Hemi Artificial Hipjoint Versus Total Artificial Hipjoint (THA)

Clinical and RSA Comparison of Hemi Versus Total Hip Arthroplasty After Displaced Femoral Neck Fracture. A Randomized Double-Blind Study

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

Study Overview

• Status: Completed
• Conditions: Optimized Treatment
• Intervention / Treatment: Procedure: Hemi (hemialloplastik)

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
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre
    • Copenhagen, Hvidovre, Denmark, 2650
      • Hvidovre University Hospital, Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Surgery; RSA study on hemi	Procedure: Hemi (hemialloplastik); THA vs hemi; Other Names: BFX: Biomet CE-number: 00520

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic and clinical	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.	Five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical	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.	Five years

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 9, 2011
• First Submitted That Met QC Criteria: September 12, 2011
• First Posted (Estimate): September 13, 2011

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: RSA; Hip-fracture
• Other Study ID Numbers: 19761979

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No