Knee Flexion Contracture, Total Knee Arthroplasty (TKA)
Conditions
Keywords
walking, knee, range of motion
Brief summary
Total knee arthroplasty (TKA) remains the only treatment for end-stage knee osteoarthritis, whereby the diseased ends of the bones comprising the knee joint are removed and replaced with prosthetic joint components. Approximately 500,000 of these procedures are performed annually in the United States. Despite an otherwise successful procedure and post-operative rehabilitation process, about 5% of all individuals will develop a flexion contracture after TKA. Flexion contracture limits the knee joint range of motion, which has negative impacts on activities of daily living and health-related quality of life. Standard of care treatment for resolving flexion contracture requires more surgery or, at minimum, more exposure to anesthesia to manipulate the joint and improve range of motion. The investigators have developed a non-invasive means for resolving flexion contracture, The investigators propose fixing a wedge to the sole of the patient's shoe such that the taller end of the wedge is located near the toes and the shorter end is closer to the heel. Biomechanically, this forces the individual to make ground contact during walking closer to the heel rather than the toes (which is typically observed in patients with flexion contracture). By forcing ground contact closer to the heel, patients gradually force their knee to extend (straighten) over time and resolve the flexion contracture. The aim of this pilot investigation is to test the hypothesis that the anterior wedge worn on the shoe during all walking activities for 4 weeks will reduce the severity of the flexion contracture in patients after TKA.
Interventions
DEVICEAnterior heel wedge
A continuously-worn shoe anterior heel wedge that fits on the under surface of the shoe just under the toe box. When worn during walking, the anterior heel wedge may help to increase knee joint range of motion and reduce knee flexion contracture in patients after total knee arthroplasty.
Sponsors
University of North Carolina, Charlotte
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* over the age of 18 years * underwent primary, unilateral TKA and approved for participation by surgeon * present with flexion contracture in the operative limb (5 degrees or greater at least 3 months after surgery) * body mass index \<40kg/m\^2
Exclusion criteria
* underwent revision TKA * underwent bilateral TKA * require use of assistive device to walk * inability to consistently comprehend and repeat back directions, including for reasons of not understanding/speaking English * current smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait biomechanics | From enrollment to the end of treatment at 4 weeks | Participants will walk over level ground at a self-selected pace and one equivalent to average older adult walking speed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcomes | From baseline to the end of the intervention at 4 weeks | Participants will complete the Knee Osteoarthritis Outcomes Survey (0-100, higher scores are better). |
Countries
United States
Outcome results
None listed