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.
Study Type
OBSERVATIONAL
Enrollment
20
Nagasaki University
Nagasaki, Japan
Osaka Koseinenkin Hospital
Osaka, Japan
Hashiba Orthopaedic Clinic
Toyama, Japan
Toyama Municipal Hospital
Toyama, Japan
Function of the knee
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 24 months
Patient-evaluated function of the knee and quality of life
Oxford-12-item knee score, WOMAC (as calculated from the KOOS)
Time frame: 6 months, 12 months, 24 months
Clinician-evaluated function of the knee
Japanese Orthopaedic Association (JOA) score
Time frame: 6 months, 12 months, 24 months
Health-related quality of life
Short Form-36 (SF-36)
Time frame: 6 months, 12 months, 24 months
Range of motion (ROM)
Time frame: 6 months, 12 months, 24 months
Local and general pain
Visual Analogue Scale (VAS)
Time frame: 6 months, 12 months, 24 months
Possibility and duration of the Japanese sitting style
Time frame: 6 months, 12 months, 24 months
Return to sport activities
Time frame: 6 months, 12 months, 24 months
Utilization
Length of hospital stay
Time frame: up to hospital discharge
Evaluation of degenerated and regenerated cartilage
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ICRS and Outerbridge / Koshino)
Time frame: intraoperative and after 2 years
Radiological parameters
Kellgren-Lawrence classification, joint space narrowing, tibial slope, tibia vara
Time frame: 6 months, 12 months, 24 months
Complications
Complications due to injections, complications due to heat therapy, complications due to medication (NSAIDs)
Time frame: 6 months, 12 months, 24 months
Anatomical alignment
Femoro tibial angle (FTA)
Time frame: 6 months, 12 months, 24 months