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Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients

Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04056845
Enrollment
80
Registered
2019-08-14
Start date
2019-09-01
Completion date
2021-06-30
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

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.

Interventions

DEVICEValgus knee brace (Medex K39-OA Corrector)

Valgus knee brace given to patients as part of the conservative management for knee osteoarthritis.

OTHERPhysiotherapy and oral analgesic (diclofenac and panadol)

Physiotherapy and oral analgesic (diclofenac and panadol)

Sponsors

Hospital Authority, Hong Kong
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Outcome assessors are blinded from the treatment received

Intervention model description

Randomized prospective study

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in painAt 16 weeks after the initiation of studyVisual Analog Scale (VAS) for pain from 0 to 10, with higher value signifying worse pain control

Secondary

MeasureTime frameDescription
Improvement in knee functioningAt 16 weeks after the initiation of the studyThe Western Ontario and McMaster Universities Osteoarthritis Index

Countries

Hong Kong

Contacts

Primary ContactKeith Hay-Man Wan, MBChB, FRCSEd(Orth)
keithayman@hotmail.com+852 90384422
Backup ContactSiu Tong Choi, MBBS, FHKCOS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026