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Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Knee arthroplasty
Sponsored by
Coxa, Hospital for Joint Replacement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee arthroplasty, working-age, patient related outcome measures

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 65 or less and
  • Scheduled for either TKA or unicondylar knee arthroplasty (UKA)

Exclusion Criteria:

  • rheumatoid arthritis or other inflammatory diseases
  • unwilling to provide informed consent
  • physical, mental, or neurological conditions that could comprise the patient´s ability and compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson's disease, multiple sclerosis (MS), etc.)
  • known sensitivity to materials in the devices.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    working age patients

    Arm Description

    Prospective cohort of 250 patients.

    Outcomes

    Primary Outcome Measures

    Effectiveness of contemporary knee arthroplasty in working-age patients
    PROMs

    Secondary Outcome Measures

    Full Information

    First Posted
    July 26, 2017
    Last Updated
    July 27, 2017
    Sponsor
    Coxa, Hospital for Joint Replacement
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03233620
    Brief Title
    Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients
    Official Title
    Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients: a Prospective Study With 2-year Follow-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2012 (Actual)
    Primary Completion Date
    October 30, 2014 (Actual)
    Study Completion Date
    November 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Coxa, Hospital for Joint Replacement

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of our study was to assess the effectiveness of contemporary knee arthroplasty in working-age patients (< 65 years) by conducting a prospective cohort study with 2-year follow up. Outcomes were measured comprehensively using various patient-reported outcome measures (PROMs) to provide information on the effect of knee arthroplasty on pain, satisfaction, physical activity, activities of daily living, and quality of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    knee arthroplasty, working-age, patient related outcome measures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    250 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    working age patients
    Arm Type
    Other
    Arm Description
    Prospective cohort of 250 patients.
    Intervention Type
    Other
    Intervention Name(s)
    Knee arthroplasty
    Intervention Description
    Effectiveness of knee arthroplasty surgery.
    Primary Outcome Measure Information:
    Title
    Effectiveness of contemporary knee arthroplasty in working-age patients
    Description
    PROMs
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 65 or less and Scheduled for either TKA or unicondylar knee arthroplasty (UKA) Exclusion Criteria: rheumatoid arthritis or other inflammatory diseases unwilling to provide informed consent physical, mental, or neurological conditions that could comprise the patient´s ability and compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson's disease, multiple sclerosis (MS), etc.) known sensitivity to materials in the devices.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34353317
    Citation
    Leppanen S, Niemelainen M, Huhtala H, Eskelinen A. Mild knee osteoarthritis predicts dissatisfaction after total knee arthroplasty: a prospective study of 186 patients aged 65 years or less with 2-year follow-up. BMC Musculoskelet Disord. 2021 Aug 5;22(1):657. doi: 10.1186/s12891-021-04543-8.
    Results Reference
    derived

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    Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients

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