Osteoarthritis
Conditions
Keywords
Total Knee Arthroplasty, Total Knee Replacement, Revision Knee Arthroplasty
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.
Interventions
OTHERPatient record review, Radiographs, and questionaires.
KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction
Sponsors
Medacta USA
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed