NCT02353377

OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study

A Multi-Center, Randomized Controlled Study of Efficacy and Safety of the OXINIUM◊ DH Total Hip Replacement System in Subjects With Non-Inflammatory Arthritis

• Status: Active Not Recruiting
• Phase: —
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 22 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to monitor safety of the participants implanted with the OXINIUM◊ DH Hip System up to 10-years post-implantation

Detailed description

This is a prospective, multi-center, interventional, randomized controlled study to investigate the safety and efficacy of the OXINIUM◊ DH Hip System (Smith \& Nephew, Inc., Memphis, TN, USA). The study will follow all enrolled Subjects for 3 years and investigational Subjects for 10 years (primary safety endpoint) in total. Subjects meeting inclusion and exclusion criteria will receive THA and will be randomized to receive implantation of the Investigational or Control Device. The post-operative rehabilitation will be per standard of care at the treating institution. Up to 20 US and 10 out-of-US (OUS) enrolling investigational sites will participate in this study.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
DEVICE	OXINIUM DH Hip System	Investigational Group: OXINIUM DH Hip System
DEVICE	BIOLOX◊	Control Group: BIOLOX◊ delta ceramic heads and XLPE liners

Timeline

• Start date: 2015-01-01
• Primary completion: 2021-09-21
• Completion: 2030-02-07
• First posted: 2015-02-02
• Last updated: 2026-03-19
• Results posted: 2026-03-19