R3® Acetabular System in Patients With Degenerative Hip Disease

Osteoarthritis Clinical Trial

Official title:

A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3® Acetabular System in Patients With Degenerative Hip Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407029
• Other study ID #: R3H01
• Status: Completed
• Phase: N/A
• First received: August 6, 2010
• Last updated: April 24, 2017
• Start date: October 2009
• Est. completion date: March 14, 2017

Study information

• Verified date: April 2017
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 14, 2017
• Est. primary completion date: March 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	London Health Science Center	London	Ontario
Canada	Concordia Hip and Knee Institute	Winnipeg	Manitoba
United States	Ortho Carolina	Charlotte	North Carolina
United States	Midwest Orthopedics at Rush University Medical Center	Chicago	Illinois
United States	Washington University Orthopedics	Saint Louis	Missouri
United States	Novant Health Pinnacle Orthopedics	Salisbury	North Carolina
United States	Orthopedic Center of Vero Beach	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness will be measured using the Harris Hip Score (HHS), The HOOS self assessment questionnaire, and radiographic assessment. Radiographic measures consist of radiolucencies, component position changes, and bony changes.	The objective of this study is to establish the safety and effectiveness of the R3 Acetabular System in primary total hip replacement.	3 months, 1-5 years
Secondary	Adverse Events	All perioperative and postoperative device-related and surgical adverse events will be recorded during this study.	Post Operative - 5 years