Osteoarthritis, Knee Clinical Trial
Official title:
A Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee
The primary objective of this registry is to assess the functional outcome measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial unicompartmental osteoarthritis and osteonecrosis of the knee treated conservatively. The aim of the Focused Registry is to complete the data collection and enable a sound analysis for the Tomofix Small size study.
The aim of the Focused Registry is to complete the data collection and enable a sound
analysis for the Tomofix Small size study.
The incidence of knee osteoarthritis (OA) is higher in Japan than in other populations.
Respective prevalences of 47.0 and 70.2% in men and women for Kellgren-Lawrence Grades 2-4
knee OA are reported in Japanese patients aged 60 years and over.
First treatment options are pharmacological (i.e. NSAIDs) and non-pharmacological therapies
(i.e. use of assistive devices, exercises, osteopathy, physical therapy), followed by
injections of hyaluronic acid and other substances. If no such therapies are successful,
surgical treatment options as unicompartmental knee replacement, total knee arthroplasty and
high tibial osteotomy (HTO) are recognized. The discussion of which is the best therapy is
still controversial. HTO may decrease the number of complications compared to total knee
replacement or unicompartmental knee arthroplasty and leave the option for later replacement
surgery.
In this project, patients are included who would be surgically treated with HTO with Tomofix
small based on the investigator's assessment but refuse to have surgical treatment. They will
be treated conservatively and are investigated to serve as reference to an ongoing clinical
study investigating invasive treatment modalities.
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