← Back to Search

Behavioural Intervention

Biomechanical Footwear for Knee Osteoarthritis

N/A
Recruiting
Led By Michael Suk, MD
Research Sponsored by Geisinger Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least a moderate NPRS pain score at baseline (≥5)
Symptomatic uni- or bilateral OA of the knee for at least six months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, and 12 months
Awards & highlights

Study Summary

This trial will assess AposHealth, a new biomechanical treatment, as an alternative to current treatments for patients with knee osteoarthritis.

Who is the study for?
This trial is for men and women aged 45-80 with knee osteoarthritis, who've had symptoms for at least six months. They must have a certain level of pain and be able to understand and sign the consent form in English. It's not for those with severe balance issues, BMI over 40, recent steroid injections in the knees, major past knee surgeries (except arthroscopy), more severe non-knee pain, inflammatory diseases or recent mental health conditions.Check my eligibility
What is being tested?
The study tests AposHealth as an alternative to Total Knee Replacement (TKR) surgery for knee osteoarthritis patients and as a post-operative tool after TKR. AposHealth is a home-based biomechanical treatment designed to improve joint function without surgery.See study design
What are the potential side effects?
Since AposHealth is non-invasive focusing on biomechanics rather than medication or surgery, side effects may include muscle soreness or discomfort from new movements or adjustments in walking patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My pain level is at least moderate, scoring 5 or more.
Select...
I have had knee pain from arthritis for at least 6 months.
Select...
My knee X-rays show I have moderate arthritis.
Select...
I am between 45 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Decay rate in AposTherapy group
Gait velocity
Koos Jr
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Post TKR traditional physical therapy (PT) and AposHealthExperimental Treatment2 Interventions
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.
Group II: AposHealthExperimental Treatment1 Intervention
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.
Group III: Total Knee Replacement (TKR)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Apos Medical and Sports Technology Ltd.Industry Sponsor
6 Previous Clinical Trials
553 Total Patients Enrolled
4 Trials studying Osteoarthritis
334 Patients Enrolled for Osteoarthritis
Geisinger ClinicLead Sponsor
149 Previous Clinical Trials
1,883,303 Total Patients Enrolled
1 Trials studying Osteoarthritis
300 Patients Enrolled for Osteoarthritis
Apos Medical Assets Ltd. (AMA)UNKNOWN

Media Library

AposHealth (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04732962 — N/A
Osteoarthritis Research Study Groups: AposHealth, Total Knee Replacement (TKR), Post TKR traditional physical therapy (PT) and AposHealth
Osteoarthritis Clinical Trial 2023: AposHealth Highlights & Side Effects. Trial Name: NCT04732962 — N/A
AposHealth (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04732962 — N/A
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04732962 — N/A
~28 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top