Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT04092634
Eligibility Criteria:
Inclusion Criteria:
* Primary THA for a diagnosis of osteoarthritis or inflammatory arthritis in the setting of a history of prior lumbar or lumbosacral fusion performed at least 6 months prior to their THA. In addition, patients considered high-risk for potential prosthetic dislocation will be included based on the presence of one or more of the following: neuromuscular disorder (e.g. cerebral palsy, Parkinson's disease, history of a stroke), dementia or cognitive impairment, substance or alcohol abuse (\>10 drinks per week), acute displaced femoral neck fracture, age \> 75 years, inflammatory arthritis, and increased preoperative range of motion (calculated as described by Krenzel et al.: combined flexion, adduction, internal rotation \> 115 degrees).
Exclusion Criteria:
* Less than 18 years of age
* Revision THA
* spinopelvic fusion that is more recent than 6 months prior to THA
* isolated cervical or thoracic fusion
* intent to undergo a revision spinopelvic fusion within one year of their index THA
* a history of prior infection in the affected hip
* a history of prior open surgery on the affected hip (i.e. prior proximal femur fracture or osteotomy)
* or a preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04092634
Study Brief:
Protocol Section:
NCT04092634