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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03233620
Other study ID # R11178
Secondary ID
Status Completed
Phase N/A
First received July 26, 2017
Last updated July 27, 2017
Start date March 1, 2012
Est. completion date November 1, 2016

Study information

Verified date July 2017
Source Coxa, Hospital for Joint Replacement
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date November 1, 2016
Est. primary completion date October 30, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Knee arthroplasty
Effectiveness of knee arthroplasty surgery.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Coxa, Hospital for Joint Replacement

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of contemporary knee arthroplasty in working-age patients PROMs 2 years
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