Overview

Aspirin in the Prevention of Collapse in Osteonecrosis of the Hip

Status:
Unknown status
Trial end date:
2021-11-01
Target enrollment:
0
Participant gender:
All
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 of involvement of the femoral head by the necrotic process The design is intended to be parallel group where a total of 114 patients will be randomized in a 1:1 ratio to the treatment (ASA) and the control (Placebo) arms.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
McGill University Health Center
McGill University Health Centre/Research Institute of the McGill University Health Centre
Treatments:
Aspirin
Criteria
Inclusion Criteria:

1. Age 18-60 years old

2. Patients with early osteonecrosis of the hip as defined above

3. Diagnosis confirmed within 3 months of the screening visit

4. Patients accept to take the study medication

Exclusion Criteria:

1. A history of hip trauma or surgery affecting the hip involved with early stage
osteonecrosis as per criteria above

2. Concurrent use of anticoagulants

3. Concurrent use of bisphosphonates

4. Concurrent use of Aspirin for any reason

5. Patients with recent active severe peptic ulcer disease that are not on PPI.

6. 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

7. Patients who are hypersensitive to ASA, salicylates, or non-steroidal
anti-inflammatory drugs

8. 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

9. Platelets number should be more than 100,000 ( > 100 x 109 /L)

10. Pregnancy. If the patient is not sure whether she may be pregnant or not, a screening
for pregnancy should be done.