NCT02912351CompletedNot Applicable
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
Medacta USA1 site in 1 country24 target enrollmentStarted: January 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Total Knee Society Scores (KSS)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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 Outcomes
- Radiographic Analysis(Minimum 2 years post surgery)
- Patient Satisfaction(Minimum 2 years post surgery)
- Complication Assessment(minimum 2 years post surgery)
Investigators
Study Sites (1)
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