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

ISRCTN ISRCTN92527149
DOI https://doi.org/10.1186/ISRCTN92527149
Secondary identifying numbers NTR484; 3
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

Study designRandomised open-label active-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleInlay versus brace treatment for medial knee osteoarthritis: a randomised trial
Study acronymSOLE
Study objectivesAn 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) studiedArthritis, Osteoarthritis
InterventionGroup 1: lateral wedge sole (inlay)
Group 2: valgisation knee brace (brace)
Intervention typeOther
Primary outcome measureWill 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 measures1. 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 study start date01/10/2005
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteriaPatients (male and female) with symptomatic medial osteoarthritis of the knee. Patients will be included after informed consent given and baseline measurements made.
Key exclusion criteria1. 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 enrolment01/10/2005
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus University Medical Centre
Rotterdam
3000 CB
Netherlands

Sponsor information

Erasmus Medical Centre (Netherlands)
Hospital/treatment centre

Dr. Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Hospital/treatment centre

Erasmus Medisch Centrum
Government organisation / Universities (academic only)
Alternative name(s)
Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
Location
Netherlands
Algesiology Foundation (Stichting Algesiologie) (Netherlands)

No information available

The Anna Fonds Foundations (Stichting Anna Fonds) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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