Osteoarthritis, KneeNCT04056845
Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients
A study testing Valgus knee brace (Medex K39-OA Corrector) and Physiotherapy and oral analgesic (diclofenac and panadol) in people with Osteoarthritis, Knee, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
Trial summary
To investigate whether the use of valgus knee brace is useful for patients with medial knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Valgus knee brace (Medex K39-OA Corrector) and Physiotherapy and oral analgesic (diclofenac and panadol)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40-80
- History of symptomatic medial unicompartmental knee osteoarthritis > 6 months
- Willingness to wear the knee brace for a minimum of 4 hours per day during daily activities
- Understanding of the Chinese language
- Ethnic Chinese patients
Who cannot join
- Symptomatic knee osteoarthritis affecting more than one compartment
- Clinical and radiological signs of osteoarthritis over the lateral compartment or patello-femoral joint
- Significant knee effusion or soft tissue compromise preventing long-term knee brace use
- Obesity (BMI>30)
- Previous surgery on the affected knee other than diagnostic arthroscopy with debridement, soft tissue reconstruction, menisectomy
- Peripheral vascular disease of the lower limb
Trial locations and contacts
1 site in 1 country.
Siu Tong Choi, MBBS, FHKCOS contact
Hong Kong1 site, 1 recruiting
- Recruiting
Hospital Authority
Hong Kong
Keith Wan, MB ChB, FRCSEd (Orth), 90384422, keithayman@hotmail.com
Siu Tong Choi, MBBS
About this study
To investigate whether the use of valgus knee brace is useful for patients with medial knee osteoarthritis.
Read the detailed description
Osteoarthritis of the knee is the commonest type of arthritis affecting both the middle age and geriatric population, which poses a huge burden to our in-patient and out-patient orthopaedic services. Conservative treatment like physiotherapy and analgesic provide temporary symptomatic relief. Surgical treatment like high tibial osteotomy and knee arthroplasty are not without major potential surgical risks and implant-related complications.
Orthotic treatment can theoretically alter the loading to the knee joint and help to reduce the symptoms and disease progression. Small scale biomechanical studies have demonstrated such effects with the use of valgus knee brace (2-4). Though prospective clinical outcome studies on Chinese patients in our locality are lacking.
Valgus knee brace is a non-pharmaceutical, non-invasive option for knee pain. Using a three-point leverage the unloader brace is to shift the stress away from the arthritic area to the normal portion of the knee, maintains good alignment and stability and thus provides significant pain relief during daily activities. It has been commonly used as a first line management option in other countries.
Our aim is to perform a prospective randomized study to look at the difference in outcome measures in osteoarthritic patients with the use of valgus knee brace, on top of the usual regime of conservative treatment.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Valgus knee brace (Medex K39-OA Corrector), Physiotherapy and oral analgesic (diclofenac and panadol)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valgus knee brace (Medex K39-OA Corrector)Device
Valgus knee brace given to patients as part of the conservative management for knee osteoarthritis.
Physiotherapy and oral analgesic (diclofenac and panadol)Other
Physiotherapy and oral analgesic (diclofenac and panadol)
| Study group | Role | What they receive |
|---|---|---|
| Knee brace group | Experimental | Patients in this group will receive a valgus knee brace (Medex K39-OA Corrector), to be worn for at least four hours a day, during the study period, on top of the presrciption of physiotherapy and oral analgesic (diclofenac and panadol). Receives: Device: Valgus knee brace (Medex K39-OA Corrector); Other: Physiotherapy and oral analgesic (diclofenac and panadol) |
| Control Group | Active comparator | Patients in this group will receive physiotherapy and oral analgesic (diclofenac and panadol). Receives: Other: Physiotherapy and oral analgesic (diclofenac and panadol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pain
Visual Analog Scale (VAS) for pain from 0 to 10, with higher value signifying worse pain control
Measured: At 16 weeks after the initiation of study
Secondary outcomes (1)
Improvement in knee functioning
The Western Ontario and McMaster Universities Osteoarthritis Index
Measured: At 16 weeks after the initiation of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Keith Hay-Man Wan, Hospital Authority, Hong Kong
- Investigators
- Keith Hay-Man Wan, MBChB, FRCSEd(Orth), Principal investigator, Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056845
- Sponsor's protocol ID
- HAREC
- Status last verified
- Aug 2019
- First submitted
- 29 May 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu HC, Lie CW, Ng TP, Chen KW, Tse CY, Wong WH. Prospective study on the effects of orthotic treatment for medial knee osteoarthritis in Chinese patients: clinical outcome and gait analysis. Hong Kong Med J. 2015 Apr;21(2):98-106. doi: 10.12809/hkmj144311. Epub 2015 Mar 10.
PubMed 25756275Moyer RF, Birmingham TB, Bryant DM, Giffin JR, Marriott KA, Leitch KM. Valgus bracing for knee osteoarthritis: a meta-analysis of randomized trials. Arthritis Care Res (Hoboken). 2015 Apr;67(4):493-501. doi: 10.1002/acr.22472.
PubMed 25201520
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients
- ClinicalTrials.gov ID
- NCT04056845
- Acronym / sponsor ID
- HAREC
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether the use of valgus knee brace is useful for patients with medial knee osteoarthritis.
Detailed description
Osteoarthritis of the knee is the commonest type of arthritis affecting both the middle age and geriatric population, which poses a huge burden to our in-patient and out-patient orthopaedic services. Conservative treatment like physiotherapy and analgesic provide temporary symptomatic relief. Surgical treatment like high tibial osteotomy and knee arthroplasty are not without major potential surgical risks and implant-related complications.
Orthotic treatment can theoretically alter the loading to the knee joint and help to reduce the symptoms and disease progression. Small scale biomechanical studies have demonstrated such effects with the use of valgus knee brace (2-4). Though prospective clinical outcome studies on Chinese patients in our locality are lacking.
Valgus knee brace is a non-pharmaceutical, non-invasive option for knee pain. Using a three-point leverage the unloader brace is to shift the stress away from the arthritic area to the normal portion of the knee, maintains good alignment and stability and thus provides significant pain relief during daily activities. It has been commonly used as a first line management option in other countries.
Our aim is to perform a prospective randomized study to look at the difference in outcome measures in osteoarthritic patients with the use of valgus knee brace, on top of the usual regime of conservative treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized prospective study
| Arm | Type | Receives |
|---|---|---|
| Knee brace group | Experimental | Device: Valgus knee brace (Medex K39-OA Corrector), Other: Physiotherapy and oral analgesic (diclofenac and panadol)Patients in this group will receive a valgus knee brace (Medex K39-OA Corrector), to be worn for at least four hours a day, during the study period, on top of the presrciption of physiotherapy and oral analgesic (diclofenac and panadol). |
| Control Group | Active comparator | Other: Physiotherapy and oral analgesic (diclofenac and panadol)Patients in this group will receive physiotherapy and oral analgesic (diclofenac and panadol). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 40-80
- History of symptomatic medial unicompartmental knee osteoarthritis > 6 months
- Willingness to wear the knee brace for a minimum of 4 hours per day during daily activities
- Understanding of the Chinese language
- Ethnic Chinese patients
Key exclusion criteria (6 listed)
- Symptomatic knee osteoarthritis affecting more than one compartment
- Clinical and radiological signs of osteoarthritis over the lateral compartment or patello-femoral joint
- Significant knee effusion or soft tissue compromise preventing long-term knee brace use
- Obesity (BMI>30)
- Previous surgery on the affected knee other than diagnostic arthroscopy with debridement, soft tissue reconstruction, menisectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valgus knee brace (Medex K39-OA Corrector)Valgus knee brace given to patients as part of the conservative management for knee osteoarthritis. | Device | Knee brace group |
| Physiotherapy and oral analgesic (diclofenac and panadol)Physiotherapy and oral analgesic (diclofenac and panadol) | Other | Control Group, Knee brace group |
Primary outcome
Improvement in pain
Time frame: At 16 weeks after the initiation of study
Visual Analog Scale (VAS) for pain from 0 to 10, with higher value signifying worse pain control
1 secondary outcome
Improvement in knee functioning
Time frame: At 16 weeks after the initiation of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Background: PubMed 25756275Fu HC, Lie CW, Ng TP, Chen KW, Tse CY, Wong WH. Prospective study on the effects of orthotic treatment for medial knee osteoarthritis in Chinese patients: clinical outcome and gait analysis. Hong Kong Med J. 2015 Apr;21(2):98-106. doi: 10.12809/hkmj144311. Epub 2015 Mar 10.
- Background: PubMed 25201520Moyer RF, Birmingham TB, Bryant DM, Giffin JR, Marriott KA, Leitch KM. Valgus bracing for knee osteoarthritis: a meta-analysis of randomized trials. Arthritis Care Res (Hoboken). 2015 Apr;67(4):493-501. doi: 10.1002/acr.22472.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siu Tong Choi, MBBS, FHKCOS contact
Keith Hay-Man Wan, MBChB, FRCSEd(Orth) principal investigator
Hospital Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valgus knee brace (Medex K39-OA Corrector) and Physiotherapy and oral analgesic (diclofenac and panadol) in people with Osteoarthritis, Knee, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith Hay-Man Wan, MBChB, FRCSEd(Orth) (+852 90384422, keithayman@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in pain (time frame: At 16 weeks after the initiation of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04056845, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.