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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Patient record review, Radiographs, and questionaires.


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Patient record review, Radiographs, and questionaires.|KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Knee Society Scores (KSS) | 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 | 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 | Assessed with a Likert scale questionnaire for satisfaction of treatment outcome. | Minimum 2 years post surgery | 
| Complication Assessment | by reviewing Adverse Events | minimum 2 years post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Total Knee Replacement, Revision Knee Arthroplasty