Contact information
Type
Scientific
Primary contact
Dr T.M. Raaij, van
ORCID ID
Contact details
Erasmus University Medical Centre
Department of Orthopaedic Surgery
P.O. Box 2040
Rotterdam
3000 CB
Netherlands
-
t.vanraaij@chello.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR484; 3
Study information
Scientific title
Inlay versus brace treatment for medial knee osteoarthritis: a randomised trial
Acronym
SOLE
Study hypothesis
An inlay for the treatment of medial knee osteoarthritis will result in pain reduction, function improvement and better compliance then brace treatment.
Ethics approval
Received from local medical ethics committee
Study design
Randomised open-label active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Arthritis, Osteoarthritis
Intervention
Group 1: lateral wedge sole (inlay)
Group 2: valgisation knee brace (brace)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Will inlay treatment for patients with symptomatic medial knee osteoarthritis yield better results then brace treatment?
Measurements:
1. Painscore (VAS)
2. Hospital for Special Surgery (HHS) Knee Service Rating System
3. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Secondary outcome measures
1. Will there be a functional difference between both groups?
Measurements:
1.1. Gait analysis (knee adduction moment, toeing-out, knee extension moment)
1.2. Knee range of motion
1.3. Patient satisfaction
1.4. Maximum walking distance
2. Will conservative treatment (inlay or brace) give a favourable outcome for medial knee osteoarthritis?
Measurements:
2.1. Dual energy x-ray absorptiometry (DEXA-scan)
2.2. Osteoarthritis markers (serum and urine)
2.3. Hip-knee-ankle (HKA) angle
Overall trial start date
01/10/2005
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients (male and female) with symptomatic medial osteoarthritis of the knee. Patients will be included after informed consent given and baseline measurements made.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Below 35 or above 60 years of age
2. Symptoms not related to medial osteoarthritis of the knee
3. Not able to speak or understand Dutch.
Recruitment start date
01/10/2005
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus University Medical Centre
Rotterdam
3000 CB
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medisch Centrum
Alternative name(s)
Erasmus Medical Center, Erasmus MC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Funder name
Algesiology Foundation (Stichting Algesiologie) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Anna Fonds Foundations (Stichting Anna Fonds) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20177839