NCT04056845

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

May 29, 2019

Last Update Submit

August 18, 2019

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Improvement in knee functioning

    At 16 weeks after the initiation of the study

Study Arms (2)

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).

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).

Other: Physiotherapy and oral analgesic (diclofenac and panadol)

Interventions

Valgus knee brace (Medex K39-OA Corrector)DEVICE

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

Knee brace group
Physiotherapy and oral analgesic (diclofenac and panadol)OTHER

Physiotherapy and oral analgesic (diclofenac and panadol)

Control GroupKnee brace group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Authority

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

  • 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.

    PMID: 25756275BACKGROUND

  • 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.

    PMID: 25201520BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy ModalitiesAnalgesicsDiclofenacAcetaminophen

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Keith Hay-Man Wan, MBChB, FRCSEd(Orth)

    Hospital Authority

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith Hay-Man Wan, MBChB, FRCSEd(Orth)

CONTACT

+852 90384422keithayman@hotmail.com

Siu Tong Choi, MBBS, FHKCOS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Outcome assessors are blinded from the treatment received
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized prospective study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Specialist

Study Record Dates

First Submitted

May 29, 2019

First Posted

August 14, 2019

Study Start

September 1, 2019

Primary Completion

December 31, 2020

Study Completion

June 30, 2021

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)