Clinical trial: Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee (NCT02254473)

Eligibility criteria:
Inclusion Criteria:

          -  Adult patients 30 years or older with medial compartment knee Osteoarthritis
             (unilateral) and Grade 4 Kellgren-Lawrence39 radiographic changes presenting for
             treatment of knee pain.

          -  Range of motion knee-flexion beyond 100 degrees and not lacking more than 15 degrees
             of extension.

          -  Subtalar and forefoot motion permitting foot/ankle eversion with weight bearing.

          -  Sufficient shoe toe box height to allow space for the insole and therefore comfort and
             compliance.

          -  Passive laxity of medial capsule and collateral ligament by knee extension test.

        Exclusion Criteria:

          -  All other forms of knee arthritis other than OA.

          -  Knee Instability- medial pseudo-opening of greater than grade 1 or detectable
             Anterior-posterior instability.

          -  Less than Grade 4 Kellgren-Lawrence radiographic changes in the medial compartment of
             the knee39.

          -  Grade 2 or greater Kellgren-Lawrence radiographic39 involvement of the patellofemoral
             or lateral compartment.

          -  Inadequate knee range of motion

          -  Balance problems requiring the use of a walker or wheel chair - ambulation with aid

          -  Diabetics with peripheral neuropathy

          -  Knee surgery within the past year

          -  Intraarticular steroid injection or visco supplementation within 6 months

          -  Stiff subtalar or forefoot joints - clinical test

          -  Inadequate shoe toe box depth to accommodate the test or control inserts

          -  Charcot joint

          -  Fixed contracture of the medial capsule and/or collateral ligament- clinical test
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 100 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment