Trial Review

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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] 295739 0
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 309138 0
Condition category
Condition code
Musculoskeletal 308017 308017 0 0
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] 312065 0
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] 307011 0
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] 307011 0
2 years post treatment
Secondary outcome [1] 353815 0
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] 353815 0
2 years
Secondary outcome [2] 353907 0
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] 353907 0
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?
No
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
44
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 23633 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 300330 0
Charities/Societies/Foundations
Name [1] 300330 0
Hip Arthroscopy Education research trust Fund
Country [1] 300330 0
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] 299768 0
None
Name [1] 299768 0
Address [1] 299768 0
Country [1] 299768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301141 0
University of Melbourne Psychology Health and Applied Sciences Human Ethics Sub-Committee
Ethics committee address [1] 301141 0
Alan Gilbert Building,
Level 5, The University of Melbourne,
161 Barry Street, Victoria 3010
Ethics committee country [1] 301141 0
Australia
Date submitted for ethics approval [1] 301141 0
04/10/2018
Approval date [1] 301141 0
05/11/2018
Ethics approval number [1] 301141 0
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 85994 0
A/Prof Jane Fitzpatrick
Address 85994 0
Sports Medicine Professionals Pty Ltd
21 Erin Street
Richmond VICTORIA 3121
Country 85994 0
Australia
Phone 85994 0
+61 3 94296444
Fax 85994 0
+61 3 94216144
Email 85994 0
[email protected]
Contact person for public queries
Name 85995 0
Sally Boyd
Address 85995 0
Sports Medicine Professionals Pty Ltd
21 Erin Street
Richmond VICTORIA 3121
Country 85995 0
Australia
Phone 85995 0
+61 3 94296444
Fax 85995 0
+61 3 94216144
Email 85995 0
[email protected]
Contact person for scientific queries
Name 85996 0
Jane Fitzpatrick
Address 85996 0
Sports Medicine Professionals Pty Ltd
21 Erin Street
Richmond VICTORIA 3121
Country 85996 0
Australia
Phone 85996 0
+61 3 94296444
Fax 85996 0
+61 3 94216144
Email 85996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.