R3 Delta Ceramic Acetabular System PAS U.S.

Smith & Nephew, Inc.189 enrolled

Overview

R3 Delta Post-Approval Study U.S.

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

189

Conditions

Degenerative Joint Disease

Interventions

R3 Biolox Delta Ceramic Acetabular SystemDEVICE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (8)

Foundation for Orthopaedic Research and Education

Tampa, Florida, United States

Emory University

Tucker, Georgia, United States

Luminis Health

Annapolis, Maryland, United States

Rubin Institute for Advanced Orthopedics, Sinai Hospital

Outcomes

Primary Outcomes

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.)

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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Secondary Outcomes

Modified Hip Harris Score (mHHS)

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: Postoperatively, up to 3 years