OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study

NCT02353377 | Active Not Recruiting Results

• 1 other identifier: 2012-ODH-86
• Study Type: interventional
• Target: 413
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Hip Osteoarthritis

Keywords

NIDJD; osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of pelvis; diastrophic variant; non-inflammatory arthritis

Outcome Measures

Primary Outcomes (6)

• 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

  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 Outcomes (1)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 730 Days Postoperatively

  Baseline to 730 days

Study Arms (2)

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.

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.

Device: BIOLOX◊

Interventions

OXINIUM DH Hip System DEVICE

Investigational Group: OXINIUM DH Hip System

OXINIUM DH Hip System

BIOLOX◊ DEVICE

Control Group: BIOLOX◊ delta ceramic heads and XLPE liners

BIOLOX◊

Eligibility Criteria

• Age: 22 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis; Osteonecrosis; Hip Fractures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

07811407089

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: September 21, 2021
• Study Completion (Estimated): February 7, 2030
• Last Updated: March 19, 2026
• Results First Posted: March 19, 2026

Record last verified: 2025-11