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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
Patrick Studer, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01408693
First received: June 10, 2011
Last updated: August 30, 2011
Last verified: August 2011
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Length of hospitalization [ Time Frame: duration of the hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]
  • Subgroup effect of patients with normal Mental-state Questionnaire (MSQ) versus patients with abnormal (MSQ) [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    see primary outcome measure


Estimated Enrollment: 190
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408693

Contacts
Contact: Marcel Jakob, Professor +41 61 328 17 37 mjakob@uhbs.ch
Contact: Patrick Studer, Dr. +41 61 328 62 43 pstuder@uhbs.ch

Locations
Switzerland
Department of Traumatology, University Hospital Recruiting
Basel, Switzerland, 4031
Contact: Marcel Jakob, Prof.    +41 61 328 71 37    mjakob@uhbs.ch   
Contact: Patrick Studer, Dr.med.    +41 61 328 62 43    pstuder@uhbs.ch   
Sub-Investigator: Franziska Saxer, Dr.med.         
Sub-Investigator: Norbert Suhm, PD Dr.med.         
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: Patrick Studer, Dr.med., 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: August 30, 2011
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on October 23, 2014