Hip OsteoarthritisNCT02353377

OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study

A study testing OXINIUM DH Hip System and BIOLOX◊ in people with Hip Osteoarthritis, run by Smith & Nephew, Inc..

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial 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 Read more about this study

Who is it for?: Ages 22 to 79 years
Conditions the study is for: Hip Osteoarthritis
What is being tested?: OXINIUM DH Hip System and BIOLOX◊
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 413 participants
Where: No sites listed yet
Study dates: Jan 2015to 7 Feb 2030
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

Show all 23Show fewer

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.

About this study

Official title: 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

Read the 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
Being tested: OXINIUM DH Hip System, BIOLOX◊
Keywords: NIDJD, osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of pelvis, diastrophic variant, non-inflammatory arthritis
Medical subject headings: Osteoarthritis, Hip, Osteoarthritis, Osteonecrosis, Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OXINIUM DH Hip SystemDevice
Investigational Group: OXINIUM DH Hip System
BIOLOX◊Device
Control Group: BIOLOX◊ delta ceramic heads and XLPE liners

Study groups in NCT02353377
Study group	Role	What they receive
OXINIUM DH Hip System	Active comparator	Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem. Receives: Device: OXINIUM DH Hip System
BIOLOX◊	Active comparator	BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem. Receives: Device: BIOLOX◊

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 730 Days

Secondary outcomes (1)

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.
Measured: Baseline to 730 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 20157 Feb 2030

First posted2 Feb 2015 (estimated)
Study startJan 2015
Primary completion21 Sep 2021
Study completion7 Feb 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 413 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02353377
Sponsor's protocol ID: 2012-ODH-86
Status last verified: Nov 2025
First submitted: 27 Jan 2015
Last updated: 19 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hip Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized Controlled Study of Efficacy and Safety of the OXINIUM◊ DH Total Hip Replacement System in Subjects With Non-Inflammatory Arthritis
ClinicalTrials.gov ID: NCT02353377
Acronym / sponsor ID: 2012-ODH-86
Conditions: Hip Osteoarthritis
Keywords: NIDJD, osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of pelvis, diastrophic variant
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 413 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: 21 Sep 2021 (actual)
Study completion: 7 Feb 2030 (estimated)
First posted: 2 Feb 2015 (estimated)
Results: Posted 19 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
OXINIUM DH Hip System	Active comparator	Device: OXINIUM DH Hip SystemOxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊	Active comparator	Device: BIOLOX◊BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.

Who may qualify

Ages: 22 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (23 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OXINIUM DH Hip SystemInvestigational Group: OXINIUM DH Hip System	Device	OXINIUM DH Hip System
BIOLOX◊Control Group: BIOLOX◊ delta ceramic heads and XLPE liners	Device	BIOLOX◊

Primary outcome

Overall Success at 730 Days Post-operative in Participants With a Unilateral Hip Implant
Time frame: 730 days
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
Number of Unilateral Hip Implant Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points
Time frame: 730 days
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).
Radiographic Success at 730 Days Postoperative - Radiolucencies in Participants With a Unilateral Hip Implant
Time frame: 730 days
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.
Radiographic Success at 730 Days Postoperative - Femoral or Acetabular Subsidence in Participants With a Unilateral Hip Implant
Time frame: 730 days
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.
Radiographic Success at 730 Days Postoperative - Acetabular Cup Inclination in Participants With a Unilateral Hip Implant
Time frame: 730 days
Number of participants with radiographic success for acetabular cup inclination where success indicated no acetabular cup inclination changes greater than 4 degrees.
Number of Unilateral Hip Implant Participants With Absence of Revision at 730 Days Postoperative
Time frame: 730 Days
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.

1 secondary outcome

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 730 Days Postoperatively
Time frame: Baseline to 730 days

Results and safety

Results posted to the registry on 19 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OXINIUM DH Hip System	205	170
BIOLOX◊	208	152

Primary outcome: Overall Success at 730 Days Post-operative in Participants With a Unilateral Hip Implant

Time frame: 730 days. Count of participants. Unit: Participants

Measure	OXINIUM DH Hip System n = 198	BIOLOX◊ n = 204
Value	55	47

Population analysed: Unilateral hip implant participants with data collected for the outcome and time frame indicated

Primary outcome: Number of Unilateral Hip Implant Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points

Time frame: 730 days. Count of participants. Unit: Participants

Measure	OXINIUM DH Hip System n = 163	BIOLOX◊ n = 144
Value	144	136

Population analysed: Overall number of unilateral hip implant participants with data collected for the time frame indicated.

Primary outcome: Radiographic Success at 730 Days Postoperative - Radiolucencies in Participants With a Unilateral Hip Implant

Time frame: 730 days. Count of participants. Unit: Participants

Measure	OXINIUM DH Hip System n = 155	BIOLOX◊ n = 140
Value	150	136

Population analysed: Overall number of unilateral hip implant participants with data collected for the time frame indicated.

Primary outcome: Radiographic Success at 730 Days Postoperative - Femoral or Acetabular Subsidence in Participants With a Unilateral Hip Implant

Time frame: 730 days. Count of participants. Unit: Participants

Measure	OXINIUM DH Hip System n = 155	BIOLOX◊ n = 140
Value	154	140

Population analysed: Overall number of unilateral hip implant participants with data collected for the time frame indicated.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OXINIUM DH Hip System	56 of 205 (27.3%)	114 of 205 (55.6%)	1 of 205
BIOLOX◊	41 of 208 (19.7%)	92 of 208 (44.2%)	1 of 208

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hip Osteoarthritis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing OXINIUM DH Hip System and BIOLOX◊ in people with Hip Osteoarthritis, run by Smith & Nephew, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Success at 730 Days Post-operative in Participants With a Unilateral Hip Implant (time frame: 730 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02353377.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.