R3® Acetabular System in Patients With Degenerative Hip Disease

NCT ID: NCT01407029

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2017-03-14

Brief Summary

This is a prospective, non-randomized, consecutive series, multicenter clinical study that will include patients who will have total hip replacement with the R3 Acetabular System.

Detailed Description

The study design was selected to assess the safety and effectiveness profile of the R3 Acetabular System in patients with degenerative joint disease requiring primary total hip replacement. A non¬-randomized, consecutive series of up to 158 patients will be enrolled, and a maximum of 8 sites will participate in the study. Each site is allowed to enroll up to 22 patients. When 158 patients are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. The clinical data from this study will be compared with a historical control. The study will include follow up through 5 years.

Conditions

Osteoarthritis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patient is of legal age to consent and skeletally mature.
• Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, and dysplasia/DDH)
• 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.
• The patient will be available for follow-up throughout the duration of the study.

Exclusion Criteria

• Patient has active infection or sepsis (treated or untreated)
• Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
• Patient is pregnant or plans to become pregnant during the course of the study Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
• Patient has inflammatory joint disease (e.g. rheumatoid arthritis)
• Patient has known moderate to severe renal insufficiency.
• Patient has a known or suspected metal sensitivity.
• Patient is immunosuppressed or receiving high doses of corticosteroids.
• Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.
• Patient has BMI >40.
• Patient is a prisoner

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard McCalden, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Science Centre-University Hospital London Ontario

Colin Burnell, MD

Role: PRINCIPAL_INVESTIGATOR

Concordia Hospital, Winnipeg, Canada

James Comadoll, MD

Role: PRINCIPAL_INVESTIGATOR

Ro Medical Orthopedics, Salisbury NC

Richard Steinfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Center of Vero Beach, Vero Beach, FL

Craig Della Valle, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

John Masonis, MD

Role: PRINCIPAL_INVESTIGATOR

OrthoCarolina Research Institute

Ryan Nunley, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University Orthopedics

Michael Dunbar, MD

Role: PRINCIPAL_INVESTIGATOR

Halifax Infirmary

Locations

Orthopedic Center of Vero Beach

Vero Beach, Florida, United States

Midwest Orthopedics at Rush University Medical Center

Chicago, Illinois, United States

Washington University Orthopedics

St Louis, Missouri, United States

Ortho Carolina

Charlotte, North Carolina, United States

Novant Health Pinnacle Orthopedics

Salisbury, North Carolina, United States

Concordia Hip and Knee Institute

Winnipeg, Manitoba, Canada

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

London Health Science Center

London, Ontario, Canada

Countries

United States; Canada

Other Identifiers

R3H01

Identifier Type: -

Identifier Source: org_study_id