Femoral Neck Fracture
Conditions
Keywords
hip fracture, hemiarthroplasty, endoprosthesis, elderly, minimally invasive surgery, anterior approach, geriatric patients
Brief summary
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
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.
Interventions
PROCEDURETrans-gluteal approach, CLAS
Classic lateral, trans-gluteal approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
PROCEDUREAnterior minimal invasive approach, AMIS
Minimal invasive Hueter anterior approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go test (TUG) | 3 weeks postoperatively +/- 3 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | duration from surgery until 1 year postoperatively | 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 |
| Peri-operative delirium | duration from admission to day 3, an expected average period of 3-5 days | 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). |
| One year mortality | one year | — |
| Functional Independence measure (FIM) | 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 ) | 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. |
| Subgroup effect of patients with normal Mental-state Questionnaire (MSQ) versus patients with abnormal (MSQ) | one year | 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. |
| Peri-operative factors | Peri-operative period, i.e. time between admission until day 5 postoperative, expected average period of 5-8 days | Blood loss (estimated by anesthesiologist and surgeon) and blood transfusion (amount) Duration of surgery (skin-incision - skin closure) |
| Timed up and go test (TUG) | day 5, 6 weeks, 3 month and 1 year postoperatively (each +/- 3 days) | see primary outcome measure |
| Length of hospitalization | duration of the hospital stay, an expected average of 10 days | — |
Countries
Switzerland
Outcome results
None listed