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Trial record 1 of 1 for:    03056534
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R3 Delta Ceramic Acetabular System PAS U.S. (R3-PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056534
Recruitment Status : Active, not recruiting
First Posted : February 17, 2017
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

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

Condition or disease Intervention/treatment
Degenerative Joint Disease Device: R3 Biolox Delta Ceramic Acetabular System

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.

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Study Type : Observational
Actual Enrollment : 189 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders


Intervention Details:
  • 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).


Primary Outcome Measures :
  1. Overall success at 3 years postoperative defined as no component revision [ Time Frame: 3 Years postoperative ]
    No component revision

  2. Overall success at 3 years postoperative defined as Modified Harris Hip Score of at least 80 points [ Time Frame: 3 Years postoperative ]
    Modified Harris Hip Score of at least 80 points

  3. 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 [ Time Frame: 3 Years postoperative ]
    No Radiographic Failure

  4. Overall success at 3 years postoperative defined as No femoral or acetabular subsidence greater than or equal to 5 mm from baseline [ Time Frame: 3 Years postoperative ]
    No Radiographic Failure

  5. Overall success at 3 years postoperative defined as no acetabular cup inclination changes greater than 4 degrees from baseline. [ Time Frame: 3 Years postoperative ]
    No Radiographic Failure


Secondary Outcome Measures :
  1. Secondary endpoints include clinical assessments of pain and function using the Modified Hip Harris Score [ Time Frame: 3 Years postoperative ]
    Assessment of pain and function

  2. Secondary endpoints include clinical assessments of radiographic findings [ Time Frame: 3 Years postoperative ]
    Radiographic Findings

  3. Secondary endpoints include clinical assessments of implant survivorship. [ Time Frame: 3 Years postoperative ]
    Implant survivorship



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056534


Locations
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United States, Florida
Foundation for Orthopaedic Research and Education
Tampa, Florida, United States, 33637
United States, Georgia
Emory University
Tucker, Georgia, United States, 30084
United States, Maryland
Anne Arundel Health System Research Institute
Annapolis, Maryland, United States, 21401
Rubin Institute for Advanced Orthopedics, Sinai Hospital
Baltimore, Maryland, United States, 21215
United States, Nevada
Reno Orthopaedic Clinic Foundation
Reno, Nevada, United States, 89503
United States, Pennsylvania
University of Pennsylvania, Department of Orthopaedic Surgery
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
St. David's Center for Hip and Knee Replacement
Austin, Texas, United States, 78750
Memorial Bone & Joint Research Foundation
Houston, Texas, United States, 77043
Sponsors and Collaborators
Smith & Nephew, Inc.

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03056534    
Other Study ID Numbers: 16-4565-10
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Smith & Nephew, Inc.:
Primary Total Hip Arthroplasty
Non-Inflammatory Arthritis
Degenerative Joint Disease
R3 Delta Ceramic Acetabular Insert
Additional relevant MeSH terms:
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Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases