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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03056534
Other study ID # 16-4565-10
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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