Clinical trial NCT04056845: Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients
Official title: Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2019-08-14
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective study
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Improvement in pain
timeFrame: At 16 weeks after the initiation of study
Secondary outcomes:
measure: Improvement in knee functioning
timeFrame: At 16 weeks after the initiation of the study
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hospital Authority
Study officials:
affiliation: Hospital Authority
name: Keith Hay-Man Wan, MBChB, FRCSEd(Orth)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Moyer 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.