Overview

This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments wedge insert, flat insert
Sponsor HealthPartners Institute
Collaborator University of Minnesota - Clinical and Translational Science Institute
Start date August 2014
End date January 2017
Trial size 80 participants
Trial identifier NCT02254473, 1405M50501

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Patients will receive a wedge insert
wedge insert
(Placebo Comparator)
Patients will receive a flat insert
flat insert

Primary Outcomes

Measure
Patient reported function and pain
time frame: Baseline
Patient reported function and pain
time frame: 6 weeks
Patient reported function and pain
time frame: 3 months
Patient reported function and pain
time frame: 6 months
Patient reported function and pain
time frame: 9 months
Patient reported function and pain
time frame: 12 months

Secondary Outcomes

Measure
Imaging
time frame: Baseline
Imaging
time frame: 6 months

Eligibility Criteria

Male or female participants from 30 years up to 100 years old.

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

Additional Information

Official title Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by HealthPartners Institute.