RecruitingACTRN12613000298718

Prevention of Inflammation in Perthes Disease Using Steroid Injections

Prevention of Inflammation in Perthes Disease: Steroid Injections a Novel Treatment


Sponsor

The Children's Hospital at Westmead

Enrollment

40 participants

Start Date

Oct 1, 2012

Study Type

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

Sex: Both males and femalesMin Age: 4 YearssMax Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

Perthes disease is a childhood condition where the ball part of the hip joint temporarily loses its blood supply, causing the bone to die and reshape over time. It can cause pain, stiffness, and limping in children, and recovery can take years. This study is testing whether injecting a long-acting steroid (triamcinolone hexacetonide) into the hip joint can reduce inflammation, improve movement, reduce pain, and lead to a better hip shape — possibly even shortening the duration of the disease. You may be eligible if: - Your child is between 4 and 12 years of age - Your child has been diagnosed with Perthes disease on x-ray and MRI - Your child has not had previous surgery for this condition - Your child has less than 20 degrees of hip movement on extension You may NOT be eligible if: - The hip bone death is caused by something other than Perthes disease - Your child has previously been treated with bisphosphonates - Your child is pregnant or sexually active without using contraception - Your child has a significant medical or psychiatric condition that might prevent them from completing the study Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 w

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)

The Children's Hospital at Westmead - Westmead

NSW, Australia

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ACTRN12613000298718


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