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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

Must not have

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)

Patients with Geisinger Health Plan insurance for whom Apos is a covered treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, and 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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My pain level is at least moderate, scoring 5 or more.

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I have had knee pain from arthritis for at least 6 months.

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My knee X-rays show I have moderate arthritis.

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I am between 45 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had balance issues, including more than 2 falls, dizziness leading to falls, or I use a walking aid.

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My insurance covers Apos treatment.

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My pain in areas other than my knee is worse than in my knee.

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I have a history of inflammatory rheumatic disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, and 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Decay rate in AposTherapy group

Gait velocity

Koos Jr

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met