks and 12 months |