Survivorship and Outcomes of Robotic-Arm Assisted Medial Unicompartmental Knee Arthroplasty

September 10, 2018 updated by: St. Helena Hospital Coon Joint Replacement Institute
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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 ten year follow up. Study participants will also be asked about their level of satisfaction with their knee function following their robotic-arm assisted Unicompartmental Arthroplasty.

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Saint Helena, California, United States, 94574
        • St. Helena Hospital Coon Joint Replacement Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients over 21 years of age who required a primary robotic-arm assisted medial unicompartmental arthroplasty.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients with revisions
Time Frame: 10 year after surgery
To determine the revision rate in this patient population
10 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients with revisions
Time Frame: 2 years after surgery
To determine the revision rate in this patient population
2 years after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients with revisions
Time Frame: 5 years after surgery
To determine the revision rate in this patient popluation
5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Helena Hospital Coon Joint Replacement Institute

Collaborators

Stryker Orthopaedics

Investigators

  • Principal Investigator: Thomas Coon, MD, St. Helena Hospital Coon Joint Replacement Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

April 1, 2026

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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