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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT03892005
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 75 years old, inclusive.
* Had a primary unilateral or bilateral (simultaneous or staged) THA based on physical exam and medical history, including diagnosis of severe hip pain and disability.
* Had received MOTIVATION HIPTM Total Hip System per the approved indications for use for the THA.
* No history of previous prosthetic replacement device of any type, including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip joint(s) beside investigational product.
* Willing and able to provide written informed consent by signing and dating the EC approved informed consent form.
* Willing and able to complete scheduled follow-up evaluations..
Exclusion Criteria:
* The patient is:
* A prisoner
* Mentally incompetent or unable to understand what participation in the study entails
* A known alcohol or drug abuser
* Anticipated to be non-compliant
* Has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure or complications in postoperative care.
* Has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
* Has a diagnosed systemic disease that could affect his/her safety or the study outcome.
* Known to be pregnant.
* Has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
* Insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e., osteoporosis), cancer, and radiation.
* Osteoradionecrosis in the affected hip joint.
* Known sensitivity or allergic reaction to one or more of the implanted materials.
* Known local bone tumors and/or cysts in the operative hip.
* Body Mass Index (BMI) \> 40.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03892005
Study Brief:
Protocol Section:
NCT03892005