Knee cap dislocation and mode of movement in babies

ISRCTN ISRCTN13851516
DOI https://doi.org/10.1186/ISRCTN13851516
Secondary identifying numbers 2017092RD
Submission date
03/01/2019
Registration date
07/01/2019
Last edited
11/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Bamikole Ogunwale
Public

Radiology Department
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Mr Bamikole Ogunwale
Scientific

Radiology Department
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Study information

Study designCase controlled study, single centre, observational
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleTransient patella dislocation and mode of early mobilisation
Study acronymEMS & TPD
Study objectivesDetermine if the mode of mobilisation used by babies pre-walking influences risk of patella dislocation in later life.
Ethics approval(s)East Midlands - Leicester South Research Ethics Committee, 02/01/2018, ref. 17/EM/0445
Health condition(s) or problem(s) studiedTransient patella dislocation
InterventionParticipants 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 typeOther
Primary outcome measureThe type of early mobilisation used by patients with transient patella dislocation will be measured using a questionnaire developed for this study.
Secondary outcome measuresThe 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 study start date11/06/2018
Completion date31/12/2019

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants100
Key inclusion criteria1. Age 10 to 35 years
2. Transient patella dislocation on MRI in last 3 years
3. Able to read English
Key exclusion criteriaN/A
Date of first enrolment21/07/2018
Date of final enrolment31/12/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Birmingham Heartlands Hospital
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Solihull Hospital
Lode Lane
Solihull
B91 2JL
United Kingdom
Good Hope Hospital
Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom

Sponsor information

University Hospitals Birmingham
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/014ja3n03

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date21/12/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlan to publish in a peer reviewed journal depending on results. Plan to present at relevant scientific meetings depending on results.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

11/01/2019: Internal review.