Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000298718
Ethics application status
Approved
Date submitted
11/03/2013
Date registered
18/03/2013
Date last updated
19/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention of Inflammation in Perthes Disease Using Steroid Injections
Scientific title
Prevention of Inflammation in Perthes Disease: Steroid Injections a Novel Treatment
Secondary ID [1] 282107 0
None
Universal Trial Number (UTN)
Trial acronym
PIP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perthes Disease 288602 0
Condition category
Condition code
Musculoskeletal 288934 288934 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All study patients will continue to get the routine orthopaedic treatment for Perthes Disease that is currently offered by their orthopaedic surgeon. The standard of care for Perthes disease varies widely. Going to the operating room to remove fluid (synovial) from the affected hip and placing a dye in the joint is one of the most common treatments for Perthes that assist the surgeon to better understand the hip and decide on future treatment.
In addition to the above, patients in the study will be randomised into one of two (2) groups:
Group 1 Will go to the theatre and undergo fluid aspirate of the hip (have fluid removed from the hip through a needle), arthrogram (dye in the hip joint), as well as an intra-articular injection of Triamcinolone Hexacetanide at 1mg/kg/joint which is a long acting steroid, mixed with 1% Ropivacaine (anesthetic). They will then have broomstick casting applied to both legs to keep the legs abducted (i.e. spread). At the time of the anaesthetic, they will also have a blood test done (5ml), through the same needle used to insert a cannula for the surgery.

The operative procedure consists of performing, with the patient under general anaesthesia, a hip joint aspirate of synovial fluid (fluid removed from the hip) with a needle syringe. Once the aspirate is taken, a dye is injected into the joint and appropriate position is confirmed by fluoroscopy. The active or placebo syringe is then attached to the needle and the fluid is injected.

The needle is then removed and the hip examined fluoroscopically in differing positions (Anterior-posterior (AP), abduction AP and frog lateral). A broom stick cast is then applied to maintain an abducted position post-operatively for 2 weeks. During the procedure, whilst the patient is asleep, a blood test will be drawn and sent for analysis for markers of inflammation that appear in the serum.

Patients (regardless of randomised group) who fail to show significant improvement in their range of movement (Abduction more than 10 degrees AND Abduction < 20 degrees in extension) at Week 12 will have re-surgery and treated with an intra-articular injection of Triamcinolone Hexacetanide at 1mg/kg/joint which is a long acting steroid, mixed with 1% Ropivacaine along with a second Arthrogram.
Intervention code [1] 286709 0
Treatment: Drugs
Intervention code [2] 286749 0
Treatment: Surgery
Comparator / control treatment
Group 2: Will go to the theatre and undergo fluid aspirate of the hip (have fluid removed from the hip through a needle), arthrogram (dye in the hip joint), as well as an intra-articular injection of Saline (Sodium chloride 0.9%) mixed with 1% Ropivacaine. Broomstick casting will be applied to both legs to keep the legs abducted (i.e. spread). They will not have the steroids injected into their hip. At the time of the anaesthetic, they will also have a blood test done (5ml), through the same needle used to insert a cannula for the surgery.

Patients (regardless of randomised group) who fail to show significant improvement in their range of movement (Abduction more than 10 degrees AND Abduction < 20 degrees in extension) at Week 12 will have re-surgery and treated with an intra-articular injection of Triamcinolone Hexacetanide at 1mg/kg/joint which is a long acting steroid, mixed with 1% Ropivacaine along with a second Arthrogram.
Control group
Placebo

Outcomes
Primary outcome [1] 289061 0
Changes in Range of Movement (ROM). This will be assessed by blinded physiotherapists who will perform all the ROM measurements on all the patients. The blinded physiotherapists will be assessing in degrees with a goniometer: Abduction, Adduction, Internal rotation, External rotation, flexion and fixed flexion deformity.
Timepoint [1] 289061 0
Week 2, Week 6, Month 3, Month 6, Month 9 and Month 12 compared to screening.
Secondary outcome [1] 301659 0
Radiographs (AP, AP abduction and frog lateral) will be assessed for:
- Sphericity
- Congruency of the hip
- Reduction of Shenton’s line (i.e. measuring subluxation)
- Reimer’s migration index and femoral head uncovering
- Deformity index.
Timepoint [1] 301659 0
Month 3, 6, 9 and 12 compared to screening.
Secondary outcome [2] 301660 0
Limp assessment scale to assess degree of limping by parents
Timepoint [2] 301660 0
Week 2, Week 6, Month 3, Month 6, Month 9 and Month 12 compared to screening.
Secondary outcome [3] 301661 0
Faces-pain scale
Timepoint [3] 301661 0
Week 2, Week 6, Month 3, Month 6, Month 9 and Month 12 compared to screening.

Eligibility
Key inclusion criteria
1. Boys and girls aged 4 years to 12 years old (inclusive)
2. Unilateral Perthes disease diagnosed on x-ray and confirmed on Gadolinium enhanced MRI,
3. No previous operative interventions
4. Less than 20 degrees of abduction in hip extension.
Minimum age
4 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Femoral head AVN not due to Perthes disease.
2. Previous treatment with bisphosphonates.
3. Current pregnancy or sexually active and not using a medically acceptable form of birth control of both male and female participants
4. History of clinically significant organic or psychiatric disease or findings on physical examination, which in the opinion of the Investigator would prevent the patient from completing 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 732 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 6532 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 286875 0
Hospital
Name [1] 286875 0
The Children's Hospital at Westmead
Country [1] 286875 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Cnr of Hawkesbury Rd and Hainsworth St, Westmead,
NSW 2145
Country
Australia
Secondary sponsor category [1] 285666 0
None
Name [1] 285666 0
Address [1] 285666 0
Country [1] 285666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288938 0
The Sydney Children’s Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 288938 0
Ethics committee country [1] 288938 0
Australia
Date submitted for ethics approval [1] 288938 0
Approval date [1] 288938 0
22/08/2011
Ethics approval number [1] 288938 0
10/CHW/117

Summary
Brief summary
This study is looking at the effect of Triamcinolone Hexacetonide, a long acting steroid (drug that decreases inflammation and pain) on the hip bone shape in children and adolescents with Perthes Disease. We will look to see if this drug is able to help improve range of movement, function, reduce pain and result in better overall outcomes for patients with Perthes disease. We also believe this drug may shorten the overall duration of the disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38418 0
Prof David Little
Address 38418 0
Orthopaedic Research and Biotechnology,
The Children's Hospital at Westmead,
Cnr of Hawkesbury Road and Hainsworth Street,
Westmead, NSW 2145
Country 38418 0
Australia
Phone 38418 0
+61298450000
Fax 38418 0
Email 38418 0
[email protected]
Contact person for public queries
Name 38419 0
Ms Sheetal Reddy
Address 38419 0
Institute of Endocrinology and Diabetes,
The Children's Hospital at Westmead,
Cnr of Hawkesbury Road and Hainsworth Street,
Westmead, NSW 2145
Country 38419 0
Australia
Phone 38419 0
+61298453179
Fax 38419 0
Email 38419 0
[email protected]
Contact person for scientific queries
Name 38420 0
Prof David Little
Address 38420 0
Orthopaedic Research and Biotechnology,
The Children's Hospital at Westmead,
Cnr of Hawkesbury Road and Hainsworth Street,
Westmead, NSW 2145
Country 38420 0
Australia
Phone 38420 0
+61298450000
Fax 38420 0
Email 38420 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

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