Osteoarthritis, KneeNCT04732962
Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement
A study testing AposHealth and Total Knee Replacement (TKR) in people with Osteoarthritis, Knee, run by Geisinger Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- AposHealth and Total Knee Replacement (TKR)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jul 2021to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Kenneth Sams, 570-214-4806, orthoresearch@geisinger.edu
- Recruiting
Geisinger - Orthopaedics Wilkes-Barre
Wilkes-Barre, Pennsylvania, 18702
Kenneth Sams, 570-214-4806, MSKIresearch@geisinger.edu
About this study
Official title: The Effect of a Biomechanical Footwear as a Non-invasive Alternative to Total Knee Replacement and as an Additional Rehabilitation Regimen Postoperatively
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- AposHealth, Total Knee Replacement (TKR)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AposHealthDevice
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.
Total Knee Replacement (TKR)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| AposHealth | Experimental | 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. Receives: Device: AposHealth |
| Total Knee Replacement (TKR) | Active comparator | 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. Receives: Procedure: Total Knee Replacement (TKR) |
| Post TKR traditional physical therapy (PT) and AposHealth | Experimental | 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. Receives: Device: AposHealth; Procedure: Total Knee Replacement (TKR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain: Numerical Pain Rating Scale
score range: worst 0 - 10 best
Measured: 12 months
Secondary outcomes (10)
Veterans RAND 12 Health Survey (VR-12) physical component score
patient's overall perspective of their physical health; worst 15 - 63 best
Measured: 3, 6, and 12 months
Koos Jr
short form of knee injury and osteoarthritis outcome questionnaire; worst 0 - 100 best
Measured: 3, 6, and 12 months
pain: Numerical Pain Rating Scale
score range: worst 0 - 10 best
Measured: 3 and 6 months
Step length (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 for step length (in centimeters).
Measured: 6 and 12 months
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.
Measured: 6 and 12 months
Gait velocity
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 velocity (meter/second).
Measured: 6 and 12 months
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.
Measured: 6 and 12 months
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.
Measured: 6 and 12 months
Decay rate in AposTherapy group
Number of patients assigned to AposTherapy only group who schedule a TKR before end of study period
Measured: 12 months
Pain medication intake
Self-reported daily total milligrams of analgesic medication consumed
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start22 Jul 2021
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Apos Medical and Sports Technology Ltd.
- Responsible party
- Principal investigator, Michael Suk, MD, JD, MPH, MBA, FACS, Geisinger Clinic
- Investigators
- Michael Suk, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732962
- Sponsor's protocol ID
- 2020-0935
- Status last verified
- Sep 2024
- First submitted
- 26 Jan 2021
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Biomechanical Footwear as a Non-invasive Alternative to Total Knee Replacement and as an Additional Rehabilitation Regimen Postoperatively
- ClinicalTrials.gov ID
- NCT04732962
- Acronym / sponsor ID
- 2020-0935
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Apos Medical and Sports Technology Ltd.
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AposHealth | Experimental | Device: AposHealthFollowing 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. |
| Total Knee Replacement (TKR) | Active comparator | Procedure: Total Knee Replacement (TKR)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. |
| Post TKR traditional physical therapy (PT) and AposHealth | Experimental | Device: AposHealth, Procedure: Total Knee Replacement (TKR)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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AposHealthAposHealth 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. | Device | AposHealth, Post TKR traditional physical therapy (PT) and AposHealth |
| 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. | Procedure or surgery | Post TKR traditional physical therapy (PT) and AposHealth, Total Knee Replacement (TKR) |
Primary outcome
pain: Numerical Pain Rating Scale
Time frame: 12 months
score range: worst 0 - 10 best
10 secondary outcomes
Veterans RAND 12 Health Survey (VR-12) physical component score
Time frame: 3, 6, and 12 months
Koos Jr
Time frame: 3, 6, and 12 months
pain: Numerical Pain Rating Scale
Time frame: 3 and 6 months
Step length (left and right)
Time frame: 6 and 12 months
Single limb support (SLS): % gait cycle (left and right)
Time frame: 6 and 12 months
Gait velocity
Time frame: 6 and 12 months
Symmetry index (SI) for step length
Time frame: 6 and 12 months
Symmetry index (SI) for single limb support (SLS)
Time frame: 6 and 12 months
Decay rate in AposTherapy group
Time frame: 12 months
Pain medication intake
Time frame: 3, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Suk, MD principal investigator
Geisinger Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AposHealth and Total Knee Replacement (TKR) in people with Osteoarthritis, Knee, run by Geisinger Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Suk, MD (570-271-6541, orthoresearch@geisinger.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain: Numerical Pain Rating Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.