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Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures (MIS-CLAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01408693
First received: June 10, 2011
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
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).

Condition Intervention Phase
Femoral Neck Fracture
Procedure: Trans-gluteal approach, CLAS
Procedure: Anterior minimal invasive approach, AMIS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures - A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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

  • 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).

  • One year mortality [ Time Frame: one year ]
  • Length of hospitalization [ Time Frame: 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) [ 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.

  • 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)

  • 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


Enrollment: 190
Study Start Date: August 2011
Estimated Study Completion Date: April 2017
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anterior minimal invasive approach, AMIS
AMIS in 95 randomized patients.
Procedure: Anterior minimal invasive approach, AMIS
Minimal invasive Hueter anterior approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
Other Name: Medacta, Mathys, Switzerland
Active Comparator: Trans-gluteal approach, CLAS
CLAS in 95 randomized patients.
Procedure: Trans-gluteal approach, CLAS
Classic lateral, trans-gluteal approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
Other Name: Mecacta, Mathys, Switzerland

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

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01408693

Locations
Switzerland
Department of Traumatology, University Hospital
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Marcel Jakob, Professor Department of Traumatology, University hospital Basel
Principal Investigator: Patrick Studer, MD Department of Traumatology, UHBS
  More Information

Publications:

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01408693     History of Changes
Other Study ID Numbers: UHBS-TRAUMA-68/11
Study First Received: June 10, 2011
Last Updated: January 5, 2017

Keywords provided by University Hospital, Basel, Switzerland:
hip fracture
hemiarthroplasty
endoprosthesis
elderly
minimally invasive surgery
anterior approach
geriatric patients

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 25, 2017