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

Medacta

Status: Completed

Conditions: Osteoarthritis

Treatments: Other: Patient record review, Radiographs, and questionaires.

Study type: Observational

Funder types: Industry

Identifiers

NCT02912351

K102437-01

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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