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Study of Patient Outcomes 5 Years After Partial Knee Replacement

Sponsor
Athens Orthopedic Clinic, P.A. (Other)
Overall Status
Completed
CT.gov ID
NCT01620892
Collaborator
Arthrex, Inc. (Industry)
159
Enrollment
1
Location
34
Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study seeks to evaluate the condition of patients 5 years after having undergone partial knee replacement for localized osteoarthritis of the knee. Participating patients will voluntarily undergo detailed evaluation of clinical and radiologic outcomes 5 years after surgery. The aims of the study are to describe the survivorship of the prostheses and the clinical results of patients, and to elucidate and describe the natural history disease of the untreated knee joint compartments after a partial replacement. Patients who were operated by the principal investigator 5 years previously will be invited to participate. The study is observational in nature; there is no element of experimentation or test of an intervention.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    159 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Outcomes of Patients With Unicompartmental Arthritis of the Knee Five Years After Treatment With Partial Knee Replacement
    Study Start Date :
    Jun 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2015
    Actual Study Completion Date :
    Apr 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Unicondylar knee replacement

    This is a non-intervational, retrospective, observational study of a case series cohort of patients who received a particular surgical operation during a specified time period.

    Outcome Measures

    Primary Outcome Measures

    1. Time to revision of the partial total knee prosthesis [5 to 7 years after original implantation]

      Eligible participants are invited to enroll into this observational study after the 5-year anniversary of the index primary knee replacement procedure. The participant will be evaluated once to determine whether the original implant is in situ, or has been revised. Method of determination will include self-report of the participant, medical records review/verification, and radiographic examination of the prosthesis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All individuals who have undergone unicondylar knee replacement of a single tibio-femoral compartment using iBalance prosthesis (Arthrex, Inc, Lakeland Florida) under the care of the principal investigator between December, 2006 and December, 2008 will be invited to participate in the study.
    Exclusion Criteria:
    • There are no restrictions to inclusion in the study based on surgical or medical criteria; however, individuals who are pregnant, incarcerated, less than 18 years of age, or unable to give valid informed consent on their own behalf will be excluded from the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Athens Orthopedic Clinic, P.A. Athens Georgia United States 30606

    Sponsors and Collaborators

    • Athens Orthopedic Clinic, P.A.
    • Arthrex, Inc.

    Investigators

    • Principal Investigator: Ormonde M Mahoney, MD, Athens Orthopedic Clinic, P.A.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ormonde M. Mahoney, MD, Principal Investigator, Orthopedic Surgeon, Athens Orthopedic Clinic, P.A.
    ClinicalTrials.gov Identifier:
    NCT01620892
    Other Study ID Numbers:
    • AOC-OM-Arthrex-001
    First Posted:
    Jun 15, 2012
    Last Update Posted:
    Jan 10, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Ormonde M. Mahoney, MD, Principal Investigator, Orthopedic Surgeon, Athens Orthopedic Clinic, P.A.
    unicondylar knee arthroplasty
    partial knee replacement
    Additional relevant MeSH terms:
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Jan 10, 2019