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Clinical Outcomes With Apex (OK) Knee System

This study is currently recruiting participants.
Verified December 2012 by Spokane Joint Replacement Center
Sponsor:
Information provided by (Responsible Party):
David F. Scott, MD, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier:
NCT01367938
First received: May 22, 2011
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

This study tracks the clinical outcomes associated with the OK knee Total Knee Arthroplasty (TKA) system.


Condition
Osteoarthritis of the Knee

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Outcomes With Omni Apex (OK) Knee System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spokane Joint Replacement Center:

Primary Outcome Measures:
  • Clinical outcomes [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Clinical outcomes to include overall success, revision rate, adverse events, clinical score (Knee Society Score), range of motion, radiographic findings.


Estimated Enrollment: 56
Study Start Date: November 2009
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
OK knee
OK Knee group

Detailed Description:

This study tracks the clinical outcomes associated with the OK knee TKA system, including Knee Society Scores, range of motion and stability, overall radiographic and clinical success, and adverse events.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Adult patients undergoing total knee replacement

Criteria

Inclusion Criteria:

  • see protocol
  • Adults with DJD of the knee
  • undergoing primary total knee arthroplasty
  • aged 20-80 years old
  • BMI less than 40
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367938

Locations
United States, Washington
Spokane Joint Replacement Center Recruiting
Spokane, Washington, United States, 99218
Contact: David F Scott, MD     509-466-6393     dfscott@orthospecialtyclinic.com    
Principal Investigator: David F Scott, MD            
Sponsors and Collaborators
Spokane Joint Replacement Center
Investigators
Principal Investigator: David F Scott, MD Spokane Joint Replacement Center
  More Information

No publications provided

Responsible Party: David F. Scott, MD, PI, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier: NCT01367938     History of Changes
Other Study ID Numbers: SJRC-OK
Study First Received: May 22, 2011
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Spokane Joint Replacement Center:
Osteoarthritis
Total Knee Replacement

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

ClinicalTrials.gov processed this record on May 22, 2013