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Hemi Artificial Hipjoint Versus Total Artificial Hipjoint (THA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Jakob Klit, Hvidovre University Hospital Identifier:
First received: September 9, 2011
Last updated: September 12, 2011
Last verified: September 2011
This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint replacement.

Condition Intervention Phase
Optimized Treatment
Procedure: THA (Total hip arthroplasty) versus Hemi (hemialloplastik)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Radiographic and clinical [ Time Frame: Five years ] [ Designated as safety issue: No ]

    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:
  • Clinical [ Time Frame: Five years ] [ Designated as safety issue: No ]

    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.

Estimated Enrollment: 70
Study Start Date: June 2010
Estimated Study Completion Date: June 2015
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
THA or hemi
Procedure: THA (Total hip arthroplasty) versus Hemi (hemialloplastik)
THA vs hemi
Other Name: BFX: Biomet CE-number: 00520

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.

Ages Eligible for Study:   70 Years and older   (Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01432691

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

Responsible Party: Jakob Klit, MD, Hvidovre University Hospital Identifier: NCT01432691     History of Changes
Other Study ID Numbers: 19761979 
Study First Received: September 9, 2011
Last Updated: September 12, 2011
Health Authority: denmark: cvk

Keywords provided by Hvidovre University Hospital:
RSA processed this record on December 08, 2016