Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe (R3 EU PAS)

The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results.

Study Overview

• Status: Completed
• Conditions: Degenerative Joint Disease of Hip

Detailed Description

This PAS is a long-term follow-up of the R3 delta Ceramic Acetabular System (DOD) hips enrolled in the study that was analyzed for the Premarket Approval Application (PMA) Study. The PMA Study analyzed 3 Year postoperative follow-up data on Biolox delta ceramic-on-Biolox delta ceramic (DOD) and Oxidized zirconium-on-Crosslinked Polyethylene (OxZr/XLPE) hips, enrolled and followed in a European Post-market Study ("A prospective, multicenter, non-randomized, clinical outcome study of the R3 Acetabular System in patients with degenerative hip disease").

The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results. Hips are evaluated at the following intervals: 5, 7, 10 years postoperative. The primary study endpoint is implant survivorship at 10 years post surgery.

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• Belgium
  • Sint-Niklaas, Belgium
    • AZ Nikolaas
• Finland
  • Helsinki, Finland, 00029
    • HUS Peijaksen sairaala, Ortopedia ja traumatologia
  • Turku, Finland, 20880
    • TYKS Turku University Hospital
• Spain
  • Madrid, Spain, 28046
    • La Paz Hospital
• 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.

Description

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 (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/ developmental dysplasia of the hip) 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:

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?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Post Approval Study; The PAS cohort consisted of 137 subjects who were implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study. These patients will continue to be followed to 10 years post-operatively. The primary endpoint for the PAS study is implant survivorship at 10 years post study procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survivor rate	Did hip survive with no revision through 10 years	10 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Harris Hip Score	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
Radiographic outcomes	radiographic success 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 (4°)	10 Years
Adverse Events	All AEs will be collected and reported	10 Years

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Collaborators: Iqvia Pty Ltd; eResearchTechnology, Inc; M Squared Associates,Inc.; ExecuPharm PAREXEL

Publications and helpful links

General Publications

• Davis ET, Remes V, Virolainen P, Gebuhr P, Van Backlé B, Revell MP, Kopjar B. Mid-term outcomes of the R3™ delta ceramic acetabular system in total hip arthroplasty. J Orthop Surg Res. 2021 Jan 9;16(1):35. doi: 10.1186/s13018-020-02192-6.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases; Osteoarthritis, Hip
• Other Study ID Numbers: R11019

Drug and device information, study documents

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