Clinical trial NCT02254473: Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee
Official title: Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee
Osteoarthritis
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Minnesota Medical Foundation
First posted: 2014-10-01
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Patient Reported Function and Pain
timeFrame: Baseline
measure: Patient Reported Function and Pain
timeFrame: 6 weeks
measure: Patient Reported Function and Pain
timeFrame: 3 months
measure: Patient Reported Function and Pain
timeFrame: 6 months
measure: Patient Reported Function and Pain
timeFrame: 9 months
measure: Patient Reported Function and Pain
timeFrame: 12 months
Secondary outcomes:
measure: Kellgren and Lawrence Classification of Osteoarthritis of Knee
timeFrame: Baseline
measure: Kellgren and Lawrence Classification of Osteoarthritis of Knee
timeFrame: 6 months
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center
state: Minnesota
Study officials:
References: