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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| Department of Orthopedics, Motala | UNKNOWN |
| Department of Orthopedics, Norrköping | UNKNOWN |
| Department of Orthopedics, Nykoeping |
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A prospective randomized study comparing a new implant with three interlocked pins for internal fixation of femoral neck fractures (Hansson Pinloc System, Swemac Linköping, Sweden) versus 2 parallel pins with hooks (Hansson Pins, Swemac Linköping, Sweden).
Patients, who are to be treated with internal fixation due to a femoral neck fracture, will be randomized by the surgeon to Pinloc or Hansson Pins using an on-line randomization system.
The patients will be followed up at open visits at 3 months and 1 year. At two years the patients will be contacted by phone and medical records studied in order to detect any fracture complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pinloc | Experimental | Plate and 3 interlocked pins. A new device for fixation of femoral neck fractures. |
|
| LIH (Hansson pins) | Active Comparator | 2 pins. An established method for fixation of femoral neck fractures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pinloc | Device | Internal fixation device |
| |
| Hansson Pins (LIH) |
| Measure | Description | Time Frame |
|---|---|---|
| Failure of fracture treatment | Failure is defined as non-union or avascular necrosis. | Within 2 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Timed-up and go test | Stand up, walk 3 meters, turn around and sit down | At 3 months and 1 year postoperatively |
| WOMAC (An established hip score) | An established hip score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torsten Johansson, MD,Ass prof | Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden. | Principal Investigator |
| Torsten Johansson, MD,Ass prof | Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedics | Eskilstuna | 631 88 | Sweden | |||
| Department of Orthopedics |
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| UNKNOWN |
| Department of Orthopedics, Eskilstuna | UNKNOWN |
| Department of Orthopedics, Falun | UNKNOWN |
| Uppsala University Hospital | OTHER |
| Department of Orthopedics, Helsingborg | UNKNOWN |
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| Device |
Internal fixation device |
|
| At 3 months and 1 year postoperatively |
| Quality of life (EQ-5D) | EQ-5D | At 3 months and 1 year postoperatively |
| Pain (Visual analogue scale) | Visual analogue scale (VAS): At rest and during activity | At 3 months and 1 year postoperatively |
| Falun |
| 791 82 |
| Sweden |
| Department of Orthopaedics | Gothenburg | 413 45 | Sweden |
| Department of Orthopedics | Helsingborg | 251 87 | Sweden |
| Department of Orthopedics, Aleris | Motala | 591 85 | Sweden |
| Department of Orthopedics | Norrköping | 601 82 | Sweden |
| Department of Orthopedics | Nyköping | 611 88 | Sweden |
| Department of Orthopedics | Uppsala | 751 85 | Sweden |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |