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Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Proprioceptive knee brace
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Knee brace, Knee OA, Proprioceptive knee brace, Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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.
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."

Secondary Outcome Measures

Knee extensor/flexor strength
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee extension/flexion movement is measured by the dynamometer attached at the malleoli level with a strap. The measurements will be taken at maximum force for three times.
Short-form 12
The SF-12 health survey uses 12 questions to measure patient's functional health and well-being from a patient's point of view. It is reliable and validated measure that summaries the patients' physical and mental health. The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations).
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC questionnaire is a questionnaire that measures patient's pain, stiffness and physical function and can be summed up into a score out of 96. A high score indicates a more disabled participant.
The Forgotten Joint Score-12
The FJS-12 comprise measures for the assessment of joint-specific patient-reported outcome in their ability to forget about a joint as a result of successful treatment. Join awareness can be simply defined as any unintended perception of a joint. It is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities
Knee stability test
KT-1000 will be used at the assessing of knee laxity as it provides an objective evaluation of knee stability resulting from the automated anterior drawer test it performs.
Knee Society Score (KSS)
The KSS is an instrument assessing patient's pain and functionality based on a series of questions interviewed by a clinician. The validated questionnaire combines the objective physician derived component with a subjective patient derived component which evaluates pain, functionality, satisfaction and fulfillment of expectations. The results will be calculating the total score with 100 being the highest and 0 the lowest.
Knee Society Function Score (KFS)
The validated questionnaire combines the objective physician derived component with a subjective patient derived component which evaluates pain, functionality, satisfaction and fulfillment of expectations. The results will be calculating the total score with 100 being the highest and 0 the lowest.
Clinical Research Compliance assessment: compliance to intervention
Clinical Research Compliance assessment will be conducted to measures the period and amount of time designated knee brace has been put on as interventional means.
Clinical Research Compliance assessment: compliance to routine physiotherapy
It recorded the attendance of routine post-operative procedures of physiotherapy training one might receive.
Patients satisfaction Survey
Patients satisfaction Survey is to be recorded in terms not only how well to the quality of care patient was being treated, but to also the content a patient is with the care they received.

Full Information

First Posted
December 14, 2022
Last Updated
January 11, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05693493
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee brace, Knee OA, Proprioceptive knee brace, Knee Osteoarthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Device: Proprioceptive knee brace Subjects will use proprioceptive knee brace for 6 weeks post-op, in addition to basic management such as physiotherapy.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No device. Subjects will receive basic management such as physiotherapy.
Intervention Type
Device
Intervention Name(s)
Proprioceptive knee brace
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of the time of 6-meter test
Description
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).
Time Frame
pre-op, 6-weeks, 6-months and 12-months post-op
Title
Changes of the time of Time up and go test (TUG)
Description
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.
Time Frame
pre-op, 6-weeks, 6-months and 12-months post-op
Title
Change in the range of motion
Description
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."
Time Frame
pre-op, 6-weeks, 6-months and 12-months post-op
Secondary Outcome Measure Information:
Title
Knee extensor/flexor strength
Description
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee extension/flexion movement is measured by the dynamometer attached at the malleoli level with a strap. The measurements will be taken at maximum force for three times.
Time Frame
pre-op, 6-weeks, 6-months and 12-months post-op
Title
Short-form 12
Description
The SF-12 health survey uses 12 questions to measure patient's functional health and well-being from a patient's point of view. It is reliable and validated measure that summaries the patients' physical and mental health. The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations).
Time Frame
pre-op, 6-weeks, 6-months and 12-months post-op
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
The WOMAC questionnaire is a questionnaire that measures patient's pain, stiffness and physical function and can be summed up into a score out of 96. A high score indicates a more disabled participant.
Time Frame
pre-op, 6-weeks, 6-months and 12-months post-op
Title
The Forgotten Joint Score-12
Description
The FJS-12 comprise measures for the assessment of joint-specific patient-reported outcome in their ability to forget about a joint as a result of successful treatment. Join awareness can be simply defined as any unintended perception of a joint. It is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities
Time Frame
pre-op, 6-weeks, 6-months and 12-months post-op
Title
Knee stability test
Description
KT-1000 will be used at the assessing of knee laxity as it provides an objective evaluation of knee stability resulting from the automated anterior drawer test it performs.
Time Frame
pre-op, 6-weeks, 6-months and 12-months post-op
Title
Knee Society Score (KSS)
Description
The KSS is an instrument assessing patient's pain and functionality based on a series of questions interviewed by a clinician. The validated questionnaire combines the objective physician derived component with a subjective patient derived component which evaluates pain, functionality, satisfaction and fulfillment of expectations. The results will be calculating the total score with 100 being the highest and 0 the lowest.
Time Frame
pre-op, 6-weeks, 6-months and 12-months post-op
Title
Knee Society Function Score (KFS)
Description
The validated questionnaire combines the objective physician derived component with a subjective patient derived component which evaluates pain, functionality, satisfaction and fulfillment of expectations. The results will be calculating the total score with 100 being the highest and 0 the lowest.
Time Frame
pre-op, 6-weeks, 6-months and 12-months post-op
Title
Clinical Research Compliance assessment: compliance to intervention
Description
Clinical Research Compliance assessment will be conducted to measures the period and amount of time designated knee brace has been put on as interventional means.
Time Frame
6-weeks, 6-months and 12-months post-op
Title
Clinical Research Compliance assessment: compliance to routine physiotherapy
Description
It recorded the attendance of routine post-operative procedures of physiotherapy training one might receive.
Time Frame
6-weeks, 6-months and 12-months post-op
Title
Patients satisfaction Survey
Description
Patients satisfaction Survey is to be recorded in terms not only how well to the quality of care patient was being treated, but to also the content a patient is with the care they received.
Time Frame
pre-op, 6-weeks, 6-months and 12-months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Tim-Yun Ong
Phone
26364171
Email
michael.ong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Tim-Yun Ong
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Tim-Yun Ong
Phone
26364171
Email
michael.ong@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
Journal reviewers

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Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?

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