Condition category
Injury, Occupational Diseases, Poisoning
Date applied
03/01/2019
Date assigned
07/01/2019
Last edited
11/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

University Hospitals Birmingham

Sponsor details

Research and Development
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

11/01/2019: Internal review.