NCT00510458

LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study

LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study - An Open Label, Prospective, Post-market, Multi-center Clinical Evaluation of the LFIT™ Anatomic CoCr Femoral Heads With X3® Inserts

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Total hip replacement surgery is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. The purpose of the study is to evaluate a large size (36mm, 40mm or 44mm) femoral (hip) head called the LFIT™ Anatomic CoCr Femoral Head (Low Friction Ion Treatment). The large size femoral heads will be used with the Trident® X3® polyethylene (plastic) inserts and will be compared with a historical control. Study Hypothesis: The linear wear rate for hips implanted with the LFIT™ Anatomic CoCr Femoral Head is no worse than 0.08 mm wear per year at 5 years post-surgery.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DEVICE	LFIT™ Femoral Heads With X3® Insert	LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement

Timeline

• Start date: 2007-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2007-08-02
• Last updated: 2018-03-12
• Results posted: 2018-03-12

Locations

5 sites across 1 country: United States