Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000984998
Ethics application status
Approved
Date submitted
12/09/2011
Date registered
15/09/2011
Date last updated
25/06/2019
Date data sharing statement initially provided
25/06/2019
Date results information initially provided
25/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
PRP (Autologous Platelet rich plasma) may improve hip arthroscopy patients outcome.
Scientific title
In patients undergoing hip arthroscopy, how would platelet rich plasma, compared with placebo, improve post operative outcome in the short and long term.
Secondary ID [1] 263033 0
Nil
Universal Trial Number (UTN)
U1111-1124-5099
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The study Will include patients who elect to go through a surgical procedure in order to treat a pre existing hip injury such as FAI (Femoral acetabular impingement). 270759 0
Condition category
Condition code
Musculoskeletal 270940 270940 0 0
Other muscular and skeletal disorders
Surgery 270959 270959 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment group would be treated with platelets concentrate prepared from their own blood (which was drown by 4 regular 5 cc blood collecting tubes). The concentrate will be applied to the operated area (hip) 24 hours after the surgery via a drainage left
at the site during the procedure.
Intervention code [1] 269374 0
Treatment: Other
Comparator / control treatment
Placebo group will go through the same process as above without applying the PRP concentrate into the joint. instead the same volume of saline would be administrated.
Control group
Placebo

Outcomes
Primary outcome [1] 279608 0
Suffer from less surgical known side effects such as long term incidental pain or activity restrictions.
MAHORN validated questioner.
Timepoint [1] 279608 0
1,3,6,12 months
Secondary outcome [1] 294029 0
To have a better cartilage and labral healing as seen on MRI
Timepoint [1] 294029 0
6, 12 month

Eligibility
Key inclusion criteria
1. healthy patients undergoing hip Arthroscopy due to FAI
2. Ages 16-50
3. No OA changes according to XR and surgery observation
4. No previous hip surgery
5. No other influential disabilities in lower limbs 6. No chronic use of NSAID, steroids or chemotherapy drugs
Minimum age
16 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-ambulating patients, those with severe advanced osteoarthritic changes on radiological imaging, patients with suspected previous joint infection, pregnant or lactating women, open wounds or skin ulcers and those taking anticoagulants or having a prolonged bleeding time were excluded.

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 was concealed using numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/09/2011
Actual
20/09/2011
Date of last participant enrolment
Anticipated
Actual
29/06/2012
Date of last data collection
Anticipated
Actual
21/06/2019
Sample size
Target
100
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 3838 0
New Zealand
State/province [1] 3838 0
AUCKLAND

Funding & Sponsors
Funding source category [1] 269833 0
Self funded/Unfunded
Name [1] 269833 0
Dr. Omer Mei-Dan
Country [1] 269833 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Omer Mei-Dan
Address
27 Prospect Terrace, Milford
0620
Auckland
Country
New Zealand
Secondary sponsor category [1] 268865 0
Individual
Name [1] 268865 0
Dr. Mat Brick
Address [1] 268865 0
Millennium Institute of Sport and Health
17 Antares Place
Mairangi Bay
North Shore City, Auckland
0632
Country [1] 268865 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271801 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 271801 0
Ministry of health, 3rd floor, BNZ building,
354 Victoria st.
PO Box 1031
Hamilton 3204
Ethics committee country [1] 271801 0
New Zealand
Date submitted for ethics approval [1] 271801 0
01/03/2011
Approval date [1] 271801 0
09/08/2011
Ethics approval number [1] 271801 0
NTY/11/04/043

Summary
Brief summary
Hip arthroscopy is a surgical treatment technique which commonly address intra articular cartilage and labral pathologies. There is a growing evidence that PRP can improve articular cartilage healing, both when applied during surgery or as a sole method of treatment, when prescribed for the proper indication. PRP injection has been proposed as a novel treatment modality for the management of articular cartilage injuries of the knee, hip and ankle. Even though high level of clinical evidence is lacking, basic research supports the use of PRP derived growth factors to improve tissue healing. There are few published clinical studies on the use of PRP in cartilage pathology. The study hypothesis is that the new treatment (PRP) would improve patients outcome after arthroscopic treatment for FAI (hip impingement).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33149 0
Dr Joshua Knudsen
Address 33149 0
Orthosports
17 Antares Pl, Rosedale, Auckland 0632
Country 33149 0
New Zealand
Phone 33149 0
+64 212011130
Fax 33149 0
Email 33149 0
[email protected]
Contact person for public queries
Name 16396 0
Dr Dr. Omer Mei-Dan
Address 16396 0
Millennium Institute of Sport and Health
17 Antares Place
Mairangi Bay
North Shore City, Auckland
0632
Country 16396 0
New Zealand
Phone 16396 0
0064 9 477 2080
Fax 16396 0
0064 9 477 2091
Email 16396 0
[email protected]
Contact person for scientific queries
Name 7324 0
Dr Dr. Omer Mei-Dan
Address 7324 0
Millennium Institute of Sport and Health
17 Antares Place
Mairangi Bay
North Shore City, Auckland
0632
Country 7324 0
New Zealand
Phone 7324 0
0064 21 883839
Fax 7324 0
0064 9 477 2091
Email 7324 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


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.