Clinical trial NCT05693493: Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?
Official title: Can Proprioceptive Knee Brace Improve Functional Outcome Following Total Knee Arthroplasty?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee brace
Knee OA
Proprioceptive knee brace
Knee Osteoarthritis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of the time of 6-meter test
timeFrame: pre-op, 6-weeks, 6-months and 12-months post-op
measure: Changes of the time of Time up and go test (TUG)
timeFrame: pre-op, 6-weeks, 6-months and 12-months post-op
measure: Change in the range of motion
timeFrame: pre-op, 6-weeks, 6-months and 12-months post-op
Secondary outcomes:
measure: Knee extensor/flexor strength
timeFrame: pre-op, 6-weeks, 6-months and 12-months post-op
measure: Short-form 12
timeFrame: pre-op, 6-weeks, 6-months and 12-months post-op
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: pre-op, 6-weeks, 6-months and 12-months post-op
measure: The Forgotten Joint Score-12
timeFrame: pre-op, 6-weeks, 6-months and 12-months post-op
measure: Knee stability test
timeFrame: pre-op, 6-weeks, 6-months and 12-months post-op
measure: Knee Society Score (KSS)
timeFrame: pre-op, 6-weeks, 6-months and 12-months post-op
measure: Knee Society Function Score (KFS)
timeFrame: pre-op, 6-weeks, 6-months and 12-months post-op
measure: Clinical Research Compliance assessment: compliance to intervention
timeFrame: 6-weeks, 6-months and 12-months post-op
measure: Clinical Research Compliance assessment: compliance to routine physiotherapy
timeFrame: 6-weeks, 6-months and 12-months post-op
measure: Patients satisfaction Survey
timeFrame: pre-op, 6-weeks, 6-months and 12-months post-op
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Michael Tim-Yun Ong
role: PRINCIPAL_INVESTIGATOR
References: