NCT03692364

Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty

Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.

Conditions

• Arthroplasty Complications

Interventions

Type	Name	Description
DEVICE	Ceramic-on-ceramic uncemented hip arthroplasty
DEVICE	Metal-on-polyethylene uncemented total hip arthroplasty

Timeline

• Start date: 2003-10-02
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-10-02
• Last updated: 2018-10-02

Regulatory

• FDA-regulated device study