Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee

Not Applicable

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Wedge Insert	Wedge Insert	Patients will receive a wedge insert
Flat insert	Flat Insert	Patients will receive a flat insert

Primary Outcome Measures

Name	Time	Method
Patient Reported Function and Pain	12 months	Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.

Secondary Outcome Measures

Name	Time	Method
Kellgren and Lawrence Classification of Osteoarthritis of Knee	6 months	X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).