R3 Delta Ceramic Acetabular System PAS U.S.

Overview

R3 Delta Post-Approval Study U.S.

Full Title of Study: “Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System – US”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 31, 2023

Detailed Description

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System – US The R3 Ceramic Acetabular System is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. The expected timeline for the study is a total of approximately 5 years: 6 months for site initiation, 12 months for subject enrollment, 3 years until the last subject enrolled has reached the 3 year follow-up interval.

Interventions

  • Device: R3 Biolox Delta Ceramic Acetabular System
    • All study related procedures with the R3 delta Ceramic Acetabular System must be performed according to the recommended surgical technique described in the labeling and in the instructions for use (IFU).

Clinical Trial Outcome Measures

Primary Measures

  • Overall success at 3 years postoperative defined as no component revision
    • Time Frame: 3 Years postoperative
    • No component revision
  • Overall success at 3 years postoperative defined as Modified Harris Hip Score of at least 80 points
    • Time Frame: 3 Years postoperative
    • Modified Harris Hip Score of at least 80 points
  • Overall success at 3 years postoperative no radiographic failure defined as: no radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones
    • Time Frame: 3 Years postoperative
    • No Radiographic Failure
  • Overall success at 3 years postoperative defined as No femoral or acetabular subsidence greater than or equal to 5 mm from baseline
    • Time Frame: 3 Years postoperative
    • No Radiographic Failure
  • Overall success at 3 years postoperative defined as no acetabular cup inclination changes greater than 4 degrees from baseline.
    • Time Frame: 3 Years postoperative
    • No Radiographic Failure

Secondary Measures

  • Secondary endpoints include clinical assessments of pain and function using the Modified Hip Harris Score
    • Time Frame: 3 Years postoperative
    • Assessment of pain and function
  • Secondary endpoints include clinical assessments of radiographic findings
    • Time Frame: 3 Years postoperative
    • Radiographic Findings
  • Secondary endpoints include clinical assessments of implant survivorship.
    • Time Frame: 3 Years postoperative
    • Implant survivorship

Participating in This Clinical Trial

Inclusion Criteria

  • Patient is 18-75 years old and he/she is skeletally mature – Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. – Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk – Patient is willing and able to participate in required follow-up visits and to complete study procedures and questionnaires – Patient has consented to participating in the study by signing the IRB/EC approved informed consent form Exclusion Criteria:

  • Patients with insufficient quantity or quality of bone support; metabolic bone disease; osteoporosis – Patients with neurological or muscular conditions that would place extreme load or instability upon the hip joint – Patients with active joint infections or chronic systemic infection – Obese patients where obesity is defined as BMI > 40 – Skeletal immaturity – Known allergy to implant materials

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Investigator Details

  • Lead Sponsor
    • Smith & Nephew, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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