Status:
UNKNOWN
Aspirin in the Prevention of Collapse in Osteonecrosis of the Hip
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Osteonecrosis of Femoral Head
Osteonecrosis; Aseptic, Idiopathic
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if prolonged administration of low-dose aspirin will prevent the progression of early-stage osteonecrosis of the femoral head and may even reduce the extent o...
Detailed Description
1. TRIAL OBJECTIVES The primary objective of this study is to evaluate the radiologic progression of ONFH on either radiographs or MRI. A successful outcome is defined as no difference in ONFH staging...
Eligibility Criteria
Inclusion
- Age 18-60 years old
- Patients with early osteonecrosis of the hip as defined above
- Diagnosis confirmed within 3 months of the screening visit
- Patients accept to take the study medication
Exclusion
- A history of hip trauma or surgery affecting the hip involved with early stage osteonecrosis as per criteria above
- Concurrent use of anticoagulants
- Concurrent use of bisphosphonates
- Concurrent use of Aspirin for any reason
- Patients with recent active severe peptic ulcer disease that are not on PPI.
- Patients with advanced osteonecrosis of the hip with signs of collapse or end-stage joint arthritis of the hip that are immediately referred for surgical consultation for THA
- Patients who are hypersensitive to ASA, salicylates, or non-steroidal anti-inflammatory drugs
- Hepatic impairment (Bilirubin total, AST, ALT \> 2-3x upper limit of normal), renal failure (creatinine level above normal with glomerular filtration rate \< 45 ml/minute), or congestive heart failure
- Platelets number should be more than 100,000 ( \> 100 x 109 /L)
- Pregnancy. If the patient is not sure whether she may be pregnant or not, a screening for pregnancy should be done.
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03405974
Start Date
October 12 2017
End Date
November 1 2021
Last Update
January 24 2018
Active Locations (1)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4