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

Study Overview
=================
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.

Official Title
-----------------
Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: Wedge Insert
* Other: Flat Insert


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wedge Insert<br>Patients will receive a wedge insert | Other: Wedge Insert<br> <br> |
| Placebo Comparator: Flat insert<br>Patients will receive a flat insert | Other: Flat Insert<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Function and Pain | 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. | Baseline | 
| Patient Reported Function and Pain | 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. | 6 weeks | 
| Patient Reported Function and Pain | 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. | 3 months | 
| Patient Reported Function and Pain | 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. | 6 months | 
| Patient Reported Function and Pain | 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. | 9 months | 
| Patient Reported Function and Pain | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kellgren and Lawrence Classification of Osteoarthritis of Knee | X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee). | Baseline | 
| Kellgren and Lawrence Classification of Osteoarthritis of Knee | X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee). | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee, Osteoarthritis