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

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Valgus knee brace (Medex K39-OA Corrector)
Physiotherapy and oral analgesic (diclofenac and panadol)
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital AuthorityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Knee brace group

Control Group

Arm Description

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).

Patients in this group will receive physiotherapy and oral analgesic (diclofenac and panadol).

Outcomes

Primary Outcome Measures

Improvement in pain
Visual Analog Scale (VAS) for pain from 0 to 10, with higher value signifying worse pain control

Secondary Outcome Measures

Improvement in knee functioning
The Western Ontario and McMaster Universities Osteoarthritis Index

Full Information

First Posted
May 29, 2019
Last Updated
August 18, 2019
Sponsor
Hospital Authority, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04056845
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Authority, 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective study
Masking
InvestigatorOutcomes Assessor
Masking Description
Outcome assessors are blinded from the treatment received
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Knee brace group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive physiotherapy and oral analgesic (diclofenac and panadol).
Intervention Type
Device
Intervention Name(s)
Valgus knee brace (Medex K39-OA Corrector)
Intervention Description
Valgus knee brace given to patients as part of the conservative management for knee osteoarthritis.
Intervention Type
Other
Intervention Name(s)
Physiotherapy and oral analgesic (diclofenac and panadol)
Intervention Description
Physiotherapy and oral analgesic (diclofenac and panadol)
Primary Outcome Measure Information:
Title
Improvement in pain
Description
Visual Analog Scale (VAS) for pain from 0 to 10, with higher value signifying worse pain control
Time Frame
At 16 weeks after the initiation of study
Secondary Outcome Measure Information:
Title
Improvement in knee functioning
Description
The Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame
At 16 weeks after the initiation of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keith Hay-Man Wan, MBChB, FRCSEd(Orth)
Phone
+852 90384422
Email
keithayman@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Siu Tong Choi, MBBS, FHKCOS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Hay-Man Wan, MBChB, FRCSEd(Orth)
Organizational Affiliation
Hospital Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Authority
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Wan, MB ChB, FRCSEd (Orth)
Phone
90384422
Email
keithayman@hotmail.com
First Name & Middle Initial & Last Name & Degree
Siu Tong Choi, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25756275
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.
Results Reference
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PubMed Identifier
25201520
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.
Results Reference
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Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients

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