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R3® Acetabular System in Patients With Degenerative Hip Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01407029
First Posted: August 1, 2011
Last Update Posted: April 26, 2017
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.
Information provided by (Responsible Party):
Smith & Nephew, Inc.
  Purpose
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.

Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3® Acetabular System in Patients With Degenerative Hip Disease

Resource links provided by NLM:


Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 months, 1-5 years ]
    The objective of this study is to establish the safety and effectiveness of the R3 Acetabular System in primary total hip replacement.


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Post Operative - 5 years ]
    All perioperative and postoperative device-related and surgical adverse events will be recorded during this study.


Enrollment: 158
Actual Study Start Date: October 2009
Study Completion Date: March 14, 2017
Primary Completion Date: March 14, 2017 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This clinical study can fulfill its objectives only if appropriate subjects are enrolled. All relevant medical and non-medical conditions should be taken into consideration when deciding whether a particular patient is suitable.
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
  Contacts and Locations
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): NCT01407029


Locations
United States, Florida
Orthopedic Center of Vero Beach
Vero Beach, Florida, United States, 32960
United States, Illinois
Midwest Orthopedics at Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Missouri
Washington University Orthopedics
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Ortho Carolina
Charlotte, North Carolina, United States, 28207
Novant Health Pinnacle Orthopedics
Salisbury, North Carolina, United States, 28144
Canada, Manitoba
Concordia Hip and Knee Institute
Winnipeg, Manitoba, Canada, R2K 2M9
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
London Health Science Center
London, Ontario, Canada
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
Principal Investigator: Richard McCalden, MD London Health Science Centre-University Hospital London Ontario
Principal Investigator: Colin Burnell, MD Concordia Hospital, Winnipeg, Canada
Principal Investigator: James Comadoll, MD Ro Medical Orthopedics, Salisbury NC
Principal Investigator: Richard Steinfeld, MD Orthopaedic Center of Vero Beach, Vero Beach, FL
Principal Investigator: Craig Della Valle, MD Rush University Medical Center
Principal Investigator: John Masonis, MD OrthoCarolina Research Institute
Principal Investigator: Ryan Nunley, MD Washington University Orthopedics
Principal Investigator: Michael Dunbar, MD Halifax Infirmary
  More Information

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01407029     History of Changes
Other Study ID Numbers: R3H01
First Submitted: August 6, 2010
First Posted: August 1, 2011
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases