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

To investigate whether the use of valgus knee brace is useful for patients with medial knee osteoarthritis.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Valgus knee brace (Medex K39-OA Corrector); Other: Physiotherapy and oral analgesic (diclofenac and panadol)

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keith Hay-Man Wan, MBChB, FRCSEd(Orth); Phone Number: +852 90384422; Email: keithayman@hotmail.com
• Study Contact Backup: Name: Siu Tong Choi, MBBS, FHKCOS

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Hospital Authority
    • Contact: Keith Wan, MB ChB, FRCSEd (Orth); Phone Number: 90384422; Email: keithayman@hotmail.com
    • Contact: Siu Tong Choi, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Knee brace group; 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).	Device: Valgus knee brace (Medex K39-OA Corrector); Valgus knee brace given to patients as part of the conservative management for knee osteoarthritis.; Other: Physiotherapy and oral analgesic (diclofenac and panadol); Physiotherapy and oral analgesic (diclofenac and panadol)
Active Comparator: Control Group; Patients in this group will receive physiotherapy and oral analgesic (diclofenac and panadol).	Other: Physiotherapy and oral analgesic (diclofenac and panadol); Physiotherapy and oral analgesic (diclofenac and panadol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in pain	Visual Analog Scale (VAS) for pain from 0 to 10, with higher value signifying worse pain control	At 16 weeks after the initiation of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in knee functioning	The Western Ontario and McMaster Universities Osteoarthritis Index	At 16 weeks after the initiation of the study

Collaborators and Investigators

• Sponsor: Hospital Authority, Hong Kong
• Investigators: Principal Investigator: Keith Hay-Man Wan, MBChB, FRCSEd(Orth), Hospital Authority

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 18, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Diclofenac; Analgesics
• Other Study ID Numbers: HAREC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No