Prevention of Inflammation in Perthes Disease Using Steroid Injections
Prevention of Inflammation in Perthes Disease: Steroid Injections a Novel Treatment
The Children's Hospital at Westmead
40 participants
Oct 1, 2012
Interventional
Conditions
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.
Eligibility
Inclusion Criteria4
- Boys and girls aged 4 years to 12 years old (inclusive)
- Unilateral Perthes disease diagnosed on x-ray and confirmed on Gadolinium enhanced MRI,
- No previous operative interventions
- Less than 20 degrees of abduction in hip extension.
Exclusion Criteria4
- Femoral head AVN not due to Perthes disease.
- Previous treatment with bisphosphonates.
- Current pregnancy or sexually active and not using a medically acceptable form of birth control of both male and female participants
- 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.
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Interventions
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.
Locations(1)
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ACTRN12613000298718