Clinical trial NCT01408693: Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures
Official title: Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures - A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Femoral Neck Fracture
Keywords: hip fracture
hemiarthroplasty
endoprosthesis
elderly
minimally invasive surgery
anterior approach
geriatric patients
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 190
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Timed up and go test (TUG)
timeFrame: 3 weeks postoperatively +/- 3 days
Secondary outcomes:
measure: Functional Independence measure (FIM)
timeFrame: 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 )
measure: Postoperative complications
timeFrame: duration from surgery until 1 year postoperatively
measure: Peri-operative delirium
timeFrame: duration from admission to day 3, an expected average period of 3-5 days
measure: One year mortality
timeFrame: one year
measure: Length of hospitalization
timeFrame: duration of the hospital stay, an expected average of 10 days
measure: Subgroup effect of patients with normal Mental-state Questionnaire (MSQ) versus patients with abnormal (MSQ)
timeFrame: one year
measure: Peri-operative factors
timeFrame: Peri-operative period, i.e. time between admission until day 5 postoperative, expected average period of 5-8 days
measure: Timed up and go test (TUG)
timeFrame: day 5, 6 weeks, 3 month and 1 year postoperatively (each +/- 3 days)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Traumatology, University Hospital
Study officials:
affiliation: Department of Traumatology, University hospital Basel
name: Marcel Jakob, Professor
role: PRINCIPAL_INVESTIGATOR
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