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

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT02912351
• Lead Sponsor: Medacta USA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-23
• Study Start: 2017-01
• Status Verified: 2022-03
• Primary Completion: 2022-03
• Study Completion: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Saint Alphonsus Medical Group; 🇺🇸 Boise, Idaho, United States