R3 Delta Ceramic Acetabular System PAS U.S.

Completed

Conditions: Degenerative Joint Disease

Registration Number: NCT03056534

Lead Sponsor: Smith & Nephew, Inc.

Brief Summary: R3 Delta Post-Approval Study U.S.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 189

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Component Revisions at 3 Years Postoperative	3 Years Postoperative	Number of participants component revisions identified as "Success" or "Failure" with success defined as no component revision for any reason.
Overall Study Success at 3 Years Postoperative	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.)
Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points	3 Years postoperative	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.
Overall Radiographic Success at 3 Years Postoperative	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
Number of Participants With Absence of Radiolucency at 3 Years Postoperative	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
Number of Participants With Absence of Femoral Subsidence or Acetabular Migration at 3 Years Postoperative	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.
Number of Participants With Absence of Acetabular Cup Inclination Changes Greater Than 4 Degrees From Baseline at 3 Years Postoperative	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.

Secondary Outcome Measures

Name	Time	Method
Implant Survivorship Kaplan-Meier Estimate	Postoperatively, up to 3 years	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.
Modified Hip Harris Score (mHHS)	Preoperative, 3 months, 1 year, 2 years, 3 years	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).
Radiographic Findings: Number of Participants With Absence of Radiolucency	3 months, 1 year, 2 years	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).
Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration	3 months, 1 year, 2 years	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).
Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes	3 months, 1 year, and 2 years	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).

Trial Locations

Locations (8): St. David's Center for Hip and Knee Replacement
🇺🇸
Austin, Texas, United States
Luminis Health
🇺🇸
Annapolis, Maryland, United States
INOV8 Healthcare
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Houston, Texas, United States
Foundation for Orthopaedic Research and Education
🇺🇸
Tampa, Florida, United States
Emory University
🇺🇸
Tucker, Georgia, United States
Rubin Institute for Advanced Orthopedics, Sinai Hospital
🇺🇸
Baltimore, Maryland, United States
Reno Orthopaedic Clinic Foundation
🇺🇸
Reno, Nevada, United States
University of Pennsylvania, Department of Orthopaedic Surgery
🇺🇸
Philadelphia, Pennsylvania, United States