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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02912351
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Medacta USA
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Mukesh Ahuja, MBBS, MS
Principal Investigator Affiliation Medacta USA, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Saint Alphonsus Medical Group, Boise, Idaho

Status

Recruiting

Address

Saint Alphonsus Medical Group

Boise, Idaho, 83706

Site Contact

Dennis McGee, MD

[email protected]

208-367-3330

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