The objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.
Osteoarthritis (OA) is one of the leading causes of physical disability in the world, affecting a growing portion of the elderly, indeed, it is estimated that 85% of all people over age 60 have some degree of OA. A survey of 2000 French general practitioners indicated that 10% usually prescribe knee orthoses for patients with knee OA. With the increasing importance of non-pharmacological treatment in recommendations for OA, orthoses will increase in use. The use of an offloading knee brace that encompasses the knee has proven to be a safe, cost-efficient treatment option for reducing pain and improving function. It can even delay the need for surgery. The aim of this study is to perform a randomized, prospective, interventional, 3-arm parallel group study to look at the difference in outcome in knee osteoarthritic patient with the use of the new semi-rigid offloading brace versus knee brace comparator versus without orthosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it
The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it
Trauma Orthopedic Surgery Practice Center
Aachen, Friedrich-Wilhelm-Platz 5, Germany
Pain-free walking distance
The evolution of pain-free walking distance evaluated by reporting the distance that the patient can walk without pain.
Time frame: 6 weeks
Knee functional capacity
The evolution of knee functional capacity is evaluated by the Lequesne index completed by the patient at inclusion and six weeks of follow-up (minimum index score 0: None handicap, maximum index score 24: Handicap extremely severe)
Time frame: 6 weeks
Pain on loading
The evolution of pain on loading is measured via a numerical rating scale (NRS) after a thirty-minute walk at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)
Time frame: 6 weeks
Pain at rest
The evolution of pain at rest is measured via a numerical rating scale (NRS) at inclusion and six weeks of follow-up: 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome)
Time frame: 6 weeks
Analgesic consumption
The use of analgesics is collected all along the study via a patient's diary completed by the patient every day and via the physician during the inclusion and the six weeks follow-up visit .
Time frame: 6 weeks
Subjective range of movement
The subjective knee range of movement is assessed qualitatively by having patients rate it as follow: * 'clearly improved', * 'improved', * 'unchanged', * 'deteriorated' * 'clearly deteriorated'.
Time frame: 6 weeks
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Objective range of movement
The objective improvement of knee range of movement is assessed quantitatively by a goniometer (range of movement measure expressed in degrees)
Time frame: 6 weeks
Assessment of Patient's Global Impression of Change (PGI-C)
Patient's opinion on Global Impression of Change about his/her general condition by using the PGIC questionnaire completed at the six weeks follow-up visit by the patient. The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference (better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference
Time frame: 6 weeks
Assessment of compliance
The evaluation of compliance with devices during the duration of the study is reported by the investigator according to the patient's diary completed by the patient each day.
Time frame: 6 weeks
Assessment of patient's satisfaction
The evaluation of patient satisfaction with devices is assessed via a self-questionnaire at the end of the study
Time frame: 6 weeks
Assessment of safety (AE and SAEs)
The safety of the devices is evaluated by the description of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the study and collected by the patient via the patient's diary and the investigator during follow-up visits: * number, * type, * frequency, * intensity, * relationship with the study device
Time frame: 6 weeks