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Trial registered on ANZCTR


Registration number
ACTRN12615001225505p
Ethics application status
Not yet submitted
Date submitted
22/10/2015
Date registered
9/11/2015
Date last updated
9/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Platelet-rich plasma, in addition to usual surgical care for chronic greater trochanteric pain syndrome: a single blinded randomised controlled trial
Scientific title
Endoscopic iliotibial band release and trochanteric bursectomy with and without adjuvant platelet-rich plasma for recalcitrant greater trochanteric pain syndrome, outcomes on pain and physical function: a single blinded randomised controlled trial
Secondary ID [1] 287723 0
None
Universal Trial Number (UTN)
U1111-1175-7640
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recalcitrant greater trochanteric pain syndrome 296557 0
Condition category
Condition code
Musculoskeletal 296820 296820 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 296840 296840 0 0
Other inflammatory or immune system disorders
Surgery 296841 296841 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Surgical release of iliotibial band and excision of trochanteric bursa (control)

Arm 2: Surgical release of iliotibial band and excision of trochanteric bursa with single intraoperative injection of platelet-rich plasma into gluteus medius musculotendinous junction

The procedure is performed with the patient lying on their unaffected side. If the patient is to receive PRP, 55ml of blood is extracted from a patient's vein while they are anaesthetised and spun down using a device to gain 6ml of platelet-rich plasma which is injected immediately after the surgical intervention is complete, via the endoscopic portals. The procedure involves a longitudinal split of the ITB and excision of the bursa and take approximately 30 minutes.
Intervention code [1] 293109 0
Treatment: Surgery
Intervention code [2] 293110 0
Treatment: Devices
Comparator / control treatment
The control group will receive the surgery (iliotibial band release and trochanteric bursectomy) without the injection of platelet-rich plasma
Control group
Active

Outcomes
Primary outcome [1] 296419 0
Pain measured on visual analogue scale
Timepoint [1] 296419 0
This data will be collected pre-operatively at an appointment in the surgeons private rooms. We will aim to standardise this to occur within 1-4 weeks prior to surgery but may change based on the surgeon's and patient's availability to perform and undergo surgery respectively.

This will also be collected post-operatively at 6 weeks, 6 months, 12 months and 24 months after intervention via a mail out of the survey.
Primary outcome [2] 296420 0
Pain and function measured on Oxford hip score (composite 12 question patient reported outcome measure assessing both pain and function)
Timepoint [2] 296420 0
This data will be collected pre-operatively at an appointment in the surgeons private rooms. We will aim to standardise this to occur within 1-4 weeks prior to surgery but may change based on the surgeon's and patient's availability to perform and undergo surgery respectively.

This will also be collected post-operatively at 6 weeks, 6 months, 12 months and 24 months after intervention via a mail out of the survey.
Primary outcome [3] 296421 0
Pain and function measured on international hip outcome tool 33 (iHOT-33) - (composite 33 question patient reported outcome measure assessing both pain and function)
Timepoint [3] 296421 0
This data will be collected pre-operatively at an appointment in the surgeons private rooms. We will aim to standardise this to occur within 1-4 weeks prior to surgery but may change based on the surgeon's and patient's availability to perform and undergo surgery respectively.

This will also be collected post-operatively at 6 weeks, 6 months, 12 months and 24 months after intervention via a mail out of the survey.
Secondary outcome [1] 318399 0
Patient satisfaction measured using 5 point Likert scale
Timepoint [1] 318399 0
This data will be collected post-operatively at 6 weeks, 6 months, 12 months and 24 months after intervention via a mail out of the survey.
Secondary outcome [2] 318400 0
Patient subjective likelihood to have reoperation if pain returned measured using 5 point Likert scale
Timepoint [2] 318400 0
This data will be collected post-operatively at 6 weeks, 6 months, 12 months and 24 months after intervention via a mail out of the survey.

Eligibility
Key inclusion criteria
Adult > 18yrs old

Greater trochanteric pain syndrome (GTPS) diagnosed clinically by principal investigator according to following criteria (must have number 1+2 and one of 3-5):
1. History of aching pain on lateral aspect of hip
2. Distinct tenderness about the greater trochanter
3. Pain at extremes of hip rotation
4. Pain on strong contraction of hip abductors
5. Pseudoradiculopathy down thigh

Have had minimum 6 months of symptoms

Failed minimum of 6 months of non-operative management (including rest, physiotherapy and corticosteroid injection)

Undergone minimum of 1 previous corticosteroid injection into area about greater trochanter

Have optimised medical management (control of medical comorbidities, on appropriate analgesics as required)

Have ultrasound or MRI showing signs of GTPS (gluteal tendinopathy and/or bursitis) without a full thickness gluteal muscle or tendon tear

Have hip X-ray showing no or mild arthritis (Tonnis grade 0 or 1)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any previous surgery on affected hip (e.g. arthroscopy, total hip replacement)

Previous platelet-rich plasma (PRP) injection into affected hip region

Other pathology involving affected hip that can mimic pain of GTPS (e.g. hip arthritis grade 2-3, labral tear, femoroacetabular impingement, ligamentum teres tear, lumbar radiculopathy, hip dysplasia, fibromyalgia

Full thickness gluteal muscle/tendon tear on affected side

Does not speak English

Unable to complete questionnaires due to mental/physical comorbidities

Person is known to have a psychological, developmental, physical, emotional or social disorder that may interfere with compliance with study requirements

Conditions where PRP is contraindicated and patient will be excluded:
1. History of severe uncontrolled diabetes mellitus
2. Platelet abnormality or platelet count < 100 x 109 /L
3. Haematological disorder
4. Serum haemoglobin < 11 g/dL
5. Use of systemic cortisone
6. Use of any anticoagulant
7. Evidence of gangrene/ulcers or peripheral vascular disease
8. History of hepatic or renal impairment or dialysis
9. History of alcohol or drug abuse
10. Person has a religious or cultural conflict with the use of platelet gel treatment or blood products
11. Has inadequate venous access for blood draw
12. Is currently receiving or has received radiation or chemotherapy within the last 3 months prior to the study
13. Pregnant women, or women who are lactating or planning pregnancy during the course of the study

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)
Individuals are randomised by a computer-generated list by securenvelope, an online computer generated randomisation service, maintained centrally.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple random allocation via securenvelope, an online computer generated randomisation service.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Our hypothesis is that a single PRP injection into the gluteus medius tendon at the time of surgery for recalcitrant GTPS will result in a clinically relevant improvement in patient’s pain and function. We have selected a sample size (total 128, 64 each group) that will be viable for recruiting from a single surgeon while being powered enough to detect a 25% difference between groups with an alpha value of 0.05 and a beta value of 0.2.

Continuous data such as VAS, OHS, iHOT33 score, age and BMI will be reported in terms of the mean and 95% confidence interval. The means of continuous data between intervention arms will be compared using the t-test.

Dichotomous data such as gender, diabetes and smoking will be compared using the Chi2 test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2016
Actual
Date of last participant enrolment
Anticipated
1/01/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4501 0
Bellbird Private Hospital - Blackburn
Recruitment hospital [2] 4569 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment hospital [3] 4570 0
Specialist Orthopaedic Surgery Clinic - East Melbourne
Recruitment postcode(s) [1] 10700 0
3130 - Blackburn
Recruitment postcode(s) [2] 12183 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 292267 0
Hospital
Name [1] 292267 0
Western Health
Country [1] 292267 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
160 Gordon St, Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 290944 0
None
Name [1] 290944 0
None
Address [1] 290944 0
None
Country [1] 290944 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293739 0
St Vincent's HREC D
Ethics committee address [1] 293739 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy, VIC 3065
Ethics committee country [1] 293739 0
Australia
Date submitted for ethics approval [1] 293739 0
17/11/2015
Approval date [1] 293739 0
Ethics approval number [1] 293739 0

Summary
Brief summary
This is a parallel randomised controlled trial analysing the effect of adding a singular intra-operative platelet-rich plasma (PRP) injection into the gluteus medius tendon to current surgical standard of care consisting of endoscopic iliotibial band release and trochanteric bursectomy for recalcitrant greater trochanteric pain syndrome (GTPS). The singular PRP injection will be administered at the time of surgery while the patient is anaesthetised. The study aims to investigate whether adding PRP injection to surgery confers any additional reduction in pain and improvement in function compared to surgery alone.

This study will be conducted as a randomised controlled trial with the control arm receiving the current surgical standard of care, consisting of endoscopic iliotibial band release and trochanteric bursectomy, without PRP. The experimental arm will receive the same surgical intervention but with an additional single PRP injection into the gluteus medius tendon.

Our hypothesis is there will be an improvement in the experimental group with the addition of PRP. We are hoping this will result in a change in standard practice for this group of patients, whereby patients who undergo this operation receive PRP concurrently.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61122 0
Mr Phong Tran
Address 61122 0
ATTN: Lidia Carbone (orthopaedic Secretary)
Department of Orthopaedics, Western Health
Western Hospital
Level 1 South, 160 Gordon St
Footscray, VIC 3011
Country 61122 0
Australia
Phone 61122 0
+61 3 8345 7575
Fax 61122 0
+61 3 8345 7579
Email 61122 0
[email protected]
Contact person for public queries
Name 61123 0
James Drummond
Address 61123 0
ATTN: Lidia Carbone (Orthopaedic Secretary)
Department of Orthopaedics, Western Health
Western Hospital
Level 1 South, 160 Gordon St
Footscray, VIC 3011
Country 61123 0
Australia
Phone 61123 0
+61 3 8345 7575
Fax 61123 0
+61 3 8345 7579
Email 61123 0
[email protected]
Contact person for scientific queries
Name 61124 0
James Drummond
Address 61124 0
ATTN: Lidia Carbone (Orthopaedic Secretary)
Department of Orthopaedics, Western Health
Western Hospital
Level 1 South, 160 Gordon St
Footscray, VIC 3011
Country 61124 0
Australia
Phone 61124 0
+61 3 8345 7575
Fax 61124 0
+61 3 8345 7579
Email 61124 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.