R3® Acetabular System in Patients With Degenerative Hip Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01407029
First received: August 6, 2010
Last updated: April 23, 2014
Last verified: April 2014
  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: Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3® Acetabular System in Patients With Degenerative Hip Disease

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    All perioperative and postoperative device-related and surgical adverse events will be recorded during this study.


Estimated Enrollment: 158
Study Start Date: October 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407029

Locations
United States, Florida
Richard Steinfeld
Vero Beach, Florida, United States, 32960
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

No publications provided

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01407029     History of Changes
Other Study ID Numbers: R3H01
Study First Received: August 6, 2010
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014