R3 Delta Ceramic Acetabular System PAS U.S.

NCT03056534 | Completed Results FDA Device

• 1 other identifier: 16-4565-10
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 8

Brief Summary

R3 Delta Post-Approval Study U.S.

Conditions

Degenerative Joint Disease

Keywords

Primary Total Hip Arthroplasty; Non-Inflammatory Arthritis; Degenerative Joint Disease; R3 Delta Ceramic Acetabular Insert

Outcome Measures

Primary Outcomes (7)

• Overall Study Success at 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.)

  3 Years Postoperative

• Component Revisions at 3 Years Postoperative

  Number of participants component revisions identified as "Success" or "Failure" with success defined as no component revision for any reason.

  3 Years Postoperative

• Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points

  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.

  3 Years postoperative

• Overall Radiographic Success at 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

  3 Years Postoperative

• Number of Participants With Absence of Radiolucency at 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

  3 Years postoperative

• Number of Participants With Absence of Femoral Subsidence or Acetabular Migration at 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.

  3 Years postoperative

• Number of Participants With Absence of Acetabular Cup Inclination Changes Greater Than 4 Degrees From Baseline at 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.

  3 Years postoperative

Secondary Outcomes (5)

• 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

• Implant Survivorship Kaplan-Meier Estimate

  Postoperatively, up to 3 years

Interventions

R3 Biolox Delta Ceramic Acetabular System DEVICE

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).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (8)

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33637, United States

Location

Emory University

Tucker, Georgia, 30084, United States

Location

Luminis Health

Annapolis, Maryland, 21401, United States

Location

Rubin Institute for Advanced Orthopedics, Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Reno Orthopaedic Clinic Foundation

Reno, Nevada, 89503, United States

Location

University of Pennsylvania, Department of Orthopaedic Surgery

Philadelphia, Pennsylvania, 19104, United States

Location

St. David's Center for Hip and Knee Replacement

Austin, Texas, 78750, United States

Location

INOV8 Healthcare

Houston, Texas, 77043, United States

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Limitations and Caveats

The impact of the COVID-19 pandemic on participant retention, out of window follow-up visits, and data acquisition due to participants being unable or not willing to undergo study assessments at follow-up visits. Primary outcome analyses were not impacted by COVID-19. Data missing for secondary outcome analyses was low and risks were mitigated by appropriate alternative data collection methods.

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

+44 7811 407089

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 17, 2017
• Study Start: February 7, 2018
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: April 13, 2025
• Results First Posted: April 13, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)