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Completed

NCT Number: NCT02912351

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

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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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Alphonsus Medical Group

Boise, Idaho, 83706, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient record review, Radiographs, and questionaires.

Other

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

Primary outcomes

  1. Total Knee Society Scores (KSS)

    Time frame: Minimum 2 years post surgery

    Total Knee Society Score questionnaire to assess Patient satisfaction and Patient expectations and objective knee scores.

Secondary outcomes

  1. Radiographic Analysis

    Time frame: 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.

  2. Patient Satisfaction

    Time frame: Minimum 2 years post surgery

    Assessed with a Likert scale questionnaire for satisfaction of treatment outcome.

  3. Complication Assessment

    Time frame: minimum 2 years post surgery

    by reviewing Adverse Events

Sponsors and collaborators

Lead sponsor

Medacta USA

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2016
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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