Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?

NCT05693493 | Unknown DMC

• 1 other identifier: 2022.223-T
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee brace; Knee OA; Proprioceptive knee brace; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Changes of the time of 6-meter test

  The 6-meter test timed walking gait test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (\<7.5 seconds is normal).

  pre-op, 6-weeks, 6-months and 12-months post-op

• Changes of the time of Time up and go test (TUG)

  The Time up and go test (TUG) is to determine fall risk and measure the progress of balance, sit to stand and walking. Patients will be asked to stand up from a chair, walk as quickly as possible in their a safe and most comfortable gait until they pass to 3 meters (10 feet) end of marked course with both feet. Turn around and walk back to the chair, time will be counted to the moment until the back of patients touches the back of the chair.

  pre-op, 6-weeks, 6-months and 12-months post-op

• Change in the range of motion

  The active range of motion test predicts the mobility of the joint by measuring the amount of active knee extension and flexion. Knee extension: The patient is supine. The heel of the limb of interest is propped on a bolster, assuring the back of the knee and calf are not touching the support surface. The patient is asked to actively contract the quadriceps. The amount of knee extension is recorded with the goniometer. Knee flexion: The patient is prone. The patient flexes the knee as far as possible. The amount of knee flexion is recorded with the goniometer."

  pre-op, 6-weeks, 6-months and 12-months post-op

Secondary Outcomes (10)

• Knee extensor/flexor strength

  pre-op, 6-weeks, 6-months and 12-months post-op

• Short-form 12

  pre-op, 6-weeks, 6-months and 12-months post-op

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  pre-op, 6-weeks, 6-months and 12-months post-op

• The Forgotten Joint Score-12

  pre-op, 6-weeks, 6-months and 12-months post-op

• Knee stability test

  pre-op, 6-weeks, 6-months and 12-months post-op

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Device: Proprioceptive knee brace

Control group

NO INTERVENTION

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

Interventions

Proprioceptive knee brace DEVICE

For the intervention group that randomly consisted of 15 subjects will be using a design of knee brace (Reaction Web®; DonJoy, Vista, CA). The elastomeric web design helps to reduce pain by dispersing load across the knee. The web acts like a spring to absorb shock and shifts the peak loads away from the painful area of the knee. Elastomeric web acts to dynamically stabilise the patella on all sides, bringing the patella into proper tracking position to reduce pain for patients with general patellofemoral instabilities. Reaction Web® has dual-axis hinges that are flexible, creating synergy with the elastomeric web for optimal fit and support, and providing energy dispersion to the knee.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael Tim-Yun Ong

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Tim-Yun Ong

CONTACT

26364171; michael.ong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 23, 2023
• Study Start: September 26, 2022
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: Journal reviewers

Locations

HK (1)