EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Joint Disease
• Intervention / Treatment: Device: Total Hip Arthroplasty

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 512

Contacts and Locations

Study Locations

• Belgium
  • Moerlandstraat 1
    • Sint-Niklaas, Moerlandstraat 1, Belgium, 9100
      • AZ Nikolaas
• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital
• Finland
  • Helsinki, Finland, FI-00029
    • Helsinki University Hospital
  • Turku, Finland, 20880
    • TYKS Turku University Hospital
• Germany
  • Püttlingen, Germany, 66346
    • Knappschaftskrankenhaus Püttlingen
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Medisch Centrum Alkmaar
• Spain
  • Madrid, Spain, 28046
    • University Hospital La Paz
• United Kingdom
  • Birmingham, United Kingdom, B 31 2AP
    • The Royal Orthopaedic Hospital, NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This clinical study can fulfill its objectives only if appropriate subjects are enrolled. All relevant medical and non-medical conditions should be taken into consideration when deciding whether a particular patient is suitable. Subjects will be enrolled consecutively.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision for any reason	Implant survivorship at 10 years post study procedure. 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.	10 years post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)	The HOOS is developed as an instrument to assess the subject's opinion about their hip and associated problems. HOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec), and hip related Quality of Life (QOL). Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	10 years post-op
Patient Reported Outcome (PRO): modified Harris Hip Score (HHS)	Effectiveness assessed by comparison of changes in parameters from baseline through 10 year post. 2 subscales (8 items), Scores summed and normalized to 100, Excellent: 90 - 100 points Good: 80 - 89 points Fair: 70 - 79 points Poor: < 70 points.	10 years post-op
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) rating	UCLA Activity Score is a measure of physical activity levels in subjects undergoing total joint arthroplasty. The scale is from 1 - 10 with higher values indicating greater physical function.	10 years post-op
Safety Assessment	Safety will be measured by assessing all adverse events experienced by patients up to study completion or termination.	10 years post-op

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Principal Investigator: Remes, Associate Professor, University of Helsinki

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2009
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; Degenerative joint disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: SR 16-4845-15 (R11019)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No