R3 Delta Ceramic Acetabular System PAS U.S.

Degenerative Joint Disease Clinical Trial

— R3-PAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056534
• Other study ID #: 16-4565-10
• Status: Completed
• Start date: January 17, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

R3 Delta Post-Approval Study U.S.

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 information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis

Intervention

Device:
• R3 Biolox Delta Ceramic Acetabular System
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).

Locations

Country	Name	City	State
United States	Anne Arundel Health System Research Institute	Annapolis	Maryland
United States	St. David's Center for Hip and Knee Replacement	Austin	Texas
United States	Rubin Institute for Advanced Orthopedics, Sinai Hospital	Baltimore	Maryland
United States	Memorial Bone & Joint Research Foundation	Houston	Texas
United States	University of Pennsylvania, Department of Orthopaedic Surgery	Philadelphia	Pennsylvania
United States	Reno Orthopaedic Clinic Foundation	Reno	Nevada
United States	Foundation for Orthopaedic Research and Education	Tampa	Florida
United States	Emory University	Tucker	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall success at 3 years postoperative defined as no component revision	No component revision	3 Years postoperative
Primary	Overall success at 3 years postoperative defined as Modified Harris Hip Score of at least 80 points	Modified Harris Hip Score of at least 80 points	3 Years postoperative
Primary	Overall success at 3 years postoperative no radiographic failure defined as: no radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones	No Radiographic Failure	3 Years postoperative
Primary	Overall success at 3 years postoperative defined as No femoral or acetabular subsidence greater than or equal to 5 mm from baseline	No Radiographic Failure	3 Years postoperative
Primary	Overall success at 3 years postoperative defined as no acetabular cup inclination changes greater than 4 degrees from baseline.	No Radiographic Failure	3 Years postoperative
Secondary	Secondary endpoints include clinical assessments of pain and function using the Modified Hip Harris Score	Assessment of pain and function	3 Years postoperative
Secondary	Secondary endpoints include clinical assessments of radiographic findings	Radiographic Findings	3 Years postoperative
Secondary	Secondary endpoints include clinical assessments of implant survivorship.	Implant survivorship	3 Years postoperative