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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
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and 12 months
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 moreTrial 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.
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Who is running the clinical trial?
Apos Medical and Sports Technology Ltd.Industry Sponsor
6 Previous Clinical Trials
532 Total Patients Enrolled
4 Trials studying Osteoarthritis
334 Patients Enrolled for Osteoarthritis
Geisinger ClinicLead Sponsor
149 Previous Clinical Trials
1,885,985 Total Patients Enrolled
1 Trials studying Osteoarthritis
300 Patients Enrolled for Osteoarthritis
Apos Medical Assets Ltd. (AMA)UNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My pain level is at least moderate, scoring 5 or more.I have been diagnosed with a mental health condition like depression or anxiety in the last 3 months.I have had balance issues, including more than 2 falls, dizziness leading to falls, or I use a walking aid.I had major knee surgery, but it was more than 6 months ago.I have had knee pain from arthritis for at least 6 months.My knee X-rays show I have moderate arthritis.I have not had corticosteroid injections in my knees in the last 6 weeks.My insurance covers Apos treatment.I am between 45 and 80 years old.I am a man or a woman not currently pregnant.My pain in areas other than my knee is worse than in my knee.I have a history of inflammatory rheumatic disease.
Research Study Groups:
This trial has the following groups:- Group 1: AposHealth
- Group 2: Total Knee Replacement (TKR)
- Group 3: Post TKR traditional physical therapy (PT) and AposHealth
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04732962 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate number of individuals who have opted to join this clinical experiment?
"Affirmative. The clinicaltrials.gov website shows that this medical trial is actively searching for participants, having been posted on July 22nd 2021 and last updated November 22nd 2022. It requires 150 individuals to be recruited from two separate sites."
Answered by AI
Does this scientific experiment consider elderly individuals as participants?
"For this particular trial, only patients between the ages of 45 and 80 are eligible to participate. For applicants younger than 18 years old or older than 65, there exist 27 and 433 separate clinical trials respectively."
Answered by AI
Is my eligibility sufficient to qualify me for this medical study?
"This clinical trial seeks to enrol 150 individuals aged 45-80 who suffer from osteoarthritis of the knee. Other criteria include a self-reported moderate pain score, willingness and capability to read and sign an English language informed consent form, gender (male or non-pregnant female), X-ray evidence of Kellgren & Lawrence Grade 2 OA of the knee, and a score between 1-3 on the American Society of Anesthesiologists Physical Status Classification System."
Answered by AI
Are there still vacancies for participants in this research endeavor?
"Current information on clinicaltrials.gov confirms that enrollment is currently open for this trial, which was initially listed on July 22nd 2021 and last updated November 22nd 2022."
Answered by AI
Who else is applying?
What state do they live in?
New York
Ontario
Pennsylvania
How old are they?
65+
What site did they apply to?
Geisinger Medical Center
Geisinger - Orthopaedics Wilkes-Barre
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
What questions have other patients asked about this trial?
Why did patients apply to this trial?
The pain is effecting my life, my physical and mental health. Please consider me.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Average response time
- < 1 Day
Most responsive sites:
- Geisinger - Orthopaedics Wilkes-Barre: < 24 hours
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