Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Device: Proprioceptive knee brace

Study type: Interventional

Funder types: Other

Identifiers

NCT05693493

2022.223-T

Details and patient eligibility

About

Osteoarthritis is among the most prevalent form of degenerative joint disease in arthritis. The World Health Organisation identified osteoarthritis as one of the top ten most disabling cause of disease in developed countries, and the single most common cause of disability for elderly persons. In fact, worldwide statistics for men and women over 60 years of age with signs of symptomatic osteoarthritis are estimated to be at 9.6% and 18.0% respectively. In Hong Kong, the latest census revealed that 514,000 people suffer from degenerative arthritis, representing 0.7% of the population. Although these values are much lower than the international figures reported by the WHO, it is inevitable that the prevalence of osteoarthritis will continue to rise with an increasing trend of obesity and an aging population in Hong Kong. Similar to any other chronic disease with wide prevalence, the impact of osteoarthritis translates to a substantial socioeconomic burden on a societal level.

Total knee arthroplasty has become the gold standard to manage the pain and disability associated with end-stage arthritis who have exhausted all conservative measures. Although contemporary advances in prosthesis design, surgical techniques, postoperative rehabilitation regimes have hasten patient's recovery, the restoration of proprioception and neuromuscular control is often prolonged despite solid rehabilitation regimes.

Knee bracing is one of the non-pharmacological modalities designed to evenly distribute load and provide proprioceptive feedbacks for those with knee injuries or knee pain. There are four categories of knee braces for the purpose of prophylactic, functional, rehabilitative and unloader/off-load. This study will mainly be focusing on the effects of the unloader/off-loader brace. Previous studies have demonstrated the effects on alteration of kinematic variables, including range of movement (p=0.002), speed of walking (p<0.001) and knee adduction moment (p=0.001) for knee injuries and osteoarthritis as a part of the conservative management protocol. However, there have few studies that investigated whether proprioceptive knee bracing has any role in functional recovery post total knee arthroplasty.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult (age over 18 years old) underwent Total Knee Arthroplasty within 2 to 4 weeks;
2. Adult who is able to provide written consent and compliance with treatment and assessment regime

Exclusion criteria

1. Patients with disabilities, wheelchair dependence for mobility;
2. Underwent revision Total Knee Arthroplasty;
3. Found with complication wounds following surgery;
4. Diagnosed with comorbidities e.g. inflammatory arthritis, obesity, dermatological disorders that might affect their compliance to treatment;
5. Do not fit to the sizes of knee braces;
6. Not to given written consent and be non-compliance with the treatment and assessment regime

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Intervention group

Experimental group

Description:

Device: Proprioceptive knee brace Subjects will use proprioceptive knee brace for 6 weeks post-op, in addition to basic management such as physiotherapy.

Treatment:

Device: Proprioceptive knee brace

Control group

No Intervention group

Description:

No device. Subjects will receive basic management such as physiotherapy.