A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis

March 30, 2022 updated by: Medacta USA

A Post-Market, Single-Center, Retrospective Study to Collect Clinical Outcomes and Safety Data From Patients Who Have Undergone Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis and Are at Least 2 Years Past Surgery

This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years post-treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

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
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Medical Group

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

For patients that had received the treatment modality, GMK Revision Knee System and are at least 2 years (24 months) out from surgery.

Description

Inclusion Criteria:

  • Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to any study procedure.
  • Patients with ability to understand and provide written authorization for use and disclosure of personal health information
  • Patients must be willing to comply with the post-operative evaluation schedule.
  • Patients underwent either a primary or revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure).
  • Patients must have received a GMK Revision component
  • Patients must be at minimum 2 year (24 months) post-treatment
  • The operation was performed or supervised by the investigator.
  • No age limit criteria

Exclusion Criteria:

  • History of alcoholism
  • Currently on chemotherapy or radiation therapy
  • Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
  • History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
  • History of chronic pain issues for reasons other than knee pain
  • Women that are pregnant

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Knee Society Scores (KSS)
Time Frame: Minimum 2 years post surgery
Total Knee Society Score questionnaire to assess Patient satisfaction and Patient expectations and objective knee scores.
Minimum 2 years post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Analysis
Time Frame: Minimum 2 years post surgery
Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration and the presence and progression of radiolucent line between the prosthesis, bone and cement.
Minimum 2 years post surgery
Patient Satisfaction
Time Frame: Minimum 2 years post surgery
Assessed with a Likert scale questionnaire for satisfaction of treatment outcome.
Minimum 2 years post surgery
Complication Assessment
Time Frame: minimum 2 years post surgery
by reviewing Adverse Events
minimum 2 years post surgery

Collaborators and Investigators

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

Sponsor

Medacta USA

Investigators

  • Study Director: Mukesh Ahuja, MBBS, MS, Medacta USA, Inc.

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

January 1, 2017

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K102437-01

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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