Inlay versus brace treatment for medial knee osteoarthritis: a randomised trial

ISRCTN	ISRCTN92527149
DOI	https://doi.org/10.1186/ISRCTN92527149
Protocol serial number	NTR484; 3
Sponsor	Erasmus Medical Centre (Netherlands)
Funders	Erasmus Medisch Centrum, Algesiology Foundation (Stichting Algesiologie) (Netherlands), The Anna Fonds Foundations (Stichting Anna Fonds) (Netherlands)

Submission date: 27/01/2006
Registration date: 27/01/2006
Last edited: 12/03/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr T.M. Raaij, van
Scientific

Erasmus University Medical Centre
Department of Orthopaedic Surgery
P.O. Box 2040
Rotterdam
3000 CB
Netherlands

Email	t.vanraaij@chello.nl

Study information

Primary study design	Interventional
Study design	Randomised open-label active-controlled parallel-group trial
Secondary study design	Randomised controlled trial
Scientific title	Inlay versus brace treatment for medial knee osteoarthritis: a randomised trial
Study acronym	SOLE
Study objectives	An inlay for the treatment of medial knee osteoarthritis will result in pain reduction, function improvement and better compliance then brace treatment.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Arthritis, Osteoarthritis
Intervention	Group 1: lateral wedge sole (inlay) Group 2: valgisation knee brace (brace)
Intervention type	Other
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key 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.
Key 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.
Date of first enrolment	01/10/2005
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus University Medical Centre

Rotterdam
3000 CB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2010		Yes	No