Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 30 - 100 |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | December 2016 |
This study is looking at the efficacy of a sloped insole in patients with knee
osteoarthritis. Regularly wearing a sloped insole over the course of one year will result in
a wider joint space by x-ray in 60% of the subjects, a significant decrease in knee pain,
decreased use of over the counter analgesics, and a clinically important improvement in the
Womac pain and stiffness scale.
osteoarthritis. Regularly wearing a sloped insole over the course of one year will result in
a wider joint space by x-ray in 60% of the subjects, a significant decrease in knee pain,
decreased use of over the counter analgesics, and a clinically important improvement in the
Womac pain and stiffness scale.
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
We found this trial at
1
site
Bloomington, Minnesota 55431
Principal Investigator: Marc A Tompkins, MD
Phone: 952-806-5329
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