A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis
Study Details
Study Description
Brief Summary
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 | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Total Knee Society Scores (KSS) [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 [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 [Minimum 2 years post surgery]
Assessed with a Likert scale questionnaire for satisfaction of treatment outcome.
- Complication Assessment [minimum 2 years post surgery]
by reviewing Adverse Events
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Patients with ability to understand and provide written authorization for use and disclosure of personal health information
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Patients must be willing to comply with the post-operative evaluation schedule.
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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).
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Patients must have received a GMK Revision component
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Patients must be at minimum 2 year (24 months) post-treatment
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The operation was performed or supervised by the investigator.
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No age limit criteria
Exclusion Criteria:
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History of alcoholism
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Currently on chemotherapy or radiation therapy
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Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
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History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
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History of chronic pain issues for reasons other than knee pain
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Women that are pregnant
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Saint Alphonsus Medical Group | Boise | Idaho | United States | 83706 |
Sponsors and Collaborators
- Medacta USA
Investigators
- Study Director: Mukesh Ahuja, MBBS, MS, Medacta USA, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K102437-01