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

Primary Purpose

Knee Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wedge Insert
Flat Insert
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee, Osteoarthritis

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • TRIA Orthopaedic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Wedge Insert

Flat insert

Arm Description

Patients will receive a wedge insert

Patients will receive a flat insert

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
September 29, 2014
Last Updated
August 19, 2019
Sponsor
HealthPartners Institute
Collaborators
University of Minnesota, Minnesota Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02254473
Brief Title
Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee
Official Title
Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment.
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
University of Minnesota, Minnesota Medical Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wedge Insert
Arm Type
Experimental
Arm Description
Patients will receive a wedge insert
Arm Title
Flat insert
Arm Type
Placebo Comparator
Arm Description
Patients will receive a flat insert
Intervention Type
Other
Intervention Name(s)
Wedge Insert
Intervention Type
Other
Intervention Name(s)
Flat Insert
Primary Outcome Measure Information:
Title
Patient Reported Function and Pain
Description
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.
Time Frame
Baseline
Title
Patient Reported Function and Pain
Description
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.
Time Frame
6 weeks
Title
Patient Reported Function and Pain
Description
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.
Time Frame
3 months
Title
Patient Reported Function and Pain
Description
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.
Time Frame
6 months
Title
Patient Reported Function and Pain
Description
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.
Time Frame
9 months
Title
Patient Reported Function and Pain
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Kellgren and Lawrence Classification of Osteoarthritis of Knee
Description
X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).
Time Frame
Baseline
Title
Kellgren and Lawrence Classification of Osteoarthritis of Knee
Description
X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
TRIA Orthopaedic Center
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States

12. IPD Sharing Statement

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

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