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Completed

NCT Number: NCT01432691

Hemi Artificial Hipjoint Versus Total Artificial Hipjoint

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

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Key information

Conditions

Optimized Treatment Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre University Hospital, Copenhagen

Copenhagen, Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemi (hemialloplastik)

Procedure

THA vs hemi

Other names: BFX: Biomet CE-number: 00520

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Acronym: THA

Important dates

Study start
2010
Primary completion
2011
Study completion
2015
First posted
Sep 13, 2011
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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