Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures

Study Overview
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Brief Summary
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The aim of the study is to test the hypothesis that patients older than 60 years with a femoral neck fracture eligible for hemi-arthroplasty (HA) operated by an anterior minimal-invasive approach as compared to a standard lateral Hardinge approach show better functional recovery postoperatively as measured by the Timed up and go-test (TUG).

Detailed Description
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HA via various well established approaches is the typical treatment for displaced femoral neck fractures in elderly patients. In the last decade, so called minimal-invasive surgery (MIS) for the implantation of total hip arthroplasty (THA) has become popular and studies have demonstrated that MIS is as safe as conventional approaches. Our hypothesis is that femoral neck fracture patients may especially benefit from MIS. To date, no published data exist comparing a Hueter minimal-invasive anterior (AMIS) with a conventional trans-gluteal Hardinge approach (CLAS) for HA. Geriatric patients presenting at the University hospital Basel (UHBS) with a femoral neck fracture eligible for HA are randomly assigned to the minimal-invasive or conventional group. In both groups HA will be performed using the same implants. Postoperatively patients will be followed-up continuously until discharge from our hospital (with 7 days as expected average duration of postoperative hospital stay) with a first functional status assessment on day 5. Further follow-up is planned at week 3 and 6, 3 months and one year postoperatively.

Official Title
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Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures - A Prospective Randomized Trial

Conditions
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Femoral Neck Fracture

Intervention / Treatment
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* Procedure: Trans-gluteal approach, CLAS
* Procedure: Anterior minimal invasive approach, AMIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 60 years or more, ambulatory with/without walking aids before trauma Femoral neck fracture eligible for hemi-arthroplasty in accordance with the algorithm for femoral neck fracture patients used at the University hospital Basel Informed consent Exclusion Criteria: Refusal of consent by the patient or legal representatives to participate in the study More than one fracture Suspicion of a pathological fracture in the context of known or unknown malignancy Previous surgery of the proximal femur on the same side Follow-up not possible (Tourist etc.)

Ages Eligible for Study
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Minimum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anterior minimal invasive approach, AMIS<br>AMIS in 95 randomized patients. | Procedure: Anterior minimal invasive approach, AMIS<br>* Minimal invasive Hueter anterior approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures<br>* Other names: Medacta, Mathys, Switzerland;|
| Active Comparator: Trans-gluteal approach, CLAS<br>CLAS in 95 randomized patients. | Procedure: Trans-gluteal approach, CLAS<br>* Classic lateral, trans-gluteal approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures<br>* Other names: Mecacta, Mathys, Switzerland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed up and go test (TUG) | TUG: Time in seconds a person needs to stand up from a chair, walk a distance of 3 meters, turn around a flag, come back and sit down again (with or without walking aids). | 3 weeks postoperatively +/- 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence measure (FIM) | FIM is a widely used method of assessing quality of daily life and the amount of assistance required for a person with a disability to perform basic activities safely and effectively. It includes 18 items focusing on a minimum set of skills related to self-care, sphincter control, transfers, locomotion, communication, and social cognition. Possible scores range from 18 to 126. | preoperative (retrospective assessment), day 5 postoperatively, 3 and 6 weeks postoperatively, 3 months and 1 year postoperatively (apart from measurement on day 5 postoperative each +/- 3 days ) | 
| Postoperative complications | Postoperative complications (proximal femoral fracture, nerve palsy, postoperative surgical site infection, aseptic loosening, peri-prosthetic fracture, re-operation, non-surgical complications etc.) as a secondary outcome variable will be continuously recorded using the Clavien-Dindo classification of surgical complications | duration from surgery until 1 year postoperatively | 
| Peri-operative delirium | To assess delirium, patients will be screened 3 times a day by the responsible nurse using a modified Delirium Observation Screening scale (DOS). DOS is a 13-item scale for early recognition of delirium. If DOS results in equal or more than 3 points, the Confusion Assessment Method (CAM) will be additionally applied. The CAM instrument consists of 4 respectively 5 operationalized criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). | duration from admission to day 3, an expected average period of 3-5 days | 
| One year mortality |  | one year | 
| Length of hospitalization |  | duration of the hospital stay, an expected average of 10 days | 
| Subgroup effect of patients with normal Mental-state Questionnaire (MSQ) versus patients with abnormal (MSQ) | Corresponding to the results of the mental state questionnaire at the admission patients are evaluated able to judge or not able to judge. An analysis of subgroup-effect for the other outcome variables will be done. | one year | 
| Peri-operative factors | Blood loss (estimated by anesthesiologist and surgeon) and blood transfusion (amount) Duration of surgery (skin-incision - skin closure) | Peri-operative period, i.e. time between admission until day 5 postoperative, expected average period of 5-8 days | 
| Timed up and go test (TUG) | see primary outcome measure | day 5, 6 weeks, 3 month and 1 year postoperatively (each +/- 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip fracture, hemiarthroplasty, endoprosthesis, elderly, minimally invasive surgery, anterior approach, geriatric patients