Direct Anterior Approach for Femoral Neck Fractures

Study Overview
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Brief Summary
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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.

Detailed Description
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first included patient 23th November 2018

Official Title
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A Randomized Controlled Trial Comparing Direct Anterior Approach to Direct Lateral Approach in Patients Receiving a Total Hip Arthroplasty for Femoral Neck Fracture - a 1 Year Follow-up Study

Conditions
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Femoral Neck Fractures

Intervention / Treatment
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* Procedure: Direct anterior approach
* Procedure: Direct Lateral Approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dislocated femoral neck fracture Exclusion Criteria: Infection around the hip (soft tissue or bone) Pathologic fracture Excessive alcohol or substance abuse that most likely will give reduced compliance Patients with any fractures of the long bones in the lower extremity, fracture of the spine, and/or intra-thoracic or intra-abdominal injury (i.e., multiple trauma). Because the outcomes and clinical course of patients with multiple trauma may be quite different from a non-trauma patient. Bedridden patients/non-walkers

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct anterior approach<br>total hip arthroplasty with direct anterior approach | Procedure: Direct anterior approach<br>* total hip arthroplasty with DAA<br>* Other names: DAA;|
| Experimental: Direct Lateral Approach<br>total hip arthroplasty with direct lateral approach | Procedure: Direct Lateral Approach<br>* total hip arthroplasty with DLA<br>* Other names: DLA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Time Up and Go Test (TUG) |  | 2,6,12 weeks, and 1 year | 
| Change in Forgotten Joint Score for hip (FJS-12) | 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. | 2,6,12 weeks, and 1 year | 
| Change in Oxford Hip Score (OHS) | 12 questions. Every question is scored 4 to 0 according to the selected response. Thus it is a continuous score ranging from 48-0. Each of the 12 questions on the Oxford hip score is scored in the same way with the score decreasing as the reported symptoms increase (ie. become worse). All questions are laid out similarly with response categories denoting least (or no) symptoms being to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0). | 2,6,12 weeks, and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EQ-5D-5L score | 5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233' We then convert this specific health state to an index value specific for that country. The index value calculator can be downloaded from the EuroQol Office | 2,6,12 weeks, and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Replacement, Hip, Orthopedic procedures