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

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.

Study Overview

• Status: Terminated
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Wedge Insert; Other: Flat Insert

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • TRIA Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wedge Insert; Patients will receive a wedge insert	Other: Wedge Insert
Placebo Comparator: Flat insert; Patients will receive a flat insert	Other: Flat Insert

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

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: University of Minnesota; Minnesota Medical Foundation

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: September 29, 2014
• First Submitted That Met QC Criteria: September 29, 2014
• First Posted (Estimate): October 1, 2014

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 1405M50501