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

HealthPartners Institute

Status: Terminated

Conditions: Knee Osteoarthritis

Treatments: Other: Wedge Insert; Other: Flat Insert

Study type: Interventional

Funder types: Other

Identifiers

NCT02254473

1405M50501

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 30 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups, including a placebo group

Wedge Insert

Experimental group

Description:

Patients will receive a wedge insert

Treatment:

Other: Wedge Insert

Flat insert

Placebo Comparator group

Description:

Patients will receive a flat insert

Treatment:

Other: Flat Insert