R3 Delta Ceramic Acetabular System PAS U.S. (R3-PAS)

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US

R3 Delta Post-Approval Study U.S.

Study Overview

• Status: Completed
• Conditions: Degenerative Joint Disease
• Intervention / Treatment: Device: R3 Biolox Delta Ceramic Acetabular System

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.

• Study Type: Observational
• Enrollment (Actual): 189

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Foundation for Orthopaedic Research and Education
  • Georgia
    • Tucker, Georgia, United States, 30084
      • Emory University
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Luminis Health
    • Baltimore, Maryland, United States, 21215
      • Rubin Institute for Advanced Orthopedics, Sinai Hospital
  • Nevada
    • Reno, Nevada, United States, 89503
      • Reno Orthopaedic Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania, Department of Orthopaedic Surgery
  • Texas
    • Austin, Texas, United States, 78750
      • St. David's Center for Hip and Knee Replacement
    • Houston, Texas, United States, 77043
      • INOV8 Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

To eliminate the potential for selection bias, Investigators should consecutively pre-screen all subjects undergoing planned total hip replacement with the R3 delta Ceramic Acetabular System.

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 (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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Study Success at 3 Years Postoperative	Number of participants with overall study success were identified as "Success" or "Failure" where success indicated all the following: No component revision for any reason; Modified Harris Hip Score (mHHS) greater than or equal to 80 points; No radiographic failure (Radiographic failure was defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones, no femoral or acetabular subsidence greater than or equal to 5 mm from baseline, and no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score.)	3 Years Postoperative
Component Revisions at 3 Years Postoperative	Number of participants component revisions identified as "Success" or "Failure" with success defined as no component revision for any reason.	3 Years Postoperative
Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points	The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The modified Harris Hip Score (mHHS) includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranges from 0 (worst) to 95 (best). The number of participants were identified as "Success" or "Failure" with success defined as a mHHS that is greater than or equal to 80 points.	3 Years postoperative
Overall Radiographic Success at 3 Years Postoperative	Number of participants with overall radiographic success identified as "Success" or "Failure" where success indicated all of the following: No radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones; No femoral or acetabular subsidence greater than or equal to 5 mm from baseline; No acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score	3 Years Postoperative
Number of Participants With Absence of Radiolucency at 3 Years Postoperative	Number of participants identified as "Success" or "Failure" with success defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones	3 Years postoperative
Number of Participants With Absence of Femoral Subsidence or Acetabular Migration at 3 Years Postoperative	Number of participants identified as "Success" or "Failure" with success defined as no femoral subsidence or acetabular migration greater than or equal to 5 millimeters (mm) from baseline.	3 Years postoperative
Number of Participants With Absence of Acetabular Cup Inclination Changes Greater Than 4 Degrees From Baseline at 3 Years Postoperative	Number of participants identified as "Success" or "Failure" with success defined as no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score.	3 Years postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Hip Harris Score (mHHS)	The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The modified Harris Hip Score (mHHS) includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranges from 0 (worst) to 95 (best).	Preoperative, 3 months, 1 year, 2 years, 3 years
Radiographic Findings: Number of Participants With Absence of Radiolucency	The number of participants identified as either "Success" or "Failure" with success defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" pain modified Harris Hip Score (mHHS).	3 months, 1 year, 2 years
Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration	The number of participants identified as either "Success" or "Failure" with success defined as no femoral subsidence or acetabular migration greater than or equal to 5 millimeters (mm) from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" pain modified Harris Hip Score (mHHS).	3 months, 1 year, 2 years
Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes	Number of participants identified as "Success" or "Failure" with success defined as no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" pain modified Harris Hip Score (mHHS).	3 months, 1 year, and 2 years
Implant Survivorship Kaplan-Meier Estimate	The Kaplan-Meier estimate of implant survivorship was measured from date of surgery to date of final visit with survival defined as no revision for any reason. A revision indicated reoperation was needed where any component (acetabular cup, acetabular liner, femoral head, or femoral stem) was replaced.	Postoperatively, up to 3 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2018
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Degenerative Joint Disease; Primary Total Hip Arthroplasty; Non-Inflammatory Arthritis; R3 Delta Ceramic Acetabular Insert
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Joint Diseases; Osteoarthritis
• Other Study ID Numbers: 16-4565-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No