Clinical Outcomes of Joint Arthroplasty

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

250

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 require a primary robotic-arm assisted partial knee replacement.

Description

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.

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: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients with Revisions
Time Frame: 10 years after surgery
To assess the revision rate of this patient population
10 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction rate
Time Frame: 10 years after surgery
To assess level of patient satisfaction using a questionnaire.
10 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

July 1, 2011

Primary Completion (Anticipated)

March 1, 2027

Study Completion (Anticipated)

March 1, 2027

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 12, 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

  • 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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