Clinical trial NCT01407029: R3® Acetabular System in Patients With Degenerative Hip Disease
Official title: A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3® Acetabular System in Patients With Degenerative Hip Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
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.
timeFrame: 3 months, 1-5 years
Secondary outcomes:
measure: Adverse Events
timeFrame: Post Operative - 5 years
Other outcomes:
Locations:
city: Vero Beach
country: United States
facility: Orthopedic Center of Vero Beach
state: Florida
city: Chicago
country: United States
facility: Midwest Orthopedics at Rush University Medical Center
state: Illinois
city: Saint Louis
country: United States
facility: Washington University Orthopedics
state: Missouri
city: Charlotte
country: United States
facility: Ortho Carolina
state: North Carolina
city: Salisbury
country: United States
facility: Novant Health Pinnacle Orthopedics
state: North Carolina
city: Winnipeg
country: Canada
facility: Concordia Hip and Knee Institute
state: Manitoba
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Science Center
state: Ontario
Study officials:
affiliation: London Health Science Centre-University Hospital London Ontario
name: Richard McCalden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Concordia Hospital, Winnipeg, Canada
name: Colin Burnell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ro Medical Orthopedics, Salisbury NC
name: James Comadoll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic Center of Vero Beach, Vero Beach, FL
name: Richard Steinfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Craig Della Valle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OrthoCarolina Research Institute
name: John Masonis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University Orthopedics
name: Ryan Nunley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Halifax Infirmary
name: Michael Dunbar, MD
role: PRINCIPAL_INVESTIGATOR
References: