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NCT Number: NCT04399928

EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.

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Key information

Conditions

Degenerative Joint Disease Joint Diseases Musculoskeletal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Nikolaas, Sint-Niklaas, Moerlandstraat 1, Belgium

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About this study

This is a multicenter prospective observational post-market clinical follow-up study that will include 500 patients who will have total hip replacement with the R3 Acetabular System and either cemented or cementless hip stem.

Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA Rating. Safety will be measured by assessing all adverse events experienced by patients from study enrolment through to study completion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet all of the following characteristics for inclusion in the study.

  • 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 (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/DDH or inflammatory joint disease (e.g., rheumatoid 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
  • The patient is willing to comply the follow-up schedule

Exclusion criteria

Subjects with any of the following characteristics must be excluded from the participation in the study.

  • Patient has active infection or sepsis (treated or untreated)
  • Patient is a prisoner or has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse.
  • Patients with acute hip trauma (femoral neck fracture)

Treatment and study plan

Total hip arthroplasty

Device

Total hip arthroplasty with the R3 Acetabular Hip system.

Primary outcomes

  1. Implant Survivorship

    Time frame: up to 10 years post-operatively

    Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants.

Secondary outcomes

  1. Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)

    Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years

    HOOS is a measurement of function and outcomes of daily living that ranges from 0 to 100 where 0 indicated extreme symptoms (i.e., worse outcome) and 100 indicated no symptoms (i.e., better outcome).

  2. Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)

    Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years

    The mHHS scoring assessment ranges from 0 (worst) to 100 (best). Scores assessed during the pre-operative, 3-year, 5-year, 7-year and 10-year visit.

  3. Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating

    Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years

    UCLA Activity Score is a measure of physical activity levels in participants undergoing total joint arthroplasty. The scale ranges from 1 to 10 with higher scores indicating greater physical function (i.e., a better outcome).

  4. Radiographic Findings: Atrophy

    Time frame: 1 years, 3 years, 5 years, 7 years, 10 years

    Number of participant hips with radiographic findings for atrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years for the following:

    • Atrophy in any Cup Zones
    • Atrophy in any Stem Zones

  5. Radiographic Findings: Hypertrophy

    Time frame: 1 years, 3 years, 5 years, 7 years, 10 years

    Number of participant hips with radiographic findings for hypertrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years for the following:

    • Hypertrophy in any Cup Zones
    • Hypertrophy in any Stem Zones

  6. Radiographic Findings: Osteolysis

    Time frame: 1 years, 3 years, 5 years, 7 years, 10 years

    Number of participant hips with radiographic findings for osteolysis greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years as the following:

    • Osteolysis > 2mm in any Cup Zones
    • Osteolysis > 2mm in any Stem Zones

  7. Radiographic Findings: Radiolucent Lines (RLL)

    Time frame: 1 years, 3 years, 5 years, 7 years, 10 years

    Number of participant hips with radiographic findings for radiolucent lines (RLL) greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years as the following:

    • RLL > 2mm in any Cup Zones
    • RLL > 2mm in any Stem Zones

Sponsors and collaborators

Lead sponsor

Smith & Nephew Orthopaedics AG

Industry

Registry information

Official study title

A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3◊ Acetabular System in Patients With Degenerative Hip Disease

Important dates

Study start
2009
Primary completion
2022
Study completion
2022
First posted
May 22, 2020
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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