Knee OsteoarthritisNCT02254473

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

A study testing Wedge Insert and Flat Insert in people with Knee Osteoarthritis, run by HealthPartners Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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… Read more about this study

Who is it for?: Ages 30 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Wedge Insert and Flat Insert
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Aug 2014to Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

TRIA Orthopaedic Center
Bloomington, Minnesota, 55431

Other trials in United States

About this study

Conditions: Knee Osteoarthritis
Being tested: Wedge Insert, Flat Insert
Keywords: Knee, Osteoarthritis
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Wedge InsertOther
Flat InsertOther

Study groups in NCT02254473
Study group	Role	What they receive
Wedge Insert	Experimental	Patients will receive a wedge insert Receives: Other: Wedge Insert
Flat insert	Placebo comparator	Patients will receive a flat insert Receives: Other: Flat Insert

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months

Secondary outcomes (2)

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).
Measured: Baseline
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).
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Jun 2017

First posted1 Oct 2014 (estimated)
Study startAug 2014
Primary completionJun 2017
Study completionJun 2017

Why it stopped: Low enrollment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02254473
Sponsor's protocol ID: 1405M50501
Status last verified: Feb 2017
First submitted: 29 Sep 2014
Last updated: 20 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Anti-inflammatory Diet in Osteoarthritis
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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT02254473
Acronym / sponsor ID: 1405M50501
Conditions: Knee Osteoarthritis
Keywords: Knee, Osteoarthritis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low enrollment.
Enrolment: 12 participants (actual)
Lead sponsor: HealthPartners InstituteUniversity, hospital or other
Collaborators: University of Minnesota, Minnesota Medical Foundation
Study start: Aug 2014
Primary completion: Jun 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 1 Oct 2014 (estimated)
Results: Posted 20 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Wedge Insert	Experimental	Other: Wedge InsertPatients will receive a wedge insert
Flat insert	Placebo comparator	Other: Flat InsertPatients will receive a flat insert

Who may qualify

Ages: 30 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Wedge Insert	Other	Wedge Insert
Flat Insert	Other	Flat insert

Primary outcome

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.
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.
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.
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.
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.
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.

2 secondary outcomes

Kellgren and Lawrence Classification of Osteoarthritis of Knee
Time frame: Baseline
Kellgren and Lawrence Classification of Osteoarthritis of Knee
Time frame: 6 months

Results and safety

Results posted to the registry on 20 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wedge Insert	9	7
Flat Insert	3	2

Primary outcome: Patient Reported Function and Pain

Time frame: Baseline. Mean (Full Range). Unit: score on a scale 0-10 (normal)

Measure	Wedge Insert n = 9	Flat Insert n = 3
Value	3.66 (1 to 6)	4.66 (4 to 5)

Primary outcome: Patient Reported Function and Pain

Time frame: 6 weeks. Mean (Full Range). Unit: score on a scale 0-10 (normal)

Measure	Wedge Insert n = 9	Flat Insert n = 3
Value	3.77 (1 to 6)	4 (2 to 5)

Primary outcome: Patient Reported Function and Pain

Time frame: 3 months. Mean (Full Range). Unit: score on a scale 0-10 (normal)

Measure	Wedge Insert n = 8	Flat Insert n = 3
Value	3.88 (1 to 7)	3.66 (2 to 5)

Primary outcome: Patient Reported Function and Pain

Time frame: 6 months. Mean (Full Range). Unit: score on a scale 0-10 (normal)

Measure	Wedge Insert n = 6	Flat Insert n = 2
Value	3.66 (1 to 6)	3.5 (2 to 5)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Wedge Insert	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9
Flat Insert	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wedge Insert and Flat Insert in people with Knee Osteoarthritis, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Reported Function and Pain (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02254473.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.