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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254473
Recruitment Status : Terminated (Low enrollment.)
First Posted : October 1, 2014
Results First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
University of Minnesota
Minnesota Medical Foundation
Information provided by (Responsible Party):
HealthPartners Institute

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 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Wedge Insert Other: Flat Insert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee
Study Start Date : August 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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



Primary Outcome Measures :
  1. Patient Reported Function and Pain [ Time Frame: Baseline ]
    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.

  2. Patient Reported Function and Pain [ Time Frame: 6 weeks ]
    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. Patient Reported Function and Pain [ Time Frame: 3 months ]
    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.

  4. Patient Reported Function and Pain [ Time Frame: 6 months ]
    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.

  5. Patient Reported Function and Pain [ Time Frame: 9 months ]
    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. Patient Reported Function and Pain [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Kellgren and Lawrence Classification of Osteoarthritis of Knee [ Time Frame: Baseline ]
    X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).

  2. Kellgren and Lawrence Classification of Osteoarthritis of Knee [ Time Frame: 6 months ]
    X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254473


Locations
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United States, Minnesota
TRIA Orthopaedic Center
Bloomington, Minnesota, United States, 55431
Sponsors and Collaborators
HealthPartners Institute
University of Minnesota
Minnesota Medical Foundation
  Study Documents (Full-Text)

Documents provided by HealthPartners Institute:
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT02254473    
Other Study ID Numbers: 1405M50501
First Posted: October 1, 2014    Key Record Dates
Results First Posted: September 20, 2019
Last Update Posted: September 20, 2019
Last Verified: February 2017
Keywords provided by HealthPartners Institute:
Knee
Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases