Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000677707
Ethics application status
Approved
Date submitted
23/11/2012
Date registered
20/06/2013
Date last updated
18/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effectiveness of Platelet-Rich Plasma Injections in Gluteal Tendonopathy – A Randomised, Double-Blind Controlled Trial
Scientific title
In Gluteal Tendonopathy, how does Platelet-Rich Plasma Injection compare to Cortisone Injection in terms of Modified Harris Hip Score 12-weeks Post-procedure?
Secondary ID [1] 280955 0
Nil
Universal Trial Number (UTN)
U1111-1133-2013
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gluteal Tendonopathy 287055 0
Condition category
Condition code
Musculoskeletal 287383 287383 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single platelet-rich plasma (PRP) injection (Biomet Biologics), injected intra-tendonously. This will be performed only once during the trial. Patents receiving the PRP procedure will have 55 mls of blood taken. The blood is placed in a balanced centrifuge and spun for 15 minutes. The resulting 7 mL (approx) of platelet-rich plasma is then injected.
Intervention code [1] 285393 0
Treatment: Other
Comparator / control treatment
A single injection of Celestone Chronodose (cortisone), 5.7ml as a single dose, injected intra-tendonously. Patients receiving the Cortisone treatment will have 55 mls blood taken.
Control group
Active

Outcomes
Primary outcome [1] 287653 0
Change from baseline in Modified Harris Hip Score, assessing patient ratings of hip function, pain and activity.
Timepoint [1] 287653 0
12 weeks post-intervention
Secondary outcome [1] 298585 0
Safety - occurrence of adverse events. Patients will be asked about possible adverse events at each patient follow-up, and also encouraged to report them to the investigators at any time during the trial. No adverse events have been pre-specified as likely.
Timepoint [1] 298585 0
Throughout the trial, in particular at each patient follow-up. Patients will be asked about possible adverse events, and also encouraged to report them to the investigators at any time during the trial. Follow-up of patients will take place 2 weeks, 6 weeks, 3 months and 12 months post-treatment. Total planned trial duration is 12 months.

Eligibility
Key inclusion criteria
Trial patients can be men or women, aged between 18 and 80 years inclusive, with gluteus medius and/or minimus tendonopathy
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
tears of the tendons on MRI and ultrasound, a history of breast cancer, previous hip surgery, current warfarin treatment, recent back surgery or sciatic pain, or cortisone treatment in the previous six weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed. All subjects will have blood taken. This will be spun to yield the PRP, or the blood is discarded depending on the allocation. The PRP or Cortisone will be presented concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence was generated with PROC PLAN (SAS procedure). Block randomisation was used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2013
Actual
29/05/2013
Date of last participant enrolment
Anticipated
30/04/2015
Actual
3/06/2015
Date of last data collection
Anticipated
Actual
2/09/2015
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1139 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 6983 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 285742 0
Self funded/Unfunded
Name [1] 285742 0
Dr Jane Fitzpatrick
Country [1] 285742 0
Australia
Primary sponsor type
Individual
Name
Dr Jane Fitzpatrick
Address
21 Erin St, Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 284568 0
Individual
Name [1] 284568 0
Dr John O'Donnell
Address [1] 284568 0
21 Erin Street, Richmond VIC 3121
Country [1] 284568 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288448 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [1] 288448 0
89 Bridge Road
Richmond
VIC 3121
Ethics committee country [1] 288448 0
Australia
Date submitted for ethics approval [1] 288448 0
23/11/2012
Approval date [1] 288448 0
01/05/2013
Ethics approval number [1] 288448 0

Summary
Brief summary
The trial's main purpose is to test the effectiveness of platelet-rich plasma (PRP) injections in patients who have painful gluteal tendonopathies. The trial aims to see if PRP use in patients who have gluteal tendonopathies reduces pain and improves functional levels at 12 weeks follow-up, compared to cortisone injection. No data exist on the use of PRP in gluteal tendonopathies. A small, uncontrolled study carried out by the investigators showed promising results. Therefore we want to study the use of PRP injections in patients with gluteal tendonopathy prospectively, in a double-blind randomised, controlled trial.
Trial website
Trial related presentations / publications
The Effectiveness of Platelet-Rich Plasma Injections in Gluteal Tendinopathy. A Randomized, Double-Blind Controlled Trial Comparing a Single Platelet-Rich Plasma Injection With a Single Corticosteroid Injection. Jane Fitzpatrick,Max K. Bulsara,John O’Donnell, Paul Robert McCrory,
and Ming Hao Zheng The American Journal of Sports Medicine 2018 1–7 DOI: 10.1177/0363546517745525
Public notes

Contacts
Principal investigator
Name 34523 0
Dr Jane Fitzpatrick
Address 34523 0
Sports Medicine Professionals Pty Ltd, 21 Erin Street, Richmond VIC 3121
Country 34523 0
Australia
Phone 34523 0
+61 (0)3 9429 6444
Fax 34523 0
Email 34523 0
[email protected]
Contact person for public queries
Name 17770 0
Dr Dr Jane Fitzpatrick
Address 17770 0
Sports Medicine Professionals Pty Ltd 21 Erin Street Richmond VIC 3121
Country 17770 0
Australia
Phone 17770 0
+61 (0)3 94296444
Fax 17770 0
Email 17770 0
[email protected]
Contact person for scientific queries
Name 8698 0
Dr Dr Jane Fitzpatrick
Address 8698 0
Sports Medicine Professionals Pty Ltd, 21 Erin Street, Richmond VIC 3121
Country 8698 0
Australia
Phone 8698 0
+61 (0)3 94296444
Fax 8698 0
Email 8698 0
[email protected]

No information has been provided regarding IPD availability


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.