Overview
The Use of Bisphosphonates in the Treatment of Avascular Necrosis of the Femoral Head
Status:
Terminated
Terminated
Trial end date:
2013-06-01
2013-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To determine the safety and effectiveness of pamidronate in patients with radiographically proven avascular necrosis which are the result of unstable (acute) slipped capital femoral epiphysis, traumatic proximal femur fractures, traumatic hip dislocations, or idiopathic in nature.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
The Hospital for Sick ChildrenTreatments:
Diphosphonates
Pamidronate
Criteria
Inclusion Criteria:Patients between the ages of 10 and 18 with:
- unstable slipped capital femoral epiphysis (defined as inability to bear weight) or
acute slipped capital femoral epiphysis (defined as a separation of the epiphysis from
the metaphysis of the proximal femur) who have been pinned either in situ or following
reduction,
- traumatic hip dislocations or traumatic proximal femur fractures, or
- "idiopathic" avascular necrosis of the femoral head which includes unknown causes as
well as Sickle Cell Disease, post radiation use, post chemotherapy treatment, and post
steroid treatment.
Exclusion Criteria:
- Decline to participate in study. (Patients will be still offered this therapy whether
or not they wish to be included in the official study protocol. Clinical evaluations,
laboratory and imaging tests would be unchanged if they choose to be treated with
intravenous pamidronate)
- Significant femoral head collapse - judged radiographically by treating surgeon
- Idiopathic causes under the age of 10.