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Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental 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: NCT03668704
Recruitment Status : Active, not recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
St. Helena Hospital Coon Joint Replacement Institute

Brief Summary:
The purpose of the study is to determine the clinical outcomes and survivorship of robotic-arm assisted medial bicompartmental knee arthroplasty at two, five, seven and ten years postoperative.

Condition or disease
Osteoarthritis

Detailed Description:
The purpose of the study is to determine the survivorship, patient satisfaction and clinical outcomes of robotic-arm assisted medial bicompartmental knee arthroplasty using the MCK implant system starting at two years post-operative and continuing for five, seven and ten years post-operative.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty
Study Start Date : April 2013
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine


Group/Cohort
Medial Bicompartmental Knee Arthroplasty
Patient who have received a robotic-arm assisted medial and patellofemoral knee arthroplasty.



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


Secondary Outcome Measures :
  1. % of patients with Revisions [ Time Frame: 2 years after surgery ]
    To determine the revision rate in this patient population


Other Outcome Measures:
  1. % of patients with revisions [ Time Frame: 5 years after surgery ]
    To determine the revision rate in this patient population

  2. % of patients with revisions [ Time Frame: 7 years after surgery ]
    To determine the revision rate in this patient population



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 medial bicompartmental arthroplasty.
Criteria

Inclusion Criteria:

  • All patients over 21 years of age who underwent robotic-arm assisted medial bicompartmental arthroplasty by the investigating surgeon and received MCK implants and are at least 24 months post-operative.
  • Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written signed consent, patient has verbally consented to study participation.
  • Patient is willing to comply with follow up

Exclusion Criteria:

  • Patients will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health quality of life forms.
  • Patient had active infection
  • Implants were implanted without bone cement
  • Patients did not have sufficient bone stock to allow for insertion and fixation of components
  • Patient did not have sufficient soft tissue integrity to allow for stability
  • Patient had a neurological or muscular deformity that did not allow for control of the knee.

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): NCT03668704


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: NCT03668704    
Other Study ID Numbers: 003
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 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
bicompartmental
patellofemoral
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases