Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Postero-Lateral Approach | Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery. | 1 | None | 0 | 44 | 6 | 44 | View |
| Direct Anterior Approach | Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed. | 1 | None | 0 | 43 | 5 | 43 | View |