Condition category
Musculoskeletal Diseases
Date applied
05/02/2018
Date assigned
23/02/2018
Last edited
13/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
X-ray images are a primary tool in investigating diseases of the hip joint. The reproducibility of this examination is especially important for diagnosis and monitoring of arthritis and following hip replacement surgery. Pelvis x-rays are routinely performed with the patient lying down, however some studies have shown that standing is more effective, demonstrating abnormalities taking into consideration the effect of load. Previous research has demonstrated that the pelvis tilts with different postures (i.e. lying, sitting, standing) and understanding these changes to the resultant x-ray image is vital. Importantly, no research has considered the radiation dose implications of changing from supine to standing technique. The aim of this study is to examine the differences in diagnostic markers and radiation dose between the different positions in three phases.

Who can participate?
Adults aged 18 and older who are referred for a pelvis or hip x-ray and are able to stand unaided.

What does the study involve?
This study includes two phases. In phase, participants have their height, weight and trunk diameter/circumference measured whilst erect and supine (laying on their back). They have the standard supine pelvis X-ray performed. For phase two, an anthropomorphic phantom will then be utilised to establish the imaging protocol to provide suitable quality images with the lowest radiation dose. The third phase of the study will then recruit more participants who have been referred for pelvis or hip x-rays and they will have their imaging performed in both lying and standing positions. The recruitment and refusal rates are used to inform future study design and confirm sample size. The data will assist in determining variation in radiation dose, anatomical measures for hip disease and anatomy between positions.

What are the possible benefits and risks of participating?
No direct benefit will be received by participants in the study. There are no anticipated risks associated with participation.

Where is the study run from?
Pinderfields Hospital (UK)

When is the study starting and how long is it expected to run for?
November 2017 to May 2018

Who is funding the study?
Society and College of Radiographers (SCoR) (UK)

Who is the main contact?
Miss Martine Harris (Scientific)
martine.harris@midyorks.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Martine Harris

ORCID ID

http://orcid.org/0000-0003-1924-3718

Contact details

Mid Yorkshire Hospitals NHS Trust
Rowan House
Room G.08
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
+44 1924 542297
martine.harris@midyorks.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36407

Study information

Scientific title

A pilot study to compare supine and erect pelvis radiographs – assessment of impact on radiation dose and diagnostic quality

Acronym

Study hypothesis

This feasibility study aims to determine if patient posture (erect or supine) has an effect on soft tissue anatomy (body shape/size). We want to identify the implications of postural changes on radiation dose and image quality for X-Ray examination.

The study objectives are to:
1. Identify radiation dose and image quality metrics
2. Determine the scope of a future research study proposal, including trial procedures, imaging protocols and patient information
3. Identify the recruitment and refusal rates to such research.

Ethics approval

Yorkshire & The Humber - South Yorkshire Research Ethics Committee, 14/12/2017, ref: 17/YH/0363

Study design

Non-randomised; Interventional; Design type: Diagnosis, Imaging, Other

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

See additional files

Condition

Specialty: Musculoskeletal disorders, Primary sub-specialty: Other; UKCRC code/ Disease: Musculoskeletal/ Other osteopathies

Intervention

In phase 1 the participants have measures undertaken in the supine and erect position but just have the standard supine pelvis X-Ray performed.

During phase 3 a new cohort of participants are recruited to have measures and an additional pelvis X-Ray taken in the erect position in addition to the standard supine pelvis X-Ray.

There is no follow-up post intervention in either phase.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Difference in abdominal soft tissue thickness, measured by a researcher with a tape measure (in cm) in supine and erect position at baseline (incorporating phase 1 & 3 data).

Secondary outcome measures

1. Difference in abdominal circumference, measured (in cm) in supine and erect position at baseline (incorporating phase 1 & 3 data)
2. BMI will be calculated using height and weight measurements obtained at baseline (incorporating phase 1 & 3 data).
3. Difference in radiation dose between X-Rays performed in supine and erect position as measured by dose area product (DAP) at baseline (phase 3).
4. Image quality variation between supine and erect X-Rays performed at baseline will be measured using a validated psychometric scale (phase 3).

Overall trial start date

29/11/2017

Overall trial end date

12/06/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Phase 1:
1. Patients over the age of 18 who attend for x-ray of the hip or pelvis from a MYH OP clinic or their GP
2. Able to stand unaided
3. Have not had lower limb surgery in the last six months
4. Able to provide written informed consent.

Phase 3:
1. Patients who over the age of 18 attend for x-ray of the hip or pelvis from a MYH OP or their GP
2. Not pregnant
3. Able to provide written informed consent
4. Able to stand unaided
5. Have not had recent trauma or a pelvic x-ray or pelvic radiotherapy in the preceding 6 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 240; UK Sample Size: 240

Participant exclusion criteria

Patients who are under the age of 18, pregnant, have undergone lower limb surgery within the previous six months or are unable to provide written informed consent will be excluded from the study. A further exclusion will be related to patients who are unable to stand unaided, as the ability to weight bear would be a key component in performance of an x-ray in the erect posture.

Recruitment start date

15/01/2018

Recruitment end date

31/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Pinderfields Hospital
Rowan House
Wakefield
WF1 4DG
United Kingdom

Sponsor information

Organisation

Mid Yorkshire Hospitals NHS Trust

Sponsor details

Rowan House
Aberford Road
Wakefield
WF1 4EE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Society and College of Radiographers (SCoR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. The intention is to publish by December 2018.
Please see additional files for protocol version 1.4.

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

31/12/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Editorial Notes

13/07/2018: The trial end date was changed from 31/05/2018 to 12/06/2018. 23/02/2018: Uploaded protocol version 1.4. 05 Dec 2017 (not peer-reviewed).