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

Sponsor
Medacta USA (Industry)
Overall Status
Completed
CT.gov ID
NCT02912351
Collaborator
(none)
24
1
61.9
0.4

Study Details

Study Description

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 Phase
  • Other: Patient record review, Radiographs, and questionaires.

Study Design

Study Type:
Observational
Actual Enrollment :
24 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 :
Jan 1, 2017
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Mar 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Total Knee Society Scores (KSS) [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 [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 [Minimum 2 years post surgery]

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

  3. Complication Assessment [minimum 2 years post surgery]

    by reviewing Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saint Alphonsus Medical Group Boise Idaho United States 83706

Sponsors and Collaborators

  • Medacta USA

Investigators

  • Study Director: Mukesh Ahuja, MBBS, MS, Medacta USA, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medacta USA
ClinicalTrials.gov Identifier:
NCT02912351
Other Study ID Numbers:
  • K102437-01
First Posted:
Sep 23, 2016
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Keywords provided by Medacta USA
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022