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Trial record 12 of 2651 for:    ( Map: Idaho, United States )

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

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ClinicalTrials.gov Identifier: NCT02912351
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteoarthritis Other: Patient record review, Radiographs, and questionaires.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : January 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
For patients that had received the treatment modality, GMK Revision Knee System and are at least 2 years (24 months) out from surgery.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912351


Contacts
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Contact: Mukesh Ahuja, MBBS, MS 312-548-9968 Mahuja@medacta.us.com

Locations
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United States, Idaho
Saint Alphonsus Medical Group Recruiting
Boise, Idaho, United States, 83706
Contact: Dennis McGee, MD    208-367-3330      
Principal Investigator: Dennis McGee, MD         
Sponsors and Collaborators
Medacta USA
Investigators
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Study Director: Mukesh Ahuja, MBBS, MS Medacta USA, Inc.

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Responsible Party: Medacta USA
ClinicalTrials.gov Identifier: NCT02912351     History of Changes
Other Study ID Numbers: K102437-01
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Keywords provided by Medacta USA:
Total Knee Arthroplasty
Total Knee Replacement
Revision Knee Arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases