Status:
TERMINATED
Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
University of Minnesota
Minnesota Medical Foundation
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
30-100 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02254473
Start Date
August 1 2014
End Date
June 1 2017
Last Update
September 20 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
TRIA Orthopaedic Center
Bloomington, Minnesota, United States, 55431