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

Phase 4

Completed

• Conditions: Femoral Neck Fracture
• Interventions: Procedure: Trans-gluteal approach, CLAS; Procedure: Anterior minimal invasive approach, AMIS

• Registration Number: NCT01408693
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2011-06-10
• Study Start: 2011-08
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2015-04
• Study Completion: 2016-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-gluteal approach, CLAS	Trans-gluteal approach, CLAS	CLAS in 95 randomized patients.
Anterior minimal invasive approach, AMIS	Anterior minimal invasive approach, AMIS	AMIS in 95 randomized patients.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Length of hospitalization	duration of the hospital stay, an expected average of 10 days
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)
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.
Timed up and go test (TUG)	day 5, 6 weeks, 3 month and 1 year postoperatively (each +/- 3 days)	see primary outcome measure
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.
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

Trial Locations

Locations (1)

Department of Traumatology, University Hospital; 🇨🇭 Basel, Switzerland