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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02254473
• Other study ID #: 1405M50501
• Status: Terminated
• Phase: N/A
• Start date: August 2014
• Est. completion date: June 2017

Study information

• Verified date: February 2017
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Wedge Insert

• Flat Insert

Locations

Country	Name	City	State
United States	TRIA Orthopaedic Center	Bloomington	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	Minnesota Medical Foundation, University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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