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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912351
• Other study ID #: K102437-01
• Status: Completed
• Start date: January 2017
• Est. completion date: March 2022

Study information

• Verified date: March 2022
• Source: Medacta USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Patient record review, Radiographs, and questionaires.
KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction

Locations

Country	Name	City	State
United States	Saint Alphonsus Medical Group	Boise	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
Medacta USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Knee Society Scores (KSS)	Total Knee Society Score questionnaire to assess Patient satisfaction and Patient expectations and objective knee scores.	Minimum 2 years post surgery
Secondary	Radiographic Analysis	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.	Minimum 2 years post surgery
Secondary	Patient Satisfaction	Assessed with a Likert scale questionnaire for satisfaction of treatment outcome.	Minimum 2 years post surgery
Secondary	Complication Assessment	by reviewing Adverse Events	minimum 2 years post surgery