Study Stopped
Low enrollment.
Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Aug 2014
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
September 20, 2019
CompletedSeptember 20, 2019
February 1, 2017
2.8 years
September 29, 2014
January 18, 2019
August 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
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
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
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
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
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 Outcomes (2)
Kellgren and Lawrence Classification of Osteoarthritis of Knee
Baseline
Kellgren and Lawrence Classification of Osteoarthritis of Knee
6 months
Study Arms (2)
Wedge Insert
EXPERIMENTALPatients will receive a wedge insert
Flat insert
PLACEBO COMPARATORPatients will receive a flat insert
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HealthPartners Institutelead
- University of Minnesotacollaborator
- Minnesota Medical Foundationcollaborator
Study Sites (1)
TRIA Orthopaedic Center
Bloomington, Minnesota, 55431, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Megan Reams
- Organization
- TRIA Orthopaedic Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2014
First Posted
October 1, 2014
Study Start
August 1, 2014
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
September 20, 2019
Results First Posted
September 20, 2019
Record last verified: 2017-02