NCT01918540

Importance of Hollow or Solid Centralizer for Polished, Collarless and Tapered Stems in Total Hip Arthroplasty

Comparing Hollow and Solid Centralizer Designs When Using a Polished, Collarless, Tapered Hip Prosthesis Stem (MS30). A Prospective, Randomized, Multicenter Study Evaluated by RadioStereometric Analysis (RSA).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The study aims at comparing the effect of hollow or solid centralizer designs on the long time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. In a prospective, controlled and randomized study comprising two groups of 30 patients/hips each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In completion general health questionnaires as well as hip specific scoring instruments will be used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the different centralizers will result in different migration patterns of the stems, which might affect the risk for late aseptic loosening.

Conditions

• Total Hip Arthroplasty

Interventions

Type	Name	Description
PROCEDURE	Hollow Centralizer	The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer
PROCEDURE	Solid Centralizer	The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer
DEVICE	MS-30 femoral stem	This is the stem used in the study.

Timeline

• Start date: 2003-02-01
• Primary completion: 2004-02-01
• Completion: 2014-11-01
• First posted: 2013-08-07
• Last updated: 2014-11-26

Locations

1 site across 1 country: Sweden