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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Patient record review, Radiographs, and questionaires.

KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes