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

NCT ID: NCT02254473

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-06-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Wedge Insert

Patients will receive a wedge insert

Group Type: EXPERIMENTAL

Wedge Insert

Intervention Type: OTHER

Flat insert

Patients will receive a flat insert

Group Type: PLACEBO_COMPARATOR

Flat Insert

Intervention Type: OTHER

Interventions

Wedge Insert

Intervention Type: OTHER

Flat Insert

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

Minnesota Medical Foundation

OTHER

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TRIA Orthopaedic Center

Bloomington, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1405M50501

Identifier Type: -

Identifier Source: org_study_id