Hemi Artificial Hipjoint Versus Total Artificial Hipjoint (THA)

This study is currently recruiting participants.
Verified September 2011 by Hvidovre University Hospital
Sponsor:
Information provided by (Responsible Party):
Jakob Klit, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01432691
First received: September 9, 2011
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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
Surgery
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432691

Contacts
Contact: Jakob Klit, MD 004551368690 j.klit1@gmail.com
Contact: Anders Troelsen, MD, PhD 004527337008 a_troelsen@hotmail.com

Locations
Denmark
Hvidovre University Hospital, Copenhagen Recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Jakob Klit, MD    004551368690    j.klit1@gmail.com   
Contact: Anders Troelsen, MD,PhD    004527337008    a_troelsen@hotmail.com   
Principal Investigator: Jakob Klit, MD         
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Jakob Klit, MD, Hvidovre University Hospital
ClinicalTrials.gov 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:
Hip-fracture
RSA

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

ClinicalTrials.gov processed this record on April 17, 2014