Prevention of Inflammation in Perthes Disease Using Steroid Injections
Recruiting
- Conditions
- Perthes DiseaseMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12613000298718
- Lead Sponsor
- The Children's Hospital at Westmead
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. [Week 2, Week 6, Month 3, Month 6, Month 9 and Month 12 compared to screening.]
- Secondary Outcome Measures
Name Time Method Radiographs (AP, AP abduction and frog lateral) will be assessed for:<br>- Sphericity<br>- Congruency of the hip<br>- Reduction of Shenton’s line (i.e. measuring subluxation)<br>- Reimer’s migration index and femoral head uncovering<br>- Deformity index. [Month 3, 6, 9 and 12 compared to screening.];Limp assessment scale to assess degree of limping by parents[Week 2, Week 6, Month 3, Month 6, Month 9 and Month 12 compared to screening.];Faces-pain scale[Week 2, Week 6, Month 3, Month 6, Month 9 and Month 12 compared to screening.]