Contact information
Type
Scientific
Primary contact
Mr Richard Jones
ORCID ID
Contact details
Room PO18
Brian Blatchford Building
University of Salford
Salford
M6 6PU
United Kingdom
+44 (0)161 295 2295
r.k.jones@salford.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Biomechanical assessment of medial compartment knee osteoarthritis before and after surgery
Acronym
Study hypothesis
1. There is no significant difference in the knee kinematics or kinetics in patients with medial compartment knee osteoarthritis when wearing the valgus knee brace or lateral wedged insole
2. There is no significant difference in the clinical outcome scores in patients with medial compartment knee osteoarthritis when wearing the valgus knee brace or lateral wedged insole
3. There is no significant difference in the knee kinematics or kinetics or clinical scores between the two treatments (valgus knee braces and lateral wedged insoles)
Ethics approval
1. Stockport Local Research Committee. Date of approval: 01/12/2003 (ref: 03/12/2363)
2. Salford and Trafford Local Research Ethics Committee (ref: 03/12/2363)
Study design
Randomised controlled crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Knee osteoarthritis
Intervention
Arm 1: A valgus knee brace which is classed as a direct orthotic
Arm 2: A lateral wedged insole which is classed as an indirect orthotic
Cross-over: Two week intervention period and a two-week wash-out period to account for carry-over effects from the first treatment.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Knee adduction moment
2. Knee kinematics and kinetics
These outcomes were assessed at the following timepoints:
T1: Baseline assessment and start of wear of intervention 1
T2. Two weeks following wear of intervention 1
T3. Two weeks after no treatment to deal with carry over effects, and start of intervention 2
T4. Two weeks following wear of intervention 2
Secondary outcome measures
1. Western Ontario and McMaster Osteoarthritis Index (WOMAC), Pain and Function Subscales
2. Knee Pain Visual Analogue Scale (VAS) (0 = no pain, 10 = extreme pain)
These outcomes were assessed at the following timepoints:
T1: Baseline assessment and start of wear of intervention 1
T2. Two weeks following wear of intervention 1
T3. Two weeks after no treatment to deal with carry over effects, and start of intervention 2
T4. Two weeks following wear of intervention 2
Overall trial start date
01/03/2003
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female between 45 and 75 years of age
2. Medial compartment knee osteoarthritis symptoms
3. Diagnosis confirmed on radiographs
4. Able to walk and stand on one leg for about three seconds
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
28
Participant exclusion criteria
1. Previous knee pain or any other musculo-skeletal conditions
2. Currently wears orthoses of any description prescribed by a podiatrist or orthotist
3. Tricompartmental knee osteoarthritis and/or clinical evidence of patellofemoral disease or knee pathology (other than medial compartment osteoarthritis) likely to be causing their knee pain
4. Unable to walk unsupported or stand on affected leg for 3 seconds
5. Severe coexisting medical morbidities
Recruitment start date
01/03/2003
Recruitment end date
01/10/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Room PO18
Salford
M6 6PU
United Kingdom
Sponsor information
Organisation
University of Salford (UK)
Sponsor details
Allerton Building
Frederick Road Campus
Salford
M6 6PU
United Kingdom
+44 (0)161 295 2295
r.k.jones@salford.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Salford (UK)
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22920242
Publication citations
-
Results
Jones RK, Nester CJ, Richards JD, Kim WY, Johnson DS, Jari S, Laxton P, Tyson SF, A comparison of the biomechanical effects of valgus knee braces and lateral wedged insoles in patients with knee osteoarthritis., Gait Posture, 2013, 37, 3, 368-372, doi: 10.1016/j.gaitpost.2012.08.002.