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Clinical Outcomes With Apex (OK) Knee System

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by David F. Scott, MD, Spokane Joint Replacement Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367938
First Posted: June 7, 2011
Last Update Posted: December 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David F. Scott, MD, Spokane Joint Replacement Center
  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:


Further study details as provided by David F. Scott, MD, Spokane Joint Replacement Center:

Primary Outcome Measures:
  • Clinical outcomes [ Time Frame: 5 years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: David F. Scott, MD, PI, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier: NCT01367938     History of Changes
Other Study ID Numbers: SJRC-OK
First Submitted: May 22, 2011
First Posted: June 7, 2011
Last Update Posted: December 13, 2012
Last Verified: December 2012

Keywords provided by David F. Scott, MD, Spokane Joint Replacement Center:
Osteoarthritis
Total Knee Replacement

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