Survivorship and Outcomes of Robotic-Arm Assisted Medial Unicompartmental Knee Arthroplasty
1 other identifier
observational
133
1 country
1
Brief Summary
The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay Unicompartmental knee arthroplasty implants at two, five and tem year follow up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 28, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedSeptember 13, 2018
September 1, 2018
14.5 years
September 28, 2016
September 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% of patients with revisions
To determine the revision rate in this patient population
10 year after surgery
Secondary Outcomes (1)
% of patients with revisions
2 years after surgery
Other Outcomes (1)
% of patients with revisions
5 years after surgery
Interventions
Robotic-arm assisted medical MCK implant system to replace the medial compartment of the knee.
Eligibility Criteria
All patients over 21 years of age who required a primary robotic-arm assisted medial unicompartmental arthroplasty.
You may qualify if:
- All patients over 21 years of age who underwent primary robotic-arm assisted unicompartmental arthroplasty and received a medial MCK onlay implant and are at least 24 months post-operative.
- Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written consent, patient has verbally consented to study participations.
- Patient willing to comply with follow up.
You may not qualify if:
- Patient will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health related quality of life forms.
- Patient had active infection
- Medial MCK onlay 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Helena Hospital Coon Joint Replacement Institute
St. Helena, California, 94574, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Coon, MD
St. Helena Hospital Coon Joint Replacement Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2016
First Posted
September 13, 2018
Study Start
October 1, 2011
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
September 13, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share