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

August 6, 2010
April 23, 2014
October 2009
October 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01407029 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
R3® Acetabular System in Patients With Degenerative Hip Disease
A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3® Acetabular System in Patients With Degenerative Hip Disease

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Osteoarthritis
Not Provided
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
158
December 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01407029
R3H01
No
Smith & Nephew, Inc.
Smith & Nephew, Inc.
Not Provided
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
Smith & Nephew, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP