A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis
Overview
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.
Full Title of Study: “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 Type
- Study Type: Observational
- Study Design
- Time Perspective: Retrospective
- Study Primary Completion Date: March 2022
Interventions
- Other: Patient record review, Radiographs, and questionaires.
- KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction
Clinical Trial Outcome Measures
Primary Measures
- 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 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
- by reviewing Adverse Events
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Medacta USA
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Mukesh Ahuja, MBBS, MS, Study Director, Medacta USA, Inc.
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