Aspirin in the Prevention of Collapse in Osteonecrosis of the Hip
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|ClinicalTrials.gov Identifier: NCT03405974|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteonecrosis of Femoral Head Osteonecrosis; Aseptic, Idiopathic||Drug: Aspirin Drug: Placebo||Phase 3|
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 according to the Ficat & Arlet or Steinberg classifications at last patient follow-up compared to initial radiological staging. This translates into lack of progression over the course of the study while the natural evolution is progression over time.
The secondary objective is to evaluate the percentage of involvement of the femoral head on radiographs and/or MRI which measures the extent of the disease. We expect that the extent of the disease will be reduced at 2 years.
- STUDY DESIGN AND DURATION This study is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that aims to test the efficacy of the proposed medical intervention (ASA). 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.
All patients presenting to the osteonecrosis clinic of one of the participating centres will be first evaluated by an orthopedic surgeon to confirm the diagnosis of early ONFH on at least one hip. Selected patients will be screened for eligibility according to specific inclusion and exclusion criteria.
Eligible patients who accept to participate in this study will be randomized to either a control arm (placebo) or a treatment arm (Aspirin). Recruited patient will take their assigned treatment daily at breakfast from enrolment and for a minimum of two years They will be followed over a period of 2 years. Evaluations will be taken at baseline and every 6 months (5 visits in total).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that aims to test the efficacy of the proposed medical intervention (ASA). 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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
Due to the objectives of the study, the identity of ASA and Placebo treatments will not be known to investigators, research staff, or patients. Access to the randomization code will be strictly controlled in order to ensure double-blind administration of study treatments. Packaging and labeling of ASA and Placebo treatments will be identical to maintain the blind.
All of the study drug profiles will be prepared in order to be identical in appearance to preserve the study blinding. The investigator and the subject, as well as all staff involved in the conduct or management of the study will be blinded to which treatment is assigned.
|Official Title:||Aspirin (Acetylsalicylic Acid) in the Prevention of Collapse of the Femoral Head in Early-stage Non-traumatic Osteonecrosis: a Two-year Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study|
|Actual Study Start Date :||October 12, 2017|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 1, 2021|
Aspirin 100 mg
1 tablet/ day for 2 years
Aspirin (acetylsalicylic acid)
Other Name: acetylsalicylic acid
Placebo Comparator: Placebo
1 tablet/ day for 2 years
- Evaluation of radiologic progression of osteonecrosis [ Time Frame: 6 months ]The primary endpoint is to evaluate the radiologic progression of ONFH by measuring the difference in ONFH staging according to the Ficat & Arlet or Steinberg classifications at last patient follow-up compared to initial radiological staging.
- Measure the percentage involvement of the femoral head on MRI. [ Time Frame: 6 months ]The secondary endpoint is to measure evolving extent of involvement of the femoral head on radiographs and/or MRI that measures the extent of the disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405974
|Contact: Bouziane Azeddine, Ph.D.||5149341934 ext firstname.lastname@example.org|
|McGill University Health Centre||Recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Contact: Bouziane Azeddine, Ph.D. 5149341934 ext 45543 email@example.com|
|Principal Investigator: Chantal Séguin, MD|
|Principal Investigator:||Chantal Séguin, MD||McGill University Health Centre/Research Institute of the McGill University Health Centre|