Condition category
Musculoskeletal Diseases
Date applied
22/02/2008
Date assigned
03/03/2008
Last edited
04/01/2013
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

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

http://www.salford.ac.uk

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

  1. 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.

Additional files

Editorial Notes