TerminatedNCT03153956Updated Mar 24, 2020Results posted

Efficacy of AposTherapy® in Knee OA

An interventional study of Calibrated AposTherapy® and Non-Calibrated Sham Apos Therapy Device in Osteoarthritis, Knee, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-24.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

Why this study was terminated

Halt in funding

From the registry’s dates

Registered 2 years after the study started (first participant enrolled Apr 2015, registered May 2017).

Phase: Not applicable
Study type: Interventional
Enrollment: 77
Allocation: Randomized
Ages: 45 Years to 75 Years
Sex: All

Study summary

A prospective, interventional, randomized, double-arm clinical evaluation study to examine the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the long-term at 12 months post-treatment, with the primary efficacy assessment based on improvement in knee pain score and improvement in function in patients following diagnosis of knee osteoarthritis (OA).

Conditions studied

Osteoarthritis, Knee

Browse trials for

Keywords

AposTherapy® System
Osteoarthritis
Total knee arthroplasties
Degenerative joint disease

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 77 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients suffering from symptomatic unilateral or bilateral knee OA at the medial compartment for at least six months;
Fulfilling the ACR clinical criteria;
Having radiographically assessed OA of the knee with a Kellgren-Lawrence grade more than or equal to grade 2; and,
Having VAS-Pain ≥ 3, on a scale between 0-10.
Patients who have a shoe size between US 4 and US 12

Exclusion criteria

Exclusion Criteria:

Patients suffering from acute septic arthritis.
Patients who received a corticosteroid injection within 3 months of the study.
Patients who received hyaluronic acid (HA) injections within 6 months of the study
Patients suffering from avascular necrosis of the knee.
Patients with a history of knee buckling or recent knee injury.
Patients who have had a joint replacement or other major surgery to the knee, hip or ankle (ipsilateral or contralateral side).
Patients suffering from neuropathic arthropathy.
Patients with an increased tendency to fall.
Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure.
Patients with a history of pathological osteoporotic fracture.
Patients suffering from symptomatic degenerative arthritis in lower limb joints other than the knees.
Patients with referred pain in the knees from primary back or hip joint pain.
Patients with neurological deficits to the lower extremity (ex. foot drop)
Patients whose shoe size is less than US 4 and greater than US 12
Patients who have had arthroscopy within 6 months of the study
Patients with inflammatory arthropathy

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 77 participants (actual)

Study arms

Experimental
Active Treatment Arm
Personally calibrated bio-mechanical device
Device: Calibrated AposTherapy®
Placebo comparator
Control Arm
sham-placebo device (similar shoes without bio-mechanical elements).
Device: Non-Calibrated Sham Apos Therapy Device

Interventions

DeviceCalibrated AposTherapy®
a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.
DeviceNon-Calibrated Sham Apos Therapy Device
The comparator group will receive a non-calibrated sham device.

What researchers measure

Primary outcomes

Western Ontario and McMaster University (WOMAC) Total Score
WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: screening, 3 months, 6 months, 9 months, and 12 months

Secondary outcomes

Visual Analog Score (VAS) Score
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Time frame: 12 Months
Short-Form 36 (SF-36) Total Score
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The survey consists eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100, with lower scores = more disability and higher scores = less disability. Therefore, higher scores represent better health.
Time frame: screening, 3 months, 6 months, 9 months, and 12 months

Results

Posted Mar 24, 2020

Participant flow

Participant flow — Overall Study
Milestone	Active Treatment Arm	Control Arm
Started	39	38
Completed	39	38
Not completed	0	0

Outcome measures

PrimaryWestern Ontario and McMaster University (WOMAC) Total Score

WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Time frame:: screening, 3 months, 6 months, 9 months, and 12 months
Reported as:: Mean · score on a scale

Western Ontario and McMaster University (WOMAC) Total Score
score on a scale	Active Treatment Arm	Control Arm
WOMAC Total score - screen	1062.7 ± 545.96	975.1 ± 580.87
WOMAC Total score - 3 months	548.8 ± 440.22	601.1 ± 467.39
WOMAC Total Score - 6 months	420.2 ± 391.7	524.8 ± 448.83
WOMAC Total Score - 9 months	—	280.2 ± 194.84
WOMAC Total Score - 12 months	396.5 ± 324.99	433 ± 352.32

SecondaryVisual Analog Score (VAS) Score

The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

Time frame:: 12 Months

No measurements were reported for this outcome.

SecondaryShort-Form 36 (SF-36) Total Score

The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The survey consists eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100, with lower scores = more disability and higher scores = less disability. Therefore, higher scores represent better health.

Time frame:: screening, 3 months, 6 months, 9 months, and 12 months
Reported as:: Mean · score on a scale

Short-Form 36 (SF-36) Total Score
score on a scale	Active Treatment Arm	Control Arm
SF-36 total score - screening	55.6 ± 15.03	56.6 ± 16.77
SF-36 total score - 3 months	64.6 ± 16.8	63.0 ± 17.09
SF-36 total score - 6 months	69.7 ± 14.8	68 ± 17.21
SF-36 total score - 9 months	—	74.5 ± 6.37
SF-36 total score - 12 month	71 ± 9.77	66.6 ± 15.38

Adverse events

Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Active Treatment Arm	0/39 (0%)	0/39 (0%)	0/39 (0%)
Control Arm	0/38 (0%)	0/38 (0%)	0/38 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Active Treatment Arm	Control Arm	Total
Mean	62 ± 9	61 ± 8.2	61 ± 8.6

Sex: Female, Male
Sex: Female, Male(Participants)	Active Treatment Arm	Control Arm	Total
Female	27	27	54
Male	12	11	23

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Active Treatment Arm	Control Arm	Total
Count of participants	—	—	0

Study locations

1 site

New York University School of Medicine
New York, New York 10016, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jun 23, 2015

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03153956
Lead sponsor: NYU Langone Health
Responsible party: Sponsor
First posted: May 15, 2017
Start date: Apr 16, 2015
Primary completion: Nov 15, 2018
Completion: Nov 15, 2018
Results posted: Mar 24, 2020
Last update: Mar 24, 2020

Study contacts

Dennis Cardone, DO

principal investigator · NYU Langone Health

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Osteoarthritis→

Other studies from this sponsor

NYU Langone Health

Start the discussion