N/A
N=38
Using Pressure Detecting Insoles to Reduce Knee Loading
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02955225 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Change in Knee Adduction Moment Relative to Baseline — -0.21; -0.09; -0.21; -0.24 percentage of bodyweight x height
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Moticon OpenGO insole (Device); Passive shoe insole (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Knee Adduction Moment Relative to Baseline |
-0.21; -0.09; -0.21; -0.24; -0.12; -0.12 | — |
| SECONDARY Change in Moment Lever-arm for KAM |
-6; 1; -5; 3; -2; 3 | — |
| SECONDARY Change in SPEED |
-.09; .05; -.04; .08; -.01; .06 | — |
| SECONDARY Change in Knee Pain |
4.3; 10.0; 7.0; 12.3 | — |
| SECONDARY Change in Self-reported Functional Status Between Baseline, After 3 Weeks of Training, and After 6 Weeks of Training |
8.5; 8.5; 15.6; 6.7 | — |
Summary
The purpose of this study is to determine whether use of a pressure-detecting shoe improve can enhance favorable loading conditions at the knee.
Eligibility Criteria
Inclusion Criteria
- Able and willing to give informed consent and comply with the study protocol.
- Symptomatic OA of the knee greater than 3 months, as defined by the American College of Rheumatology's Clinical Criteria for Classification and Reporting of OA of the Knee. If symptoms are bilateral, then the knee identified as more symptomatic will serve as the index knee.
- Ambulatory knee pain, defined as the presence of greater than 30 mm of pain while walking on a flat surface (corresponding to question 1 of the visual analog format of the WOMAC).
- Radiographic OA of the study knee of grade 2 or 3, as defined by the modified Kellgren and Lawrence (K-L) grading scale.
- Medial compartment OA, defined as either qualitative joint space narrowing of ≥ 1or the presence of medial bone cyst, sclerosis, or osteophyte.
- Able to walk at least 10 minutes without a break.
- Age of 40 years or older
Exclusion Criteria
- Unwillingness to wear study shoes for at least 6 hours/day for 6 days of the week
- Knee flexion contracture of > 15 degrees or inability to ambulate without assistance.
- Presence of clinical OA of the ankle or hip or ankle/hip pain>10 mm (WOMAC).
- Predominant lateral compartment OA, defined as narrowing of the lateral joint space in excess of the narrowing of the medial joint space in either knee.
- Concurrent systemic inflammatory arthropathy
- Prior knee or hip arthroplasty, or surgical arthroscopy within the previous 3 months.
- Intrinsic foot disease: hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated particular footwear.
- Intra-articular knee injection: steroids within 6 wks, hyaluronan derivatives within 4 mos.
- Body mass index greater than 38.
Data sourced from ClinicalTrials.gov (NCT02955225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.