ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001856202

Ethics application status

Approved

Date submitted

3/08/2018

Date registered

14/11/2018

Date last updated

16/04/2021

Date data sharing statement initially provided

14/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

MRI follow-up of patients following leukocyte-rich platelet-rich plasma injections for chronic gluteal tendinopathy of the hip

Scientific title

2-year radiological follow-up of patients post leukocyte-rich platelet-rich plasma injections for chronic gluteal tendinopathy

Secondary ID [1]

nil

Universal Trial Number (UTN)

U1111-1218-5225

Trial acronym

MR-PRP-HIP

Linked study record

ACTRN1261300067707 - This study is a follow up study of the previous one. The participants have undergone treatment in the associated trial and will now be followed up by MRI in addition to their previous outcome measures

Health condition

Health condition(s) or problem(s) studied:

Gluteal Tendinopathy

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This study will aim to answer the question of whether single LR-PRP injection for gluteal tendinopathy results in long term radiological improvement in imaging abnormalities to the tendons.
This will be a single-centre trial conducted as a follow up of a double-blind randomised control trial.
The subjects will be drawn from the double-blind randomised control trial along with those who were in the open labelled extension to the trial, who had a pre-study MRI.
Participants will be asked to give consent for researchers to access pre and post-treatment MRI scans. For those who have not had a post-treatment MRI, they will be asked to have an MRI scan performed. There will be no requirement for participants to attend for visits (other than to have an MRI if needed).
A radiologist will assess pre and post treatments MRI scans using a grading system. The radiologist will be blinded to the identity of the patient and to which post-trial MRI relates to which pre-trial MRI. Once the imaging has been scored statistical analysis will be used to determine whether the changes are significant. This is anticipated to be completed over a 9 month period.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Pre treatment MRIs will be compared to post treatments MRIs in two groups - one who has had leucocyte-rich PRP ( LR-PRP) and the control group who has had a corticosteroid injection

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome measure will be the MHIP Score. This grading system has 5 components which contribute to the composite score. The degree of trochanteric bursitis is scored from 0-4, the tendon pathology from 0-5, muscle atrophic changes from 0-4, Cortical irregularity from 0-3 and Bone marrow oedema from 0-1 with a total score ranging from 0-17. Scores will be measured at baseline and 2 years

Timepoint [1]

2 years post treatment

Secondary outcome [1]

Secondary outcome: stratifying variables (responder vs non responder) correlation between Melbourne MHIP MRI tendon Grading system scores at baseline and 2 years Responders will be determined by the Relative Effect per Patient of > 0.2 (based on Huber and OMERACT-OARSI criteria)

Timepoint [1]

2 years

Secondary outcome [2]

Secondary outcome: stratifying variables (responder vs non responder) correlation between Melbourne MHIP MRI tendon Grading system scores at baseline and 2 years Responders will be determined by a Patient Acceptable Symptomatic State score (PASS Score) of >74 on the MHHS

Timepoint [2]

2 years post treatment

Eligibility

Key inclusion criteria

All subjects from the initial LR-PRP or CSI arms of the double-blind randomised control trial that weren’t lost to follow up along with those who were in the open labelled extension to the trial who had a pre-study MRI.

Minimum age

15 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Subjects who did not have a pre-study MRI in the RCT

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

The sample size is expected to be 44 subjects. This is the number of RCT patients with pre-intervention MRI in the LR-PRP and crossover groups.
The data collected will be analysed using STATA statistical package. Significance will be p >0.05. Standard t-tests will be performed at each timepoint for comparison between groups.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

28/02/2019

Actual

7/11/2019

Date of last participant enrolment

Anticipated

28/02/2020

Actual

31/07/2020

Date of last data collection

Anticipated

31/03/2020

Actual

30/09/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3121 - Richmond

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Hip Arthroscopy Education research trust Fund

Address [1]

21 Erin Street, Richmond VICTORIA 3121

Country [1]

Australia

Primary sponsor type

Individual

Name

A/Prof Jane Fitzpatrick

Address

Sports Medicine Professional Pty Ltd
21 Erin Street. Richmond VICTORIA 3121

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Psychology Health and Applied Sciences Human Ethics Sub-Committee

Ethics committee address [1]

Alan Gilbert Building, 
Level 5, The University of Melbourne, 
161 Barry Street, Victoria 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/10/2018

Approval date [1]

05/11/2018

Ethics approval number [1]

1852900

Summary

Brief summary

Gluteal tendinopathy is a degenerative condition of the hip. A recent randomized control trial showed that a single injection of platelet-rich plasma was associated with improvement of gluteal tendinopathy. This study will aim to assess whether imaging changes can be identified in the study population.   The aim is to assess whether single LR-PRP or corticosteroid injection for gluteal tendinopathy results in improvement in gluteal tendon appearance on MRI at 2 years post intervention. The primary outcome measure will be statistically significant improvement in tendon imaging abnormalities on 2 year follow up MRI compared to pre-treatment MRI. MRIs will be reviewed and graded by an experienced radiologist. Gluteal tendon changes will be graded based upon a previously published gluteal tendinopathy MRI grading score.

A secondary outcome measure will be statistically significant correlation with clinical improvement as described in the original randomised control trial by Fitzpatrick et al . 
This will be a single-centre trial conducted as a  follow up of a double-blind randomised control trial. 
The subjects will be all subjects from the double-blind randomised control trial that weren’t lost to follow up along with those who were in the open labelled extension to the trial who had a pre-study MRI. 
An experienced radiologist will assess pre and post LR-PRP RCT MRI using a validated grading system. The radiologist will be blinded to the identity of the patient and to which post-trial MRI relates to which pre-trial MRI. Once the imaging has been scored statistical analysis will be used to determine whether the changes are significant. They will also be compared to the clinical changes seen in the randomised control trial to assess any statistical correlation in the two measures.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Jane Fitzpatrick

Address

Sports Medicine Professionals Pty Ltd
21 Erin Street
Richmond VICTORIA 3121

Country

Australia

Phone

+61 3 94296444

Fax

+61 3 94216144

sportsdocoz@gmail.com

Contact person for public queries

Name

Sally Boyd

Address

Sports Medicine Professionals Pty Ltd
21 Erin Street
Richmond VICTORIA 3121

Country

Australia

Phone

+61 3 94296444

Fax

+61 3 94216144

sportsdocoz@gmail.com

Contact person for scientific queries

Name

Jane Fitzpatrick

Address

Sports Medicine Professionals Pty Ltd
21 Erin Street
Richmond VICTORIA 3121

Country

Australia

Phone

+61 3 94296444

Fax

+61 3 94216144

sportsdocoz@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

The data from the individual participants in this study will be collated and analysed and published in a transparent comprehensive fashion which would allow for meaningful subsequent analysis or meta analysis by research groups.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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