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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
413
Investigational Group: OXINIUM DH Hip System
Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
Overall Success at 730 Days Post-operative in Participants With a Unilateral Hip Implant
To be classified as overall success, the participant must meet all of the following criteria: * Clinical Success * Harris Hip Score of 80 or more at the 730-day follow-up time point. * Radiologic success at the 730-day follow-up time point defined as: * No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones, and * No femoral or acetabular subsidence greater than or equal to 5mm from baseline, and * No acetabular cup inclination changes greater than 4 degrees. * Absence of Revision * No reoperations that led to removal or replacement of any of the acetabular or femoral components
Time frame: 730 days
Number of Unilateral Hip Implant Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points
The number of participants with a modified Harris Hip Score (mHHS) greater than or equal to 80 points. The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The mHHS includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranged from 0 (worst) to 95 (best).
Time frame: 730 days
Radiographic Success at 730 Days Postoperative - Radiolucencies in Participants With a Unilateral Hip Implant
Number of participants with radiographic success for radiolucencies where success indicated no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones.
Time frame: 730 days
Radiographic Success at 730 Days Postoperative - Femoral or Acetabular Subsidence in Participants With a Unilateral Hip Implant
Number of participants with radiographic success for femoral or acetabular subsidence where success indicated no femoral or acetabular subsidence greater than or equal to 5 millimeters (mm) from baseline.
Time frame: 730 days
Radiographic Success at 730 Days Postoperative - Acetabular Cup Inclination in Participants With a Unilateral Hip Implant
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Number of participants with radiographic success for acetabular cup inclination where success indicated no acetabular cup inclination changes greater than 4 degrees.
Time frame: 730 days
Number of Unilateral Hip Implant Participants With Absence of Revision at 730 Days Postoperative
Number of participants with absence of revision defined as no reoperations that led to removal or replacement of any of the acetabular or femoral components.
Time frame: 730 Days
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 730 Days Postoperatively
The WOMAC is a 24 item subject-reported self-assessment questionnaire. It evaluates pain (5 questions), stiffness (2 questions), and functional limitation (17 questions) in knee and hip osteoarthritis. In this study, version 3.0 of the instrument is used, which employs a 5-point Likert scale ranging from none (0) to extreme (4). The Functional Limitations Score takes values from 0 (no problems) to 68 (extreme problems). Scores are transformed to a score from 0 to 100, with a lower score indicating a better outcome.
Time frame: Baseline to 730 days