Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 189
- Locations
- 8
- Primary Endpoint
- Component Revisions at 3 Years Postoperative
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Component Revisions at 3 Years Postoperative
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Implant Survivorship Kaplan-Meier Estimate(Postoperatively, up to 3 years)
- Modified Hip Harris Score (mHHS)(Preoperative, 3 months, 1 year, 2 years, 3 years)
- Radiographic Findings: Number of Participants With Absence of Radiolucency(3 months, 1 year, 2 years)
- Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration(3 months, 1 year, 2 years)
- Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes(3 months, 1 year, and 2 years)