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Clinical Outcomes of Joint Arthroplasty

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.
 
ClinicalTrials.gov Identifier: NCT03668691
Recruitment Status : Active, not recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
St. Helena Hospital Coon Joint Replacement Institute

Brief Summary:
The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Device: Robotic-arm assisted partial knee arthroplasty

Detailed Description:
The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.

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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Outcomes of Joint Arthroplasty
Study Start Date : July 2011
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Robotic-arm assisted partial knee arthroplasty
    Robotic-arm assisted medial unicompartmental knee arthroplasty, lateral unicompartmental knee arthroplasty, bicompartmental knee arthroplasty, patellofemoral knee arthroplasty implants. A robotic arm assisted unicompartmental or bicompartmental knee arthroplasty procedure to replace the medial or lateral and /or patellofemoral compartments of the knee.


Primary Outcome Measures :
  1. % of patients with Revisions [ Time Frame: 10 years after surgery ]
    To assess the revision rate of this patient population


Secondary Outcome Measures :
  1. Patient satisfaction rate [ Time Frame: 10 years after surgery ]
    To assess level of patient satisfaction using a questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients over 21 years of age who require a primary robotic-arm assisted partial knee replacement.
Criteria

Inclusion Criteria:

  • All patients over 21 years of age who require a primary robotic-arm assisted unicompartmental knee arthroplasty or bicompartmental knee arthroplasty. These patients will have failed non-operative management of their joint disease and are candidates for partial joint replacement because of pain and stiffness that interferes with their performances or normal daily activities.

Exclusion Criteria:

  • Patient had an active infection
  • Onlay implants were implanted without bone cement
  • Patient does not have enough bone stock to allow for insertion and fixation of the components
  • Patient does not have sufficient soft tissue integrity to allow for stability
  • Patient has a neurological or muscular deformity that did not allow for control of the knee
  • Patient will be excluded from participation in the study if they are cognitively unable to answer study questions
  • Pregnant women are excluded.

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): NCT03668691


Locations
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United States, California
St. Helena Hospital Coon Joint Replacement Institute
Saint Helena, California, United States, 94574
Sponsors and Collaborators
St. Helena Hospital Coon Joint Replacement Institute
Stryker Orthopaedics
Investigators
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Principal Investigator: Thomas Coon, MD St. Helena Hospital Coon Joint Replacement Institute
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Responsible Party: St. Helena Hospital Coon Joint Replacement Institute
ClinicalTrials.gov Identifier: NCT03668691    
Other Study ID Numbers: 002
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by St. Helena Hospital Coon Joint Replacement Institute:
osteoarthritis
medial unicompartmental
lateral unicompartmental
bicompartmental
patellofemoral
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases