OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study

Sponsor
Smith & Nephew, Inc.
Study ID
NCT02353377
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • OXINIUM DH Hip System — DEVICE
    Investigational Group: OXINIUM DH Hip System
  • BIOLOX◊ — DEVICE
    Control Group: BIOLOX◊ delta ceramic heads and XLPE liners

Study Details

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

Key Dates

Start date
Jan 31, 2015
Status verified
Nov 2025
Primary completion
Sep 21, 2021
Completion
Feb 7, 2030

Study Design

Enrollment
413 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: BIOLOX◊
    BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.

Primary Outcome Measure

Overall Success at 730 Days Post-operative in Participants With a Unilateral Hip Implant [ Time Frame: 730 days ]

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