Survivorship and Outcomes of Robotically Assisted Patellofemoral UKA

September 4, 2018 updated by: St. Helena Hospital Coon Joint Replacement Institute
The purpose of the study is to determine the survivorship rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to determine the survivorship rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative.

Study Type

Observational

Enrollment (Anticipated)

40

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
    • Washington
      • Vancouver, Washington, United States, 98686
        • Rebound Orthopedics and Neurosurgery

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

Patients who underwent a primary robotically guided UKA and received an isolated patellofemoral implant.

Description

Inclusion Criteria:

  • Over 21 years of age underwent primary robotically guided UKA and received an isolated patellofemoral implant at least 24 months post operative as of February 2013

Exclusion Criteria:

  • Patient will be excluded from participation in the study if they are cognitively unable to answer study questions.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patellofemoral Knee Arthroplasty
Patient who have received a robotically guided isolated patellofemoral implant.
Device: Robotically guided patellofemoral UKA isolated patellofemoral implants
A robot guided isolated patellofemoral unicompartmental knee arthroplasty procedures to replace only the patellofemoral component of the knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 year survivorship of robotically guided isolated patellofemoral implants.
Time Frame: 10 years after surgery
10 year survivorship of robotically guided isolated patellofemoral implants at 2,5, and 10 year follow up.
10 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 year survivorship of robotically guided isolated patellofemoral implants.
Time Frame: 2 years after surgery
The survivorship rate of robotically guided isolated patellofemoral implants at 2,5, and 10 year.
2 years after surgery
5 year survivorship of robotically guided isolated patellofemoral implants.
Time Frame: 5 years after surgery
The survivorship rate of robotically guided isolated patellofemoral implants at 2,5, and 10 years post operative.
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

Rebound Orthopedics and Neurosurgery

Investigators

  • Study Director: Thomas Coon, MD, St. Helena Hospital Coon Joint Replacement

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

February 1, 2013

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

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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