Plain English Summary
Background and study aims
Malformation of the grove within which the knee cap articulates is known as trochlea dysplasia. It is the most significant risk factor for dislocation of the knee cap, been present in >85% of patients with this. There remains no consensus on the cause. In the hip, one of the risk factors for malformation of the socket with which the thigh bone articulates (developmental dysplasia of the hip) includes things that happen soon after birth such as how the baby is carried and whether or not this allows the thigh bone to adequately impress on the socket. As such, there is a greater likelihood of developing developmental dysplasia of the hip in babies carried with hips extended compared to hips astride. It may be therefore that events soon after birth that affect whether or not the knee cap imprints on the trochlea also affect trochlea development. Infants differ in their method of early mobilisation. They may crawl, which places direct pressure on the knee cap likely causing it to imprint the trochlea. They may however bottom shuffle or go straight to walking. These do not place direct pressure on the knee cap, and may therefore result in an increased risk of trochlea dysplasia, which would result in a greater chance of dislocating the knee cap in later life. The aim is to find out if there is an increase in the likelihood of knee cap dislocation among people that were bottom shufflers and/or straight to walkers compared to those that crawled. Walking also changes the dynamics operating between the knee cap and the trochlea. A secondary aim will be to find out if there is any relationship between age of onset of independent walking and knee cap dislocation in later life.
Who can participate?
Patients identified retrospectively who have had an MRI scan of their knee in the last three years at university hospitals Birmingham.
What does the study involve?
A questionnaire shall be used for both the study and control groups.
What are the possible benefits and risks of participating?
No direct benefits to participants anticipated. Possible risks; Participants contact details shall be accessed without prior consent in order to contact them about the study.
Where is the study run from?
University Hospital Birmingham, Heartlands, Solihull and Good Hope hospitals. Heartlands is the lead site
When is the study starting and how long is it expected to run for?
June 2018 to December 2020
Who is funding the study?
Funded by chief investigator; Bamikole Ogunwale
Who is the main contact?
Bamikole Ogunwale
bamikole_ogunwale@hotmail.com
Trial website
Contact information
Type
Public
Primary contact
Dr Bamikole Ogunwale
ORCID ID
Contact details
Radiology Department
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Type
Scientific
Additional contact
Mr Bamikole Ogunwale
ORCID ID
Contact details
Radiology Department
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2017092RD
Study information
Scientific title
Transient patella dislocation and mode of early mobilisation
Acronym
EMS & TPD
Study hypothesis
Determine if the mode of mobilisation used by babies pre-walking influences risk of patella dislocation in later life.
Ethics approval
East Midlands - Leicester South Research Ethics Committee, 02/01/2018, ref. 17/EM/0445
Study design
Case controlled study, single centre, observational
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Transient patella dislocation
Intervention
Participants shall be identified via a search of the radiology database using keywords. Questionnaires shall then be sent to participants asking them to identify their mode of mobilisation before walking and age at which they started walking. There will be no follow-up.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The type of early mobilisation used by patients with transient patella dislocation will be measured using a questionnaire developed for this study.
Secondary outcome measures
The age of independent walking (age at which first five unaided steps were taken) in patients with transient patella dislocation. will be determined using a questionnaire.
Overall trial start date
11/06/2018
Overall trial end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 10 to 35 years
2. Transient patella dislocation on MRI in last 3 years
3. Able to read English
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
100
Participant exclusion criteria
N/A
Recruitment start date
21/07/2018
Recruitment end date
31/12/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Heartlands Hospital
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Trial participating centre
Solihull Hospital
Lode Lane
Solihull
B91 2JL
United Kingdom
Trial participating centre
Good Hope Hospital
Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Plan to publish in a peer reviewed journal depending on results. Plan to present at relevant scientific meetings depending on results.
IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
21/12/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list