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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Kristiansund Hospital | OTHER |
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The primary objective is to examine if in patients with a dislocated femoral neck fracture who receive a total hip arthroplasty, direct anterior approach will give a better result in terms of mobilization, function and pain in the first weeks and months postoperatively, than direct lateral approach.
first included patient 23th November 2018
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct anterior approach | Experimental | total hip arthroplasty with direct anterior approach |
|
| Direct Lateral Approach | Experimental | total hip arthroplasty with direct lateral approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct anterior approach | Procedure | total hip arthroplasty with DAA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Timed Up and Go Test (TUG) between the groups | It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. | 6 weeks postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Forgotten Joint Score for hip (FJS-12) between the groups | 12 questions. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48*100) For the final 'Forgotten Joint Score -12' a high score indicates good outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CK (Creatine Kinase) | Measure CK preoperatively and the first 4 postoperative days. | preoperatively and day 1,2,3,4 postoperatively. |
| Change in CRP (C-Reactive Protein) | Measure CRP preoperatively and the first 4 postoperative days. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Øystein B Lian, md phd | Helse Møre og Romsdal Hospital Trust (HF), Kristiansund Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kristiansund Hospital | Kristiansund | Norway |
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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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| Direct Lateral Approach | Procedure | total hip arthroplasty with DLA |
|
|
| 2,6,12 weeks, and 1 year |
| Difference in EQ-5D-5L score between the groups | 5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233'. As there is no Norwegian index, the EQ5D-5L was converted into a Swedish index score. | 2,6,12 weeks, and 1 year |
| Difference in Oxford Hip Score (OHS) between the groups | 12 questions. Every question is scored 4 to 0 according to the selected response. Thus the highest score on 48 means a perfectly functioning hip, while a score on 0 means the worst outcome. | 2,6,12 weeks, and 1 year |
| Difference in Timed Up and Go Test (TUG) between the groups | It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down | 2,12 weeks, 1 year. |
| Difference in EQ5D-VAS between the groups | Respondents report their perceived health status with a grade ranging from 0 (worst possible health status) to 100 (best possible health status). | 2,6,12 weeks, and 1 year |
| radiological results 1. | We will look at the offset of the hip prosthesis. | postoperative, 3,12 months. |
| radiological results 2. | We will look at alignment of the stem. Femoral component angulation between 3° varus and 3° valgus relative to the femoral shaft axis will be considered neutral. Positioning outside this references will be graded as varus or valgus | postoperative, 3,12 months. |
| radiological results 3. | We will look at quality of stem cementation by Barrack | postoperative, 3,12 months. |
| radiological results 4. | We will look at leg length. It will be measured using the vertical height from the interteardrop line. | postoperative, 3,12 months. |
| radiological results 5. | We will look at inclination of the cup.It will be measured in reference to the interteardrop line. | postoperative, 3,12 months. |
| radiological results 6. | We will look at anteversion of the cup. It will be measured using the ischiolateral method. | postoperative, 3,12 months. |
| complications | periprosthetic fractures, dislocation, implant failure, neurovascular injury, infection. abductor failure, neurapraxia of LFCN), and mortality | Within the first year postoperatively. |
| preoperatively and day 1,2,3,4 postoperatively. |
| Change in Hb (Hemoglobin)-levels. | Measure Hb preoperatively and the first 4 postoperative days. | preoperatively and day 1,2,3,4 postoperatively. |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |