Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001016628
Ethics application status
Approved
Date submitted
4/09/2014
Date registered
22/09/2014
Date last updated
22/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects Of Intraarticular Platelet Rich Plasma versus Steroid Injection In Meniscal Injuries- A Randomized Controlled Trial
Scientific title
A randomised controlled trial to evaluate the effect of intraarticular platelet rich plasma injection versus intraarticular triamcinolone acetonide injection on pain relief and functional outcomes in adult males with meniscal injuries
Secondary ID [1] 285288 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meniscal injuries 292956 0
Condition category
Condition code
Musculoskeletal 293251 293251 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two intraarticular knee injection of 3 ml of platelet rich plasma will be given 2 weeks apart in total. Platelet rich plasma will be obtained from patient's own blood. 30 ml of venous blood will be taken from the patient, which will yield 3 ml of Platelet rich plasma.
Intervention code [1] 290189 0
Treatment: Other
Intervention code [2] 290234 0
Treatment: Drugs
Comparator / control treatment
A single intraarticular knee injection of 80 mg of triamcinolone acetonide will be administered
Control group
Active

Outcomes
Primary outcome [1] 293101 0
Knee pain will be assessed using Visual analogue scale (VAS)
Timepoint [1] 293101 0
At baseline, 4 and 12 weeks ater intervention
Secondary outcome [1] 310338 0
Knee injury and osteoarthritis outcome score (KOOS) will be used to assess the knee function, symptomatic improvement, pain, stiffness in knee,
Timepoint [1] 310338 0
At baseline, 4 and 12 weeks ater intervention
Secondary outcome [2] 310503 0
patient satisfaction in YES/NO
Timepoint [2] 310503 0
0,4, 12 weeks
Secondary outcome [3] 310560 0
Adverse events including: 1. Increase in pain
2. Swelling
3. Difficulty in walking
Timepoint [3] 310560 0
0,4 12 weeks

Eligibility
Key inclusion criteria
Age more than 18 yrs,
knee pain lasting more than 3 months,
History of twisting injury to knee,
Clinical and MRI evidence of meniscal injuries
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Other Intraarticular knee injections in last 3 months

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/07/2014
Actual
7/07/2014
Date of last participant enrolment
Anticipated
7/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6337 0
Pakistan
State/province [1] 6337 0
sindh

Funding & Sponsors
Funding source category [1] 289910 0
Hospital
Name [1] 289910 0
Combined Military Hospital, Panoaqil
Country [1] 289910 0
Pakistan
Primary sponsor type
Hospital
Name
Combined military hospital, Panoaqil cantt
Address
street number 2, H-block , postcode 65120. Panoaqil cantt, District Sukkur, province Sindh, Pakistan.
Country
Pakistan
Secondary sponsor category [1] 288599 0
None
Name [1] 288599 0
Address [1] 288599 0
Country [1] 288599 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291629 0
CMH Panoaqil ethics committee
Ethics committee address [1] 291629 0
CMH ethics committee, street number 2, H-block , postcode 65120. Panoaqil city, District Sukkur, province Sindh, Pakistan.
Ethics committee country [1] 291629 0
Pakistan
Date submitted for ethics approval [1] 291629 0
24/05/2014
Approval date [1] 291629 0
02/06/2014
Ethics approval number [1] 291629 0
09/PNL-HEC/2014

Summary
Brief summary
This interventional study is meant to see the efficacy of platelet rich plasma therapy in meniscal injuries. As the meniscal injuries are quite common among the sportsmen and active service military personnel, which results in lingering pain and functional limitations so this study is carried out to compare the short term functional outcomes after PRP and steroid injections.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51238 0
Dr Sarah Razaq
Address 51238 0
Major Sarah Razaq, classified rehab specialist, Rehab department, Combined Military Hospital, Panoaqil cantt (65120), distt Sukkur, Sindh, Pakistan
Country 51238 0
Pakistan
Phone 51238 0
+923336123022
Fax 51238 0
Email 51238 0
docsr@hotmail.com
Contact person for public queries
Name 51239 0
Dr Sarah Razaq
Address 51239 0
Major Sarah Razaq, classified rehab specialist, Rehab department, Combined Military Hospital, Panoaqil cantt (65120), distt Sukkur, Sindh, Pakistan
Country 51239 0
Pakistan
Phone 51239 0
+923336123022
Fax 51239 0
Email 51239 0
docsr@hotmail.com
Contact person for scientific queries
Name 51240 0
Dr Sarah Razaq
Address 51240 0
Major Sarah Razaq, classified rehab specialist, Rehab department, Combined Military Hospital, Panoaqil cantt (65120), distt Sukkur, Sindh, Pakistan
Country 51240 0
Pakistan
Phone 51240 0
+923336123022
Fax 51240 0
Email 51240 0
docsr@hotmail.com

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
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Documents added automatically
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