NCT01917929

Secur-Fit Advanced Outcomes Study

A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Secur-Fit Advanced Hip Stem

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the Secur-Fit Advanced Hip Stem in primary total hip replacement surgery.

Detailed description

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Secur-Fit Advanced Hip Stem for primary total hip arthroplasty with a cementless application in a consecutive series of patients who meet the eligibility criteria. The primary objective of this study is to evaluate the success rate of cementless primary total hip replacement with the Secur-Fit Advanced Hip Stem. Success will be defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture at 5 years postoperative. It is expected that the success rate of the Secur-Fit Advanced Hip Stem group will be non-inferior to the selected reference rate of 99% at 5 years postoperative.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DEVICE	Secur-Fit Advanced Hip Stem	Straight femoral stem intended for cementless, press-fit application.

Timeline

• Start date: 2013-08-15
• Primary completion: 2023-05-01
• Completion: 2024-06-13
• First posted: 2013-08-07
• Last updated: 2025-07-23
• Results posted: 2024-11-27

Locations

8 sites across 1 country: United States