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NCT Number: NCT01408693

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

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).

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Key information

Conditions

Femoral Neck Fracture Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Traumatology, University Hospital

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Trans-gluteal approach, CLAS

Procedure

Classic lateral, trans-gluteal approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Other names: Mecacta, Mathys, Switzerland

Anterior minimal invasive approach, AMIS

Procedure

Minimal invasive Hueter anterior approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Other names: Medacta, Mathys, Switzerland

Primary outcomes

  1. Timed up and go test (TUG)

    Time frame: 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 outcomes

  1. Functional Independence measure (FIM)

    Time frame: 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.

  2. Postoperative complications

    Time frame: 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

  3. Peri-operative delirium

    Time frame: 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).

  4. One year mortality

    Time frame: one year

  5. Length of hospitalization

    Time frame: duration of the hospital stay, an expected average of 10 days

  6. Subgroup effect of patients with normal Mental-state Questionnaire (MSQ) versus patients with abnormal (MSQ)

    Time frame: 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.

  7. Peri-operative factors

    Time frame: 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)

  8. Timed up and go test (TUG)

    Time frame: day 5, 6 weeks, 3 month and 1 year postoperatively (each +/- 3 days)

    see primary outcome measure

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: MIS-CLAS

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Aug 3, 2011
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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