Hemi Artificial Hipjoint Versus Total Artificial Hipjoint (THA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01432691
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : April 18, 2017
Information provided by (Responsible Party):
Jakob Klit, Hvidovre University Hospital

Brief Summary:
This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint replacement.

Condition or disease Intervention/treatment Phase
Optimized Treatment Procedure: Hemi (hemialloplastik) Phase 4

Detailed Description:
Seventy patients over seventy years who are admitted in our hip fracture department with the indication for hemi joint replacement therapy, due to a Garden 3-4 femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt are randomized to either hemialloplastik or total joint replacement. The patients are followed for 24 mouths with X-ray Stereo Photogrammetric Analysis (RSA) radiographs and clinical examinations.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical and RSA Comparison of Hemi Versus Total Hip Arthroplasty After Displaced Femoral Neck Fracture. A Randomized Double-Blind Study
Study Start Date : June 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
RSA study on hemi
Procedure: Hemi (hemialloplastik)
THA vs hemi
Other Name: BFX: Biomet CE-number: 00520

Primary Outcome Measures :
  1. Radiographic and clinical [ Time Frame: Five years ]

    Migration / rotation: Migration is measured by X-ray Stereo Photogrammetric Analysis (RSA).

    Clinical assessment: The patient is assessed clinically using the WOMAC and EQ-5D.

Secondary Outcome Measures :
  1. Clinical [ Time Frame: Five years ]

    Implant Placement:

    Mobilisation: Patient mobilization level before the fracture is assessed by the New Mobility Score.Under hospital assessed patients' ability to time with current time instrument daily using the Cumulated ambulation score (CAS).

    Bleeding: Perioperative bleeding set in operation description from start to suture the incision closed. Hgb is measured as standard on the third day in all patients in the hip fracture unit. In addition, registered the need for blood transfusions in the first four postoperative days.

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients over 70 years, admitted two our hip-fracture department with a 3-4 Garden femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt.

    • Preoperative New Mobility Score ≥ 6th
  • Patients must be able to speak and understand Danish.
  • Patients must be able to give informed consent and be cognitively intact (Hindsøe score ≥ 6).
  • Patients should be expected to be able to implement the postoperative controls. Patients should not be medically ill: ASA-score ≤ 3rd

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01432691

Hvidovre University Hospital, Copenhagen
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital

Responsible Party: Jakob Klit, MD, Hvidovre University Hospital Identifier: NCT01432691     History of Changes
Other Study ID Numbers: 19761979
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

Keywords provided by Jakob Klit, Hvidovre University Hospital: