Metal-metal Articulations Versus Standard 28 mm Cementless Total Hip Arthroplasty

Summary

Younger hip patients often need revision of their hip replacement due to wear and loosening. Newer concepts (resurfacing and large head total hip replacement) with articulation surfaces in metal may reduce the wear, increase the longevity of the implant and give an improved function. The possible downside is that these concepts releases metal debris to the body. The investigators wish to see if the newer interventions are a clinical improvement compared to standard. The investigators also wish to investigate the extent of metal released to the body and any effect on the immune system. Finally the investigators wish to investigate the stability of these new implants and their ability to preserve the bone around the implant.

The investigators hypothesis is:

That the metal on metal articulations will not have better clinical outcomes than standard The resurfacing implant is expected to preserve the bone of the upper femoral bone. The implants are expected to be stabile within the first year.

Conditions

• Osteoarthritis, Hip

Interventions

DEVICE

articular surface replacement ASR, DePuy

posterolateral incision

DEVICE

ReCap/Magnum modular head, Biomet

posterolateral incision

DEVICE

Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet

posterolateral incision

DEVICE

28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)

posterolateral incision

Sponsors & Collaborators

• Ministry of the Interior and Health, Denmark

  collaborator OTHER_GOV

• Region Zealand

  collaborator OTHER

• Zimmer Biomet

  collaborator INDUSTRY

• DePuy Orthopaedics

  collaborator INDUSTRY

• University of Southern Denmark

  lead OTHER

Principal Investigators

• Soeren Overgaard, MD, professor, phd · University of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-02-28

Primary Completion

2009-11-30

Completion

2019-11-30

Countries

• Denmark

Study Locations