Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement

Официальное название

The Effect of a Biomechanical Footwear as a Non-invasive Alternative to Total Knee Replacement and as an Additional Rehabilitation Regimen Postoperatively

Обзор

Osteoarthritis (OA), the most common type of arthritis, affects more than 32.5 million adults in the United States. It is also among the most expensive condition to treat when joint replacement surgery is required. Although biomechanics plays an important role in OA disease, the non-surgical treatment options addressing biomechanics are scarce with limited effect. AposHealth is the fist biomechanical treatment that was shown to have a significant short-term effect on patients with knee OA. The main objectives of this study are: 1. To assess AposHealth, a non-invasive home-based biomechanical treatment, as an alternative treatment for patients who are eligible for Total Knee Replacement (TKR). 2. To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.

Подробное описание

Osteoarthritis (OA), the most common type of arthritis, affects more than 32.5 million adults in the United States. It is also among the most expensive condition to treat when joint replacement surgery is required. Future projections of the prevalence of OA predict an increase in prevalence, mainly due to the aging of the population and obesity.

Total knee replacement (TKR) is the end-stage solution for patients with knee OA. The total annual cost of arthritis in the U.S. in 2013 reached over $300 billion. Expenditure is expected to grow significantly in response to the increase in prevalence and the projected number of TKRs.

Successful and beneficial non-invasive treatment options for knee OA are limited. More specifically, although biomechanics plays an important role in OA disease, the non-surgical treatment options addressing biomechanics are scarce with limited effect. AposHealth is the fist biomechanical treatment that was shown to have a significant short-term effect on patients with knee OA.

The main objectives of this study are:

1. To assess AposHealth, a non-invasive home-based biomechanical treatment, as an alternative treatment for patients who are eligible for TKR. 2. To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.

Вмешательства

• Устройство AposHealth
  AposHealth is comprised of a unique footwear (Apos device) and uses two convex pods called "Pertupods", which are screwed into the plantar surface of the sole so that a person walks on these pods. A trained Apos therapist calibrates the devices. The location of the pods is adjusted according to the treatment methodology, depending on the needed effect on unloading the knee and with the purpose of potentially alleviating pain immediately.
• Процедура Total Knee Replacement (TKR)
  A total knee replacement occurs when a diseased or damaged knee joint is totally replaced with an artificial joint called an implant. The implant consists of high-grade metal and plastic components that fuse to the resurfaced bone. It is designed to move like a healthy human joint.

Первичные конечные точки

• pain: Numerical Pain Rating Scale [Срок оценки: 12 months]

Вторичные конечные точки (10)

• Veterans RAND 12 Health Survey (VR-12) physical component score [Срок оценки: 3, 6, and 12 months]
• Koos Jr [Срок оценки: 3, 6, and 12 months]
• pain: Numerical Pain Rating Scale [Срок оценки: 3 and 6 months]
• Step length (left and right) [Срок оценки: 6 and 12 months]
• Single limb support (SLS): % gait cycle (left and right) [Срок оценки: 6 and 12 months]
• Gait velocity [Срок оценки: 6 and 12 months]
• Symmetry index (SI) for step length [Срок оценки: 6 and 12 months]
• Symmetry index (SI) for single limb support (SLS) [Срок оценки: 6 and 12 months]
• Decay rate in AposTherapy group [Срок оценки: 12 months]
• Pain medication intake [Срок оценки: 3, 6, and 12 months]

Критерии участия

Критерии включения

• Men or non-pregnant women
• Between ages 45 and 80, inclusive
• ACR clinical criteria for OA of the knee
• Symptomatic uni- or bilateral OA of the knee for at least six months
• Radiological criteria: X-rays showing tibiofemoral knee osteoarthritis defined as at least Kellgren and Lawrence Grade 2
• At least a moderate NPRS pain score at baseline (≥5)
• Score of 1-3 based on the American Society of Anesthesiologists Physical Status Classification System
• Willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure

Критерии исключения

• Body Mass Index (BMI) > 40
• History of an inflammatory rheumatic disease
• Non-knee musculoskeletal pain that is more severe than the knee pain
• Corticosteroids injections in the knees in the previous 6 weeks
• Previous major surgery to the knee such as osteotomy, hemiprosthesis, unilateral total joint replacement excluding knee arthroscopy > 6 months
• Patients with Geisinger Health Plan insurance for whom Apos is a covered treatment
• Patients with a recent history (<3 months) of a mental health condition, such as depression or anxiety
• Problems with balance (>2 unexplained falls within the last 12 months; experiencing regular dizziness that has caused a trip or fall; using a walking aid to get around such as a rollator, cane, walker)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Geisinger Medical Center — Danville
• Geisinger - Orthopaedics Wilkes-Barre — Wilkes-Barre

Идентификаторы

NCT: NCT04732962 · 2020-0935

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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