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Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients

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ClinicalTrials.gov Identifier: NCT03233620
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Coxa, Hospital for Joint Replacement

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Knee arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients: a Prospective Study With 2-year Follow-up
Actual Study Start Date : March 1, 2012
Actual Primary Completion Date : October 30, 2014
Actual Study Completion Date : November 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
working age patients
Prospective cohort of 250 patients.
Other: Knee arthroplasty
Effectiveness of knee arthroplasty surgery.




Primary Outcome Measures :
  1. Effectiveness of contemporary knee arthroplasty in working-age patients [ Time Frame: 2 years ]
    PROMs



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier: NCT03233620     History of Changes
Other Study ID Numbers: R11178
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Coxa, Hospital for Joint Replacement:
knee arthroplasty
working-age
patient related outcome measures

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases