Condition category
Musculoskeletal Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
12/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Dr. Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20177839

Publication citations

Additional files

Editorial Notes