NCT01113762

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

Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-11-01
• Completion: 2019-11-01
• First posted: 2010-04-30
• Last updated: 2017-12-19

Locations

2 sites across 1 country: Denmark