A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
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.
Condition or disease
Other: Patient record review, Radiographs, and questionaires.
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
Study Start Date :
Estimated Primary Completion Date :
Estimated Study Completion Date :
Resource links provided by the National Library of Medicine
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.
Secondary Outcome Measures :
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.
Patient Satisfaction [ Time Frame: Minimum 2 years post surgery ]
Assessed with a Likert scale questionnaire for satisfaction of treatment outcome.
Complication Assessment [ Time Frame: minimum 2 years post surgery ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
For patients that had received the treatment modality, GMK Revision Knee System and are at least 2 years (24 months) out from surgery.
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
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