Anterior Heel Wedge to Treat Flexion Contracture After Total Knee Arthroplasty

University of North Carolina, Charlotte

Status and phase: Completed; Early Phase 1

Conditions: Knee Flexion Contracture; Total Knee Arthroplasty (TKA)

Treatments: Device: Anterior heel wedge

Study type: Interventional

Funder types: Other

Identifiers

NCT07620145

22-1206

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Orthotic

Experimental group

Description:

Participants enrolled in this arm wear an anterior heel wedge, in the form of a shoe orthotic, to improve walking and reduce knee flexion contracture. The wedge is worn continuously on the shoe for 1 month.

Treatment:

Device: Anterior heel wedge