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NCT01032538 Clinical Trial

Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement

Osteoarthritis Clinical Trial

Official title:
Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement - A Prospective Longitudinal Study With Repetitive Measures of KOOS in 100 Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01032538
Other study ID # TKN-002
Secondary ID 19441 (NSD)
Status Completed
Phase
First received
Last updated
Start date November 2003
Est. completion date February 2017

Study information
Verified date November 2023
Source Martina Hansen's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.

Description:

The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest. Thats it!

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date February 2017
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - patients with medial knee osteoarthritis - admitted for unicondylar knee replacement - age 50-80 years Exclusion criteria - rheumatoid arthritis - previous knee infection

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Bærum Sykehus Bærum Akershus
Norway Martina Hansens Hospital Bærum
Norway Akershus University Hospital Lørenskog Akershus

Sponsors (2)
Lead Sponsor Collaborator
Martina Hansen's Hospital South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Knee Injury and Osteoarthritis Outcome Score Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best. Preoperative until 2 years postoperatively
Secondary Range of Motion Preoperative until 2 years postoperatively
Secondary Oxford Knee Score Preoperative until 2 years postoperatively
Secondary UCLA Score Preoperative until 2 years postoperatively
Secondary Knee Injury and Osteoarthritis Outcome Score 10 years postoperatively
Secondary Oxford Knee Score 10 years postoperatively
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