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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Device: OXINIUM DH Hip System; Device: BIOLOX◊

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.

• Study Type: Interventional
• Enrollment (Actual): 413

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 22 and 79 years, inclusive;
• Subject is skeletally mature in Investigator's judgment;
• Subject has a non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant requiring unilateral primary total hip replacement;
• Preoperative (within 28 days prior to the surgery) total Harris Hip Score of less than 70;
• Subject is a suitable candidate for primary total hip replacement at the discretion of the investigator;
• Subject has given consent to participate in the study after the nature, scope, and possible consequences of the study have been explained in an understandable form;
• Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.

Exclusion Criteria:

• Subject has had a previous total hip replacement, hemi-arthroplasty, or fusion in either hip;
• Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations in the other (not study) hip;
• Subject has a known allergy to any component of the devices used in the study;
• Subject with an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible;
• Subject with total or partial absence of the muscular or ligamentous apparatus of the hip joint to be operated;
• Subject has a congenital disorder or deformity of the affected limb or significant anatomic variance of the affected hip (based on Investigator's discretion);
• Subject has an active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
• Subjects with carcinoma in situ of the uterine cervix definitively treated more than 1 year prior to enrollment may enter the study;
• Subject has rheumatoid arthritis;
• Subject has a Body Mass Index > 40;
• Subject has an active infection (e.g. hepatitis, Acquired Immunodeficiency Syndrome, AIDS related Complex) - systemic or at the site of intended surgery;
• Subject has contralateral lower extremity condition causing abnormal ambulation and noncompliance with rehabilitation;
• Prior proximal femur fracture and/or presence of malunion, nonunion, and the surgical side;
• Subject has conditions that may interfere with THA survival or outcome (e.g., Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes defined by HgbA1c > 7%, or neuromuscular disease);
• Subject has systemic steroid therapy with 1 month prior to surgery;
• Subject is on drug therapy for the index hip with intra-articular corticosteroid therapy or any intra-articular therapy within 3 months of enrollment into the study;
• Subject has a life expectancy less than 10 years;
• Subject is female and of child bearing age who is currently pregnant or not using contraception;
• Subject has known moderate to severe renal insufficiency;
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse;
• Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation;
• Subject is unable, unwilling, or in the Investigator's opinion unlikely to return for or participate in follow-up visits at the investigational site;
• Subject is facing current or impending incarceration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OXINIUM DH Hip System; Oxinium DH◊ Hip System (Smith & Nephew), Smith & Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.	Device: OXINIUM DH Hip System; Investigational Group: OXINIUM DH Hip System
Active Comparator: BIOLOX◊; BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.	Device: BIOLOX◊; Control Group: BIOLOX◊ delta ceramic heads and XLPE liners

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 SuccessHarris 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, andNo femoral or acetabular subsidence greater than or equal to 5mm from baseline, andNo acetabular cup inclination changes greater than 4 degrees.; Absence of RevisionNo reoperations that led to removal or replacement of any of the acetabular or femoral components	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).	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.	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.	730 days
Radiographic Success at 730 Days Postoperative - Acetabular Cup Inclination in Participants With a Unilateral Hip Implant	Number of participants with radiographic success for acetabular cup inclination where success indicated no acetabular cup inclination changes greater than 4 degrees.	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.	730 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 730 days

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 21, 2021
• Study Completion (Estimated): February 7, 2030

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (Estimated): February 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: osteoarthritis; avascular necrosis; traumatic arthritis; NIDJD; non-inflammatory arthritis; slipped capital epiphysis; fused hip; fracture of pelvis; diastrophic variant
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Leg Injuries; Necrosis; Fractures, Bone; Femoral Fractures; Hip Injuries; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Hip Fractures; Osteoarthritis, Hip; Osteonecrosis
• Other Study ID Numbers: 2012-ODH-86