Clinical trial NCT04732962: Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement
Official title: The Effect of a Biomechanical Footwear as a Non-invasive Alternative to Total Knee Replacement and as an Additional Rehabilitation Regimen Postoperatively
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Apos Medical and Sports Technology Ltd.
First posted: 2021-02-01
Enrollment: 150
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: pain: Numerical Pain Rating Scale
timeFrame: 12 months
Secondary outcomes:
measure: Veterans RAND 12 Health Survey (VR-12) physical component score
timeFrame: 3, 6, and 12 months
measure: Koos Jr
timeFrame: 3, 6, and 12 months
measure: pain: Numerical Pain Rating Scale
timeFrame: 3 and 6 months
measure: Step length (left and right)
timeFrame: 6 and 12 months
measure: Single limb support (SLS): % gait cycle (left and right)
timeFrame: 6 and 12 months
measure: Gait velocity
timeFrame: 6 and 12 months
measure: Symmetry index (SI) for step length
timeFrame: 6 and 12 months
measure: Symmetry index (SI) for single limb support (SLS)
timeFrame: 6 and 12 months
measure: Decay rate in AposTherapy group
timeFrame: 12 months
measure: Pain medication intake
timeFrame: 3, 6, and 12 months
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger - Orthopaedics Wilkes-Barre
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Michael Suk, MD
role: PRINCIPAL_INVESTIGATOR
References: