Knee Osteoarthritis
Conditions
Keywords
Knee, Osteoarthritis
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.
Interventions
OTHERWedge Insert
OTHERFlat Insert
Sponsors
University of Minnesota
Minnesota Medical Foundation
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Function and Pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kellgren and Lawrence Classification of Osteoarthritis of Knee | Baseline | X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wedge Insert Patients will receive a wedge insert
Wedge Insert | 9 |
| Flat Insert Patients will receive a flat insert
Flat Insert | 3 |
| Total | 12 |
Baseline characteristics
| Characteristic | Flat Insert | Total | Wedge Insert |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 7 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 5 Participants | 5 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 3 participants | 12 participants | 9 participants |
| Sex: Female, Male Female | 1 Participants | 7 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 3 |
| other Total, other adverse events | 1 / 9 | 0 / 3 |
| serious Total, serious adverse events | 0 / 9 | 0 / 3 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wedge Insert | Patient Reported Function and Pain | 3.77 score on a scale 0-10 (normal) |
| Flat Insert | Patient Reported Function and Pain | 4 score on a scale 0-10 (normal) |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wedge Insert | Patient Reported Function and Pain | 3.88 score on a scale 0-10 (normal) |
| Flat Insert | Patient Reported Function and Pain | 3.66 score on a scale 0-10 (normal) |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wedge Insert | Patient Reported Function and Pain | 3.66 score on a scale 0-10 (normal) |
| Flat Insert | Patient Reported Function and Pain | 3.5 score on a scale 0-10 (normal) |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wedge Insert | Patient Reported Function and Pain | 3.66 score on a scale 0-10 (normal) |
| Flat Insert | Patient Reported Function and Pain | 4.66 score on a scale 0-10 (normal) |
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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wedge Insert | Patient Reported Function and Pain | 3.88 score on a scale 0-10 (normal) |
| Flat Insert | Patient Reported Function and Pain | 4 score on a scale 0-10 (normal) |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wedge Insert | Patient Reported Function and Pain | 3.17 score on a scale 0-10 (normal) |
| Flat Insert | Patient Reported Function and Pain | 4 score on a scale 0-10 (normal) |
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).
Time frame: Baseline
Population: Data was not gathered due to pre-mature termination of the study.
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).
Time frame: 6 months
Population: Data was not gathered due to pre-mature termination of the study.