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

Primary Purpose

Osteoarthritis, Knee

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AposHealth

Total Knee Replacement (TKR)

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Geisinger Medical CenterRecruiting
Geisinger - Orthopaedics Wilkes-BarreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

AposHealth

Total Knee Replacement (TKR)

Post TKR traditional physical therapy (PT) and AposHealth

Arm Description

Following the initial consultation and calibration of the Apos device in the clinic, the patients will receive from his therapist a home-based treatment plan. This usually includes wearing the device for about 20 minutes with about 20% of weight-bearing (patient is instructed to wear the Apos and just be with the device and go about his/her daily routine). A gradual increase in usage time is prescribed reaching up to 60 min wear time with about 40% weight-bearing. Patients are requested to return to follow-up (FU) appointments after 1, 3, 6, 9 and 12 months. In addition, patients will have a remote FU after 1-week to confirm they use AposHealth as advised. During the follow-up appointment, re-assessment of clinical outcomes and gait patterns are performed and the calibration of the Apos device is adjusted as needed. The treatment plan is adjusted, and patients are encouraged to continue to wear the device regularly at home.

Patients will undergo TKR according to Geisinger's policy, guidelines and care protocol. The study baseline visit will occur 6 weeks postoperative for TKR groups.

Patients who have had a knee replacement and were assigned to the traditional PT+ AposHealth group will follow Geisinger post-operative rehab protocol and will also receive AposHealth and follow the rehabilitation protocol. AposHealth will start six weeks post-op and will continue for 12 months. Patients will receive AposHealth similar to the non-invasive group, i.e., will have an initial evaluation (IE) and calibration of the Apos device, have a remote FU after one week from IE and in-clinic FUs at 1, 3 6, 9 and 12 months.

Outcomes

Primary Outcome Measures

pain: Numerical Pain Rating Scale

score range: worst 0 - 10 best

Secondary Outcome Measures

Veterans RAND 12 Health Survey (VR-12) physical component score

patient's overall perspective of their physical health; worst 15 - 63 best

Koos Jr

short form of knee injury and osteoarthritis outcome questionnaire; worst 0 - 100 best

pain: Numerical Pain Rating Scale

score range: worst 0 - 10 best

Step length (left and right)

Single limb support (SLS): % gait cycle (left and right)

A computerized mat is used to measure spatiotemporal gait parameters (ProtoKinetics Zeno™ Walkway Gait Analysis System). The gait mat detects pressure data during gait, during balance, and additional movement protocols. During the gait test, all patients are asked to walk barefoot at a self-selected speed. Patients walk 3 meters before and after the walkway mat to allow sufficient acceleration and deceleration time outside the measurement area. Each gait test included 6 walks and the mean value of the 6 walks is calculated. A single gait cycle is defined from heel strike of one limb to the next heel strike (of the mane limb). A gait cycle is comprised of 2 phases: Stance (limb on the ground) and swing (limb swings forward). The stance phase is divided into SLS (one limb is on the ground while the other limb swings forward) and double limb support (both feet are on the ground). The absolute time of SLS will be converted to percent of gait cycle for standardization purposes.

Gait velocity

Symmetry index (SI) for step length

A computerized mat is used to measure spatiotemporal gait parameters (ProtoKinetics Zeno™ Walkway Gait Analysis System). The gait mat detects pressure data during gait, during balance, and additional movement protocols. During the gait test, all patients are asked to walk barefoot at a self-selected speed. Patients walk 3 meters before and after the walkway mat to allow sufficient acceleration and deceleration time outside the measurement area. Each gait test included 6 walks and the mean value of the 6 walks is calculated for step length (in centimeters). Temporal distance (T-D) symmetry is used to calculate Symmetry Index (SI) for step length using the formula: (involved-uninvolved)/[(involved+uninvolved)/2)] x 100. SI value of zero represents perfect symmetry and up to 5% difference between limbs is considered normal.

Symmetry index (SI) for single limb support (SLS)

A computerized mat is used to measure spatiotemporal gait parameters (ProtoKinetics Zeno™ Walkway Gait Analysis System). Each gait test included 6 walks and the mean value is calculated. A single gait cycle is defined from heel strike of one limb to the next heel strike (of the mane limb). A gait cycle is comprised of 2 phases: Stance (limb on the ground) and swing (limb swings forward). The stance phase is divided into SLS (one limb is on the ground while the other limb swings forward) and double limb support (both feet are on the ground). The absolute time of SLS will be converted to % of gait cycle for standardization purposes. Temporal distance (T-D) symmetry is used to calculate Symmetry Index (SI) for SLS (% gait cycle) using the formula: (involved-uninvolved)/[(involved+uninvolved)/2)] x 100. SI value of zero represents perfect symmetry and up to 5% difference between limbs is considered normal.

Decay rate in AposTherapy group

Number of patients assigned to AposTherapy only group who schedule a TKR before end of study period

Pain medication intake

Self-reported daily total milligrams of analgesic medication consumed

Full Information

NCT ID

NCT04732962

First Posted

January 26, 2021

Last Updated

May 24, 2023

Sponsor

Geisinger Clinic

Collaborators

Apos Medical Assets Ltd. (AMA)

1. Study Identification

Unique Protocol Identification Number

NCT04732962

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 22, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Geisinger Clinic

Collaborators

Apos Medical Assets Ltd. (AMA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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: To assess AposHealth, a non-invasive home-based biomechanical treatment, as an alternative treatment for patients who are eligible for Total Knee Replacement (TKR). 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: To assess AposHealth, a non-invasive home-based biomechanical treatment, as an alternative treatment for patients who are eligible for TKR. To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AposHealth

Arm Type

Experimental

Arm Description

Arm Title

Total Knee Replacement (TKR)

Arm Type

Active Comparator

Arm Description

Patients will undergo TKR according to Geisinger's policy, guidelines and care protocol. The study baseline visit will occur 6 weeks postoperative for TKR groups.

Arm Title

Post TKR traditional physical therapy (PT) and AposHealth

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

AposHealth

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Total Knee Replacement (TKR)

Intervention Description

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.

Primary Outcome Measure Information:

Title

pain: Numerical Pain Rating Scale

Description

score range: worst 0 - 10 best

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Veterans RAND 12 Health Survey (VR-12) physical component score

Description

patient's overall perspective of their physical health; worst 15 - 63 best

Time Frame

3, 6, and 12 months

Title

Koos Jr

Description

short form of knee injury and osteoarthritis outcome questionnaire; worst 0 - 100 best

Time Frame

3, 6, and 12 months

Title

pain: Numerical Pain Rating Scale

Description

score range: worst 0 - 10 best

Time Frame

3 and 6 months

Title

Step length (left and right)

Description

Time Frame

6 and 12 months

Title

Single limb support (SLS): % gait cycle (left and right)

Description

Time Frame

6 and 12 months

Title

Gait velocity

Description

Time Frame

6 and 12 months

Title

Symmetry index (SI) for step length

Description

A computerized mat is used to measure spatiotemporal gait parameters (ProtoKinetics Zeno™ Walkway Gait Analysis System). The gait mat detects pressure data during gait, during balance, and additional movement protocols. During the gait test, all patients are asked to walk barefoot at a self-selected speed. Patients walk 3 meters before and after the walkway mat to allow sufficient acceleration and deceleration time outside the measurement area. Each gait test included 6 walks and the mean value of the 6 walks is calculated for step length (in centimeters). Temporal distance (T-D) symmetry is used to calculate Symmetry Index (SI) for step length using the formula: (involved-uninvolved)/[(involved+uninvolved)/2)] x 100. SI value of zero represents perfect symmetry and up to 5% difference between limbs is considered normal.

Time Frame

6 and 12 months

Title

Symmetry index (SI) for single limb support (SLS)

Description

Time Frame

6 and 12 months

Title

Decay rate in AposTherapy group

Description

Number of patients assigned to AposTherapy only group who schedule a TKR before end of study period

Time Frame

12 months

Title

Pain medication intake

Description

Self-reported daily total milligrams of analgesic medication consumed

Time Frame

3, 6, and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Suk, MD

Phone

570-271-6541

orthoresearch@geisinger.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kenneth Sams

Phone

570-214-4806

kbsams@geisinger.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Suk, MD

Organizational Affiliation

Geisinger Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Geisinger Medical Center

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kenneth Sams

Phone

570-214-4806

orthoresearch@geisinger.edu

Facility Name

Geisinger - Orthopaedics Wilkes-Barre

City

Wilkes-Barre

State/Province

Pennsylvania

ZIP/Postal Code

18702

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kenneth Sams

Phone

570-214-4806

MSKIresearch@geisinger.edu

12. IPD Sharing Statement

Learn more about this trial

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

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