Clinical trial NCT03056534: R3 Delta Ceramic Acetabular System PAS U.S.
Official title: Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Joint Disease
Keywords: Primary Total Hip Arthroplasty
Non-Inflammatory Arthritis
Degenerative Joint Disease
R3 Delta Ceramic Acetabular Insert
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-17
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Study Success at 3 Years Postoperative
timeFrame: 3 Years Postoperative
measure: Component Revisions at 3 Years Postoperative
timeFrame: 3 Years Postoperative
measure: Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points
timeFrame: 3 Years postoperative
measure: Overall Radiographic Success at 3 Years Postoperative
timeFrame: 3 Years Postoperative
measure: Number of Participants With Absence of Radiolucency at 3 Years Postoperative
timeFrame: 3 Years postoperative
measure: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration at 3 Years Postoperative
timeFrame: 3 Years postoperative
measure: Number of Participants With Absence of Acetabular Cup Inclination Changes Greater Than 4 Degrees From Baseline at 3 Years Postoperative
timeFrame: 3 Years postoperative
Secondary outcomes:
measure: Modified Hip Harris Score (mHHS)
timeFrame: Preoperative, 3 months, 1 year, 2 years, 3 years
measure: Radiographic Findings: Number of Participants With Absence of Radiolucency
timeFrame: 3 months, 1 year, 2 years
measure: Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration
timeFrame: 3 months, 1 year, 2 years
measure: Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes
timeFrame: 3 months, 1 year, and 2 years
measure: Implant Survivorship Kaplan-Meier Estimate
timeFrame: Postoperatively, up to 3 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
city: Tucker
country: United States
facility: Emory University
state: Georgia
city: Annapolis
country: United States
facility: Luminis Health
state: Maryland
city: Baltimore
country: United States
facility: Rubin Institute for Advanced Orthopedics, Sinai Hospital
state: Maryland
city: Reno
country: United States
facility: Reno Orthopaedic Clinic Foundation
state: Nevada
city: Philadelphia
country: United States
facility: University of Pennsylvania, Department of Orthopaedic Surgery
state: Pennsylvania
city: Austin
country: United States
facility: St. David's Center for Hip and Knee Replacement
state: Texas
city: Houston
country: United States
facility: INOV8 Healthcare
state: Texas
Study officials:
References: