M17.0 M17.1 M17.2 M17.3 M17.4 M17.5
Conditions
Interventions
Group 1: Valgus knee unloader brace, Unloader One OTS (Össur Deutschland GmbH), the orthosis should be used for a minimum of 6 hours per day over the course of the study (6 month).
Group 2: Valgus fo
Sponsors
Otto Bock HealthCare Deutschland GmbH
Eligibility
Sex/Gender
All
Age
35 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults aged 35 years and older years suffering from medial OA. Medial OA is defined as pain located at the medial joint space in combination with radiological signs of OA (Grade 1 or higher) [2]. The radiological signs of OA will be assessed on whole leg x rays using the classification stated by Kellgren and Lawrence [8] (Grade 0-IV).
Exclusion criteria
Exclusion criteria: 1. No knowledge of the German language, 2. pain which is not caused by medial OA, 3. lateral OA grade I and more, 4. no varus malalignement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures are subjective assessments of pain at rest, with walking, and sports activity, reported on a numerical scale (0 to 100) [2] at baseline, at 8 weeks, 6 months and 1 year. This parameter was used for the sample size calculation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective assessment of recovery using a seven-point Likert scale The seven-point (completely recovered, strongly recovered, significant improvement, moderate improvement, little improvement, slightly recovered, worse than ever) Likert scale used in the present study was used previously by Van Linschoten et al. [10] to study the effect of supervised physiotherapy on patients with a patellofemoral pain syndrome. Patients were deemed to have recovered if they rated themselves fully recovered or strongly recovered, whereas those who rated themselves slightly recovered to worse than ever were deemed not to have recovered. This threshold was used to dichotomize perceived recovery into two clear categories: “recovered” and “not recovered”. Time points: at 8 weeks, 6 months and 1 year 2. Knee osteoarthritis outcome score (KOOS) The validated German version of the KOOS is self-explanatory and consists of five subscales; pain, symptoms, sports/recreational activities, activities of daily living, and function [11]. Standardized answer options are given (five Likert boxes), and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale [11,12]. A total score has not been validated and is not recommended [11]. Responders to the treatment will be defined in accordance with the OMERACT/OARSI set of responder criteria [13]. According to these criteria a responder is a patient having an improvement of more than 20% compared with the baseline score for pain (VAS) and function (KOOS). Time points: at 8 weeks, 6 months and 1 year 3. Skin irritations All patients are instructed that skin irritations can occur at sites where the pads of the brace press against the skin. In this case the patients should take a photo of the skin irritation and contact the study center. 4. Compliance The patients should mark in a notebook how long the orthosis was used per day. This book should be s | — |
Countries
Germany, Switzerland
Contacts
Public ContactSarah Schröder
Otto Bock HealthCare Deutschland GmbH
Outcome results
None listed