R3® Acetabular System in Patients With Degenerative Hip Disease

NCT01407029 | Completed

• 1 other identifier: R3H01
• Study Type: observational
• Target: 158
• Locations: 2 countries
• Sites: 8

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events

  Post Operative - 5 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (8)

Orthopedic Center of Vero Beach

Vero Beach, Florida, 32960, United States

Location

Midwest Orthopedics at Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Washington University Orthopedics

St Louis, Missouri, 63110, United States

Location

Ortho Carolina

Charlotte, North Carolina, 28207, United States

Location

Novant Health Pinnacle Orthopedics

Salisbury, North Carolina, 28144, United States

Location

Concordia Hip and Knee Institute

Winnipeg, Manitoba, R2K 2M9, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

London Health Science Center

London, Ontario, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 1, 2011
• Study Start: October 1, 2009
• Primary Completion: March 14, 2017
• Study Completion: March 14, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (5)