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

HealthPartners Institute1 site in 1 country12 target enrollmentAugust 2014

ConditionsKnee Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: HealthPartners Institute
Enrollment: 12
Locations: 1
Primary Endpoint: Patient Reported Function and Pain
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

June 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

HealthPartners Institute

Responsible Party

Sponsor

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 knee
•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

Outcomes

Primary Outcomes

Patient Reported Function and Pain

Time Frame: 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.